GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes

A Double-blind [Sponsor Unblinded], Randomized, Placebo-controlled, Staggered-parallel Study to Investigate the Safety, Tolerability, and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes

Lead sponsor

GlaxoSmithKline

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 18-35•Healthy volunteers

Primary endpoints

•Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part (Treatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint))•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint))•Documented hypoglycemia

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01725126

Org study ID116623

Timeline

Milestones

Study first posted2012-11-12estimated

Study start2013-02-10actual

Primary completion2013-09-12actual

Study completion2013-09-12actual

Results first posted2017-10-23actual

Last update posted2017-12-13actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

Part A (Healthy Subjects)

•Subject able to understand and voluntarily provide the consent to participate in the study

•18 - 70 years of age, inclusive, at the time of signing the informed consent and Body Mass Index (BMI) between 18.0 and 35.0 Kilogram (kg) per m^2, inclusive

•Understands and is willing, able and likely to be compliant with taking study drug and comply with all study procedures and restrictions

•Subject is willing to consume the foods that are part of the standardized breakfast, lunch, and dinner

•In good general health with no clinically significant and relevant abnormalities of medical history or physical examination which includes adequate renal function, alanine transaminase (ALT), alkaline phosphatase and bilirubin <=1.5x Upper Limit of Normal (ULN )

•QTcF < 450 millisecond (msec); or QTcF < 480msec for subjects with right Bundle Branch Block

•Females must be post-menopausal

•Females on hormone replacement therapy (HRT) must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment

•Females who are > 3 months postpartum and who have undergone a surgical sterilization procedure are eligible to participate in consultation with the GSK Medical Monitor

Parts B and C (Type 2 Diabetic Subjects)

•All the criteria mentioned in Part A except Body Mass Index (BMI) should be between 30.0 and 42.0 kg per m^2

•Diagnosis of T2D for at least 3 months, as defined by the American Diabetes Association

•All T2D subjects must meet label recommendations for metformin

•For Part B, subjects must be willing to discontinue metformin and replace it with daily liraglutide administered by subcutaneous injection and they must meet label recommendations

•No personal history or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2

Exclusion criteria

•History of gastrointestinal disease, current or chronic history of liver disease, history of serious, severe or unstable physical or psychiatric illness , significant cardiovascular disease, surgery for weight loss or gastrointestinal surgery within 3 months of screening, any documented or reported eating disorder, uncontrolled hypertension, as evidenced by systolic pressure>160 or diastolic pressure >90 mmHg

•Positive test for HIV, Hepatitis B, or Hepatitis C at Screening

•Subjects with significant ECG abnormalities

•For subjects in Part C (continuing metformin), history of untreated pernicious anemia or who have laboratory parameters suggestive of subclinical megaloblastic anemia

•Presence of or symptoms of an active infection

•Uncorrected Thyroid Dysfunction

•History of chronic or acute pancreatitis

•Currently dieting to lose weight including, but not limited to, participation in a program designed to alter body weight within the last 60 days and unwilling to maintain relatively consistent exercise patterns throughout the study

•Current or recent history (within one year of screening) of alcohol or other substance abuse

•Unable to refrain from the use of non-prescription drugs

•Current participation in another clinical study or participation in a clinical study involving an investigational drug within 30 days of the screening visit

•History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy

•An employee of the sponsor or the study site or members of their immediate family.

Endpoints (126)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Cardiometabolic biomarkers

Renal / kidney

Weight & body composition

MASH / liver

Patient-reported / QoL

Other (unclassified)

Weight & body composition

4 endpoints

Primary/registry result

Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1 and Day 1) up to Day 42

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms (kg)	95% CI
Part B-Placebo+LiraglutideDay 7	-0.12	—
Day 14	0.37	—
Day 28	0.15	—
Day 42	-0.74	—
Part B-GSK2890457+LiraglutideDay 7	0.20	—
Day 14	0.05	—
Day 28	0.47	—
Day 42	-0.39	—
Part C-Placebo+MetforminDay 7	0.28	—
Day 14	0.61	—
Day 28	0.52	—
Day 42	-0.47	—
Part C-GSK2890457+MetforminDay 7	0.47	—
Day 14	0.56	—
Day 28	0.27	—
Day 42	0.42	—

Mean Difference (Final Values)0.1995% CI-1.38 – 1.75ANCOVA

Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in body weight.

Mean Difference (Final Values)1.0895% CI-0.20 – 2.36ANCOVA

Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in body weight.

Primary/registry result

Percent Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1 and Day 1) up to Day 42

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percent change	95% CI
Part B-Placebo+LiraglutideDay 7	-0.16	—
Day 14	0.47	—
Day 28	0.25	—
Day 42	-0.80	—
Part B-GSK2890457+LiraglutideDay 7	0.18	—
Day 14	-0.04	—
Day 28	0.39	—
Day 42	-0.51	—
Part C-Placebo+MetforminDay 7	0.36	—
Day 14	0.79	—
Day 28	0.66	—
Day 42	-0.53	—
Part C-GSK2890457+MetforminDay 7	0.59	—
Day 14	0.60	—
Day 28	0.30	—
Day 42	0.50	—

Mean Difference (Final Values)0.1195% CI-1.64 – 1.87ANCOVA

Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 percent change from Baseline in body weight.

Mean Difference (Final Values)1.2695% CI-0.24 – 2.75ANCOVA

Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 percent change from Baseline in body weight.

Primary/protocol endpoint

Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1 and Day 1) up to Day 42

Body weight, absolute change (kg)

change from baseline, improvement

Primary/protocol endpoint

Percent Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1 and Day 1) up to Day 42

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

18 endpoints

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Picomoles (pmol)/L	95% CI
Part A-PlaceboDay 7	-1.256	—
Day 14	8.072	—
Day 28	-11.659	—
Day 42	-22.721	—
Part A-GSK2890457Day 7	12.516	—
Day 14	1.973	—
Day 28	8.969	—
Day 42	-13.735	—

Primary/registry result/low confidence

Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, improvement

Posted result

Group	Value (mean), pmol/L	95% CI
Part B-Placebo+LiraglutideDay 7	-20.21	—
Day 14	-21.65	—
Day 28	-53.41	—
Day 42	-12.99	—
Part B-GSK2890457+LiraglutideDay 7	-20.05	—
Day 14	-9.62	—
Day 28	-35.18	—
Day 42	-8.12	—
Part C-Placebo+MetforminDay 7	45.11	—
Day 14	-79.39	—
Day 28	34.28	—
Day 42	34.28	—
Part C-GSK2890457+MetforminDay 7	-29.59	—
Day 14	-41.14	—
Day 28	-7.22	—
Day 42	35.28	—

Primary/registry result

Change From Baseline in Weighted Mean Glucose Area Under the Curves From Time 0 to 24 Hours (AUC [0-24 Hours]) During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Part B-Placebo+LiraglutideAUC (0-4 hour)	0.018	—
AUC (0-24 hour)	-0.613	—
Part B-GSK2890457+LiraglutideAUC (0-4 hour)	-0.164	—
AUC (0-24 hour)	-0.968	—
Part C-Placebo+MetforminAUC (0-4 hour)	1.194	—
AUC (0-24 hour)	1.376	—
Part C-GSK2890457+MetforminAUC (0-4 hour)	0.341	—
AUC (0-24 hour)	0.156	—

Mean Difference (Final Values)-0.18295% CI-1.694 – 1.331ANCOVA

Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.

Mean Difference (Final Values)-0.35695% CI-1.409 – 0.698ANCOVA

Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.

Mean Difference (Final Values)-0.85395% CI-2.232 – 0.526ANCOVA

Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.

Mean Difference (Final Values)-1.21995% CI-2.447 – 0.009ANCOVA

Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.

Primary/registry result

Change From Baseline in Fasting Glucose During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42 of Part B and C

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Part B-Placebo+Liraglutide	-0.384	—
Part B-GSK2890457+Liraglutide	-0.230	—
Part C-Placebo+Metformin	0.136	—
Part C-GSK2890457+Metformin	-0.387	—

Mean Difference (Final Values)0.15595% CI-1.277 – 1.587ANCOVA

Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in fasting glucose.

Mean Difference (Final Values)-0.52495% CI-1.939 – 0.892ANCOVA

Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in fasting glucose.

Primary/registry result/low confidence

Change From Baseline in Fasting Insulin and Weighted Mean Insulin AUC (0-4 Hour) and AUC (0-24 Hour) During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

change from baseline, improvement

componentsfasting insulin change, insulin auc 0 4h change, insulin auc 0 24h change

Posted result

Group	Value (mean), pmol/L	95% CI
Part B-Placebo+LiraglutideFasting Insulin	-4.887	—
Insulin Weighted Mean AUC 0-4 hour	69.635	—
Insulin Weighted Mean AUC 0-24 hour	1.626	—
Part B-GSK2890457+LiraglutideFasting Insulin	1.133	—
Insulin Weighted Mean AUC 0-4 hour	14.589	—
Insulin Weighted Mean AUC 0-24 hour	-13.905	—
Part C-Placebo+MetforminFasting Insulin	-11.946	—
Insulin Weighted Mean AUC 0-4 hour	57.887	—
Insulin Weighted Mean AUC 0-24 hour	22.740	—
Part C-GSK2890457+MetforminFasting Insulin	12.300	—
Insulin Weighted Mean AUC 0-4 hour	10.322	—
Insulin Weighted Mean AUC 0-24 hour	17.134	—

Primary/registry result

Change From Baseline in Glycated Hemoglobin (HbA1c) During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percent of TL hemoglobin	95% CI
Part B-Placebo+Liraglutide	-0.214	—
Part B-GSK2890457+Liraglutide	-0.278	—
Part C-Placebo+Metformin	0.018	—
Part C-GSK2890457+Metformin	-0.201	—

Mean Difference (Final Values)-0.06595% CI-0.495 – 0.365ANCOVA

Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in HbA1c.

Mean Difference (Final Values)-0.21995% CI-0.910 – 0.472ANCOVA

Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in HbA1c.

Primary/registry result

Change From Baseline in Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR]) During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), mU*mmol/L^2	95% CI
Part B-Placebo+Liraglutide	-0.150	—
Part B-GSK2890457+Liraglutide	0.017	—

Primary/registry result

Change From Baseline in Matsuda Index During the Double Blind-treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

change from baseline, improvement

Posted result

Group	Value (mean), DecilitermL/mgmU	95% CI
Part B-Placebo+Liraglutide	-0.991	—
Part B-GSK2890457+Liraglutide	-0.602	—

Primary/registry result

Change From Baseline in Fasting Plasma Glucose (Safety Laboratory) Values During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Follow-up (Day 56)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Part B-Placebo+LiraglutideDay 7	-0.278	—
Day 14	-0.093	—
Day 28	-0.111	—
Day 42	0.194	—
Follow-up	0.962	—
Part B-GSK2890457+LiraglutideDay 7	0.285	—
Day 14	0.210	—
Day 28	-0.201	—
Day 42	-0.098	—
Follow-up	0.444	—
Part C-Placebo+MetforminDay 7	0.879	—
Day 14	0.518	—
Day 28	1.536	—
Day 42	1.184	—
Follow-up	1.249	—
Part C-GSK2890457+MetforminDay 7	-1.665	—
Day 14	-2.216	—
Day 28	-1.989	—
Day 42	0.074	—
Follow-up	-1.226	—

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Weighted Mean Glucose Area Under the Curves From Time 0 to 24 Hours (AUC [0-24 Hours]) During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Fasting Glucose During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42 of Part B and C

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Primary/protocol endpoint

Change From Baseline in Fasting Insulin and Weighted Mean Insulin AUC (0-4 Hour) and AUC (0-24 Hour) During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change From Baseline in Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR]) During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Matsuda Index During the Double Blind-treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (Safety Laboratory) Values During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Follow-up (Day 56)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

MASH / liver

4 endpoints

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), ALT, Aspartate Aminotransferase (AST) and Gamma Glutamyltransferase (GGT) During Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, improvement

componentsALT, change, AST, change, γ-GT, change

Posted result

Group	Value (mean), International unit per liter (IU/L)	95% CI
Part A-PlaceboALP, Day 7	-6.0	—
ALP, Day 14	-1.3	—
ALP, Day 28	0.0	—
ALP, Day 42	-1.0	—
ALT, Day 7	5.5	—
ALT, Day 14	1.3	—
ALT, Day 28	2.0	—
ALT, Day 42	5.3	—
AST, Day 7	2.3	—
AST, Day 14	-2.3	—
AST, Day 28	-0.8	—
AST, Day 42	2.3	—
GGT, Day 7	1.5	—
GGT, Day 14	1.0	—
GGT, Day 28	0.8	—
GGT, Day 42	2.5	—
Part A-GSK2890457ALP, Day 7	-3.8	—
ALP, Day 14	-1.4	—
ALP, Day 28	-1.8	—
ALP, Day 42	-1.8	—
ALT, Day 7	-4.1	—
ALT, Day 14	-4.4	—
ALT, Day 28	-8.2	—
ALT, Day 42	-7.7	—
AST, Day 7	-0.4	—
AST, Day 14	1.4	—
AST, Day 28	-3.1	—
AST, Day 42	-0.3	—
GGT, Day 7	-0.1	—
GGT, Day 14	-0.1	—
GGT, Day 28	-2.9	—
GGT, Day 42	-0.5	—

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of ALP, ALT, AST and GGT During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

ALT, change

change from baseline, improvement

LOINC 1742-6

Posted result

Group	Value (mean), IU/L	95% CI
Part B-Placebo+LiraglutideALP, Day 7	5.3	—
ALP, Day 14	5.2	—
ALP, Day 28	-0.3	—
ALP, Day 42	4.3	—
ALT, Day 7	-1.3	—
ALT, Day 14	-2.3	—
ALT, Day 28	-2.5	—
ALT, Day 42	-4.3	—
AST, Day 7	-1.2	—
AST, Day 14	-1.3	—
AST, Day 28	-2.0	—
AST, Day 42	-3.8	—
GGT, Day 7	0.7	—
GGT, Day 14	0.8	—
GGT, Day 28	0.0	—
GGT, Day 42	-0.7	—
Part B-GSK2890457+LiraglutideALP, Day 7	5.5	—
ALP, Day 14	1.8	—
ALP, Day 28	2.8	—
ALP, Day 42	2.2	—
ALT, Day 7	-0.1	—
ALT, Day 14	0.6	—
ALT, Day 28	0.9	—
ALT, Day 42	1.0	—
AST, Day 7	1.1	—
AST, Day 14	1.9	—
AST, Day 28	2.2	—
AST, Day 42	3.8	—
GGT, Day 7	-1.2	—
GGT, Day 14	-1.4	—
GGT, Day 28	0.8	—
GGT, Day 42	0.2	—
Part C-Placebo+MetforminALP, Day 7	1.8	—
ALP, Day 14	6.7	—
ALP, Day 28	6.3	—
ALP, Day 42	0.5	—
ALT, Day 7	1.5	—
ALT, Day 14	3.0	—
ALT, Day 28	0.7	—
ALT, Day 42	-0.5	—
AST, Day 7	-0.5	—
AST, Day 14	-1.0	—
AST, Day 28	0.7	—
AST, Day 42	1.0	—
GGT, Day 7	0.3	—
GGT, Day 14	5.3	—
GGT, Day 28	2.3	—
GGT, Day 42	-0.7	—
Part C-GSK2890457+MetforminALP, Day 7	-2.2	—
ALP, Day 14	-3.7	—
ALP, Day 28	-2.5	—
ALP, Day 42	-2.8	—
ALT, Day 7	-1.0	—
ALT, Day 14	-6.3	—
ALT, Day 28	-3.8	—
ALT, Day 42	-4.2	—
AST, Day 7	0.2	—
AST, Day 14	-0.3	—
AST, Day 28	1.4	—
AST, Day 42	1.9	—
GGT, Day 7	1.3	—
GGT, Day 14	2.3	—
GGT, Day 28	0.5	—
GGT, Day 42	-0.9	—

Primary/protocol endpoint

Time frame:Baseline (Day 1, Randomization) up to Day 42

ALT, change

change from baseline, improvement

LOINC 1742-6

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameters of ALP, ALT, AST and GGT During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

ALT, change

change from baseline, improvement

LOINC 1742-6

Renal / kidney

6 endpoints

Primary/registry result

Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part A

Time frame:Up to Day 42

ratio, descriptive

Posted result

Group	Value (mean), Ratio	95% CI
Part A-PlaceboDay 1	1.0193	—
Day 7	1.0133	—
Day 14	1.0153	—
Day 28	1.0125	—
Day 42	1.0155	—
Part A-GSK2890457Day 1	1.0175	—
Day 7	1.0165	—
Day 14	1.0152	—
Day 28	1.0122	—
Day 42	1.0161	—

Primary/registry result

Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part B and C

Time frame:Up to Day 42

ratio, descriptive

Posted result

Group	Value (mean), Ratio	95% CI
Part B-Placebo+LiraglutideDay -1	1.0168	—
Day 7	1.0208	—
Day 14	1.0202	—
Day 28	1.0232	—
Day 42	1.0137	—
Part B-GSK2890457+LiraglutideDay -1	1.0174	—
Day 7	1.0191	—
Day 14	1.0196	—
Day 28	1.0239	—
Day 42	1.0188	—
Part C-Placebo+MetforminDay -1	1.0172	—
Day 7	1.0197	—
Day 14	1.0198	—
Day 28	1.0213	—
Day 42	1.0110	—
Part C-GSK2890457+MetforminDay -1	1.0187	—
Day 7	1.0208	—
Day 14	1.0201	—
Day 28	1.0213	—
Day 42	1.0172	—

Primary/registry result

Mean pH Values of Urine During the Double-blind Treatment Period of Part A

Time frame:up to Day 42

descriptive

Posted result

Group	Value (mean), pH	95% CI
Part A-PlaceboDay 1	5.25	—
Day 7	5.88	—
Day 14	5.50	—
Day 28	6.13	—
Day 42	5.63	—
Part A-GSK2890457Day 1	5.95	—
Day 7	5.86	—
Day 14	5.91	—
Day 28	6.05	—
Day 42	6.20	—

Primary/protocol endpoint

Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part A

Time frame:Up to Day 42

descriptive

Primary/protocol endpoint

Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part B and C

Time frame:Up to Day 42

descriptive

Primary/protocol endpoint

Mean pH Values of Urine During the Double-blind Treatment Period of Part A

Time frame:up to Day 42

descriptive

Cardiometabolic biomarkers

8 endpoints

Primary/registry result

Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

Systolic BP, change

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

LOINC 8480-6

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Part A-PlaceboSBP, Day 7	0.8	—
SBP, Day 14	-0.5	—
SBP, Day 28	-3.3	—
SBP, Day 42	-1.0	—
DBP, Day 7	-5.3	—
DBP, Day 14	-1.8	—
DBP, Day 28	-1.3	—
DBP, Day 42	-0.8	—
Part A-GSK2890457SBP, Day 7	-4.0	—
SBP, Day 14	-3.9	—
SBP, Day 28	-5.5	—
SBP, Day 42	-7.5	—
DBP, Day 7	-6.2	—
DBP, Day 14	-5.0	—
DBP, Day 28	-8.4	—
DBP, Day 42	-6.4	—

Primary/registry result

Change From Baseline in Vital Sign Parameter of SBP and DBP During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mmHg	95% CI
Part B-Placebo+LiraglutideSBP, Day 7	1.6	—
SBP, Day 14	5.6	—
SBP, Day 28	-0.6	—
SBP, Day 42	-2.6	—
DBP, Day 7	-2.4	—
DBP, Day 14	2.1	—
DBP, Day 28	-3.3	—
DBP, Day 42	-1.5	—
Part B-GSK2890457+LiraglutideSBP, Day 7	2.0	—
SBP, Day 14	3.6	—
SBP, Day 28	0.2	—
SBP, Day 42	0.1	—
DBP, Day 7	0.4	—
DBP, Day 14	0.8	—
DBP, Day 28	0.4	—
DBP, Day 42	0.8	—
Part C-Placebo+MetforminSBP, Day 7	3.2	—
SBP, Day 14	3.2	—
SBP, Day 28	4.5	—
SBP, Day 42	0.0	—
DBP, Day 7	0.9	—
DBP, Day 14	-0.8	—
DBP, Day 28	-0.4	—
DBP, Day 42	1.1	—
Part C-GSK2890457+MetforminSBP, Day 7	-3.7	—
SBP, Day 14	-2.8	—
SBP, Day 28	-7.4	—
SBP, Day 42	-3.0	—
DBP, Day 7	-0.8	—
DBP, Day 14	-2.5	—
DBP, Day 28	-3.4	—
DBP, Day 42	-3.2	—

Primary/registry result

Change From Baseline in Vital Sign Parameter of Heart Rate (HR) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	95% CI
Part A-PlaceboDay 7	8.0	—
Day 14	6.3	—
Day 28	5.5	—
Day 42	-1.3	—
Part A-GSK2890457Day 7	4.6	—
Day 14	0.6	—
Day 28	3.3	—
Day 42	-4.4	—

Primary/registry result

Change From Baseline in Vital Sign Parameter of HR During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	95% CI
Part B-Placebo+LiraglutideDay 7	-3.6	—
Day 14	-3.3	—
Day 28	-7.8	—
Day 42	-4.8	—
Part B-GSK2890457+LiraglutideDay 7	0.3	—
Day 14	0.4	—
Day 28	3.7	—
Day 42	1.6	—
Part C-Placebo+MetforminDay 7	0.1	—
Day 14	0.8	—
Day 28	1.8	—
Day 42	-3.2	—
Part C-GSK2890457+MetforminDay 7	1.6	—
Day 14	3.6	—
Day 28	1.5	—
Day 42	0.5	—

Primary/protocol endpoint

Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

Systolic BP, change

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

LOINC 8480-6

Primary/protocol endpoint

Change From Baseline in Vital Sign Parameter of SBP and DBP During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Primary/protocol endpoint

Change From Baseline in Vital Sign Parameter of Heart Rate (HR) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

Heart rate, change

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Vital Sign Parameter of HR During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Primary/registry result

Change From Baseline in the Overall Gastrointestinal (GI) Symptoms Rating Scale (GSRS) Score During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, improvement

Posted result

Group	Value (mean), Scores on scale	95% CI
Part A-PlaceboDay 7	0.02	—
Day 14	0.08	—
Day 42	0.02	—
Part A-GSK2890457Day 7	0.08	—
Day 14	0.04	—
Day 42	-0.02	—

Primary/registry result

Change From Baseline in the Overall GSRS Score During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -2) up to Day 41

change from baseline, improvement

Posted result

Group	Value (mean), Scores on scale	95% CI
Part B-Placebo+LiraglutideDay 7	0.03	—
Day 14	-0.09	—
Day 28	-0.21	—
Day 41	-0.11	—
Part B-GSK2890457+LiraglutideDay 7	-0.03	—
Day 14	0.05	—
Day 28	0.03	—
Day 41	-0.12	—
Part C-Placebo+MetforminDay 7	0.24	—
Day 14	0.20	—
Day 28	0.14	—
Day 41	0.02	—
Part C-GSK2890457+MetforminDay 7	0.13	—
Day 14	0.28	—
Day 28	0.27	—
Day 41	0.10	—

Primary/protocol endpoint

Change From Baseline in the Overall Gastrointestinal (GI) Symptoms Rating Scale (GSRS) Score During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in the Overall GSRS Score During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -2) up to Day 41

PGI, change

change from baseline, improvement

Safety / tolerability / PK

81 endpoints

Primary/registry result

Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part A

Time frame:Up to Follow-up (8 weeks)

composite event, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint)

Posted result

Group	Value (count_of_participants), Participants	95% CI
Part A-PlaceboAny AE	3	—
Any SAE	0	—
Any Death	0	—
Part A-GSK2890457Any AE	10	—
Any SAE	0	—
Any Death	0	—

Primary/registry result

Number of Participants With Any AE, SAE or Death During Part B and Part C

Time frame:Up to Follow-up (8 weeks)

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint)

Posted result

Group	Value (count_of_participants), Participants	95% CI
Part B-Placebo+LiraglutideAny AE	1	—
Any SAE	0	—
Any Death	0	—
Part B-GSK2890457+LiraglutideAny AE	3	—
Any SAE	0	—
Any Death	0	—
Part C-Placebo+MetforminAny AE	3	—
Any SAE	0	—
Any Death	0	—
Part C-GSK2890457+MetforminAny AE	3	—
Any SAE	0	—
Any Death	0	—

Primary/registry result

Number of Participants With Any Hypoglycemic Events During Part A

Time frame:Up to Follow-up (8 weeks)

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Part A-Placebo	0	—
Part A-GSK2890457	0	—

Primary/registry result

Number of Participants With Any Hypoglycemic Events During Part B and Part C

Time frame:Up to Follow-up (8 weeks)

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Part B-Placebo+Liraglutide	0	—
Part B-GSK2890457+Liraglutide	0	—
Part C-Placebo+Metformin	0	—
Part C-GSK2890457+Metformin	0	—

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic and Urea/Blood Urea Nitrogen (BUN) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Millimoles (mmol)/L	95% CI
Part A-PlaceboCalcium, Day 7	-0.025	—
Calcium, Day 14	0.056	—
Calcium, Day 28	0.056	—
Calcium, Day 42	0.050	—
Chloride, Day 7	0.8	—
Chloride, Day 14	1.0	—
Chloride, Day 28	-1.5	—
Chloride, Day 42	-0.8	—
Carbon dioxide/Bicarbonate, Day 7	0.3	—
Carbon dioxide/Bicarbonate, Day 14	-1.0	—
Carbon dioxide/Bicarbonate, Day 28	-0.5	—
Carbon dioxide/Bicarbonate, Day 42	-2.5	—
Glucose, Day 7	-0.0	—
Glucose, Day 14	-0.0	—
Glucose, Day 28	-0.1	—
Glucose, Day 42	-0.2	—
Potassium, Day 7	0.15	—
Potassium, Day 14	0.20	—
Potassium, Day 28	-0.07	—
Potassium, Day 42	0.30	—
Magnesium, Day 7	-0.0206	—
Magnesium, Day 14	-0.0617	—
Magnesium, Day 28	-0.0411	—
Magnesium, Day 42	-0.0308	—
Sodium, Day 7	0.3	—
Sodium, Day 14	-0.3	—
Sodium, Day 28	1.0	—
Sodium, Day 42	-1.3	—
Urea/BUN, Day 7	-0.179	—
Urea/BUN, Day 14	-0.268	—
Urea/BUN, Day 28	-0.536	—
Urea/BUN, Day 42	-0.625	—
Phosphorus inorganic, Day 7	-0.07	—
Phosphorus inorganic, Day 14	-0.14	—
Phosphorus inorganic, Day 28	-0.02	—
Phosphorus inorganic, Day 42	0.01	—
Part A-GSK2890457Calcium, Day 7	-0.023	—
Calcium, Day 14	-0.023	—
Calcium, Day 28	-0.010	—
Calcium, Day 42	-0.022	—
Chloride, Day 7	1.2	—
Chloride, Day 14	0.4	—
Chloride, Day 28	0.5	—
Chloride, Day 42	0.4	—
Carbon dioxide/Bicarbonate, Day 7	-1.2	—
Carbon dioxide/Bicarbonate, Day 14	-1.9	—
Carbon dioxide/Bicarbonate, Day 28	-1.2	—
Carbon dioxide/Bicarbonate, Day 42	-2.8	—
Glucose, Day 7	-0.1	—
Glucose, Day 14	-0.3	—
Glucose, Day 28	-0.2	—
Glucose, Day 42	-0.3	—
Potassium, Day 7	-0.15	—
Potassium, Day 14	-0.15	—
Potassium, Day 28	-0.13	—
Potassium, Day 42	-0.16	—
Magnesium, Day 7	-0.0299	—
Magnesium, Day 14	-0.0486	—
Magnesium, Day 28	-0.0288	—
Magnesium, Day 42	-0.0247	—
Sodium, Day 7	0.8	—
Sodium, Day 14	-0.2	—
Sodium, Day 28	1.9	—
Sodium, Day 42	-0.6	—
Urea/BUN, Day 7	-0.325	—
Urea/BUN, Day 14	-0.746	—
Urea/BUN, Day 28	-0.643	—
Urea/BUN, Day 42	-0.678	—
Phosphorus inorganic, Day 7	-0.04	—
Phosphorus inorganic, Day 14	-0.05	—
Phosphorus inorganic, Day 28	-0.09	—
Phosphorus inorganic, Day 42	-0.03	—

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic, BUN and Cholesterol During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

componentselectrolytes panel, glucose, phosphorus inorganic, bun, cholesterol

Posted result

Group	Value (mean), mmol/L	95% CI
Part B-Placebo+LiraglutideCalcium, Day 7	0.083	—
Calcium, Day 14	0.050	—
Calcium, Day 28	0.021	—
Calcium, Day 42	-0.025	—
Chloride, Day 7	-1.5	—
Chloride, Day 14	-0.8	—
Chloride, Day 28	0.8	—
Chloride, Day 42	-1.0	—
Carbon dioxide/Bicarbonate, Day 7	0.0	—
Carbon dioxide/Bicarbonate, Day 14	-1.8	—
Carbon dioxide/Bicarbonate, Day 28	-1.0	—
Carbon dioxide/Bicarbonate, Day 42	0.5	—
Glucose, Day 7	-0.3	—
Glucose, Day 14	-0.1	—
Glucose, Day 28	-0.1	—
Glucose, Day 42	0.2	—
Potassium, Day 7	0.33	—
Potassium, Day 14	0.17	—
Potassium, Day 28	0.28	—
Potassium, Day 42	-0.05	—
Magnesium, Day 7	0.0206	—
Magnesium, Day 14	-0.0206	—
Magnesium, Day 28	0.0274	—
Magnesium, Day 42	-0.0137	—
Sodium, Day 7	1.2	—
Sodium, Day 14	1.3	—
Sodium, Day 28	1.8	—
Sodium, Day 42	0.5	—
Urea/BUN, Day 7	-0.000	—
Urea/BUN, Day 14	-0.297	—
Urea/BUN, Day 28	0.119	—
Urea/BUN, Day 42	-0.595	—
Cholesterol, Day 42	-0.853	—
Phosphorus inorganic, Day 7	0.10	—
Phosphorus inorganic, Day 14	0.01	—
Phosphorus inorganic, Day 28	0.06	—
Phosphorus inorganic, Day 42	0.01	—
Part B-GSK2890457+LiraglutideCalcium, Day 7	0.053	—
Calcium, Day 14	0.041	—
Calcium, Day 28	0.046	—
Calcium, Day 42	-0.040	—
Chloride, Day 7	-1.2	—
Chloride, Day 14	-0.1	—
Chloride, Day 28	0.2	—
Chloride, Day 42	0.2	—
Carbon dioxide/Bicarbonate, Day 7	-2.0	—
Carbon dioxide/Bicarbonate, Day 14	-1.9	—
Carbon dioxide/Bicarbonate, Day 28	-0.4	—
Carbon dioxide/Bicarbonate, Day 42	-1.8	—
Glucose, Day 7	0.3	—
Glucose, Day 14	0.2	—
Glucose, Day 28	-0.2	—
Glucose, Day 42	-0.1	—
Potassium, Day 7	0.09	—
Potassium, Day 14	0.20	—
Potassium, Day 28	0.08	—
Potassium, Day 42	0.01	—
Magnesium, Day 7	0.0294	—
Magnesium, Day 14	0.0176	—
Magnesium, Day 28	0.0379	—
Magnesium, Day 42	0.0063	—
Sodium, Day 7	0.2	—
Sodium, Day 14	1.4	—
Sodium, Day 28	1.7	—
Sodium, Day 42	-0.4	—
Urea/BUN, Day 7	0.383	—
Urea/BUN, Day 14	0.128	—
Urea/BUN, Day 28	0.302	—
Urea/BUN, Day 42	-0.412	—
Cholesterol, Day 42	-0.103	—
Phosphorus inorganic, Day 7	0.01	—
Phosphorus inorganic, Day 14	0.05	—
Phosphorus inorganic, Day 28	-0.01	—
Phosphorus inorganic, Day 42	-0.04	—
Part C-Placebo+MetforminCalcium, Day 7	0.025	—
Calcium, Day 14	0.067	—
Calcium, Day 28	0.004	—
Calcium, Day 42	-0.071	—
Chloride, Day 7	0.8	—
Chloride, Day 14	0.5	—
Chloride, Day 28	1.0	—
Chloride, Day 42	0.5	—
Carbon dioxide/Bicarbonate, Day 7	-2.0	—
Carbon dioxide/Bicarbonate, Day 14	-2.0	—
Carbon dioxide/Bicarbonate, Day 28	-2.3	—
Carbon dioxide/Bicarbonate, Day 42	-2.8	—
Glucose, Day 7	0.9	—
Glucose, Day 14	0.5	—
Glucose, Day 28	1.5	—
Glucose, Day 42	1.2	—
Potassium, Day 7	0.28	—
Potassium, Day 14	0.17	—
Potassium, Day 28	0.10	—
Potassium, Day 42	-0.05	—
Magnesium, Day 7	0.0206	—
Magnesium, Day 14	0.0069	—
Magnesium, Day 28	0.0411	—
Magnesium, Day 42	-0.0274	—
Sodium, Day 7	1.3	—
Sodium, Day 14	1.5	—
Sodium, Day 28	1.0	—
Sodium, Day 42	-1.0	—
Urea/BUN, Day 7	0.179	—
Urea/BUN, Day 14	0.178	—
Urea/BUN, Day 28	0.714	—
Urea/BUN, Day 42	-0.655	—
Cholesterol, Day 42	-0.052	—
Phosphorus inorganic, Day 7	-0.03	—
Phosphorus inorganic, Day 14	-0.10	—
Phosphorus inorganic, Day 28	-0.12	—
Phosphorus inorganic, Day 42	-0.05	—
Part C-GSK2890457+MetforminCalcium, Day 7	-0.004	—
Calcium, Day 14	0.017	—
Calcium, Day 28	0.035	—
Calcium, Day 42	-0.056	—
Chloride, Day 7	0.4	—
Chloride, Day 14	0.6	—
Chloride, Day 28	0.3	—
Chloride, Day 42	0.3	—
Carbon dioxide/Bicarbonate, Day 7	-0.6	—
Carbon dioxide/Bicarbonate, Day 14	-0.7	—
Carbon dioxide/Bicarbonate, Day 28	-0.3	—
Carbon dioxide/Bicarbonate, Day 42	-1.3	—
Glucose, Day 7	-1.7	—
Glucose, Day 14	-2.2	—
Glucose, Day 28	-2.0	—
Glucose, Day 42	0.1	—
Potassium, Day 7	0.06	—
Potassium, Day 14	0.07	—
Potassium, Day 28	-0.07	—
Potassium, Day 42	0.08	—
Magnesium, Day 7	-0.0206	—
Magnesium, Day 14	0.0206	—
Magnesium, Day 28	0.0240	—
Magnesium, Day 42	-0.0171	—
Sodium, Day 7	0.8	—
Sodium, Day 14	1.5	—
Sodium, Day 28	0.6	—
Sodium, Day 42	-1.0	—
Urea/BUN, Day 7	-0.208	—
Urea/BUN, Day 14	-0.268	—
Urea/BUN, Day 28	0.863	—
Urea/BUN, Day 42	-0.387	—
Cholesterol, Day 42	-0.155	—
Phosphorus inorganic, Day 7	0.01	—
Phosphorus inorganic, Day 14	0.03	—
Phosphorus inorganic, Day 28	0.12	—
Phosphorus inorganic, Day 42	-0.00	—

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

componentsdirect bilirubin change, total bilirubin change, creatinine change, uric acid change

Posted result

Group	Value (mean), Micromoles (umol)/L	95% CI
Part A-PlaceboDirect bilirubin, Day 7	0.000	—
Direct bilirubin, Day 14	0.428	—
Direct bilirubin, Day 28	-0.428	—
Direct bilirubin, Day 42	-0.855	—
Total bilirubin, Day 7	0.000	—
Total bilirubin, Day 14	0.428	—
Total bilirubin, Day 28	1.283	—
Total bilirubin, Day 42	0.855	—
Creatinine, Day 7	2.2	—
Creatinine, Day 14	-4.4	—
Creatinine, Day 28	0.0	—
Creatinine, Day 42	-2.2	—
Uric acid, Day 7	-7.4	—
Uric acid, Day 14	-14.9	—
Uric acid, Day 28	-1.5	—
Uric acid, Day 42	-7.4	—
Part A-GSK2890457Direct bilirubin, Day 7	-0.311	—
Direct bilirubin, Day 14	-0.466	—
Direct bilirubin, Day 28	-0.855	—
Direct bilirubin, Day 42	-0.171	—
Total bilirubin, Day 7	-0.777	—
Total bilirubin, Day 14	-0.933	—
Total bilirubin, Day 28	-2.565	—
Total bilirubin, Day 42	0.513	—
Creatinine, Day 7	-6.4	—
Creatinine, Day 14	-4.8	—
Creatinine, Day 28	-7.1	—
Creatinine, Day 42	-8.8	—
Uric acid, Day 7	-10.3	—
Uric acid, Day 14	-17.8	—
Uric acid, Day 28	4.2	—
Uric acid, Day 42	-26.2	—

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), umol/L	95% CI
Part B-Placebo+LiraglutideDirect bilirubin, Day 7	0.542	—
Direct bilirubin, Day 14	0.314	—
Direct bilirubin, Day 28	0.513	—
Direct bilirubin, Day 42	0.599	—
Total bilirubin, Day 7	0.570	—
Total bilirubin, Day 14	-0.570	—
Total bilirubin, Day 28	-0.000	—
Total bilirubin, Day 42	-1.425	—
Creatinine, Day 7	4.6	—
Creatinine, Day 14	-0.1	—
Creatinine, Day 28	1.9	—
Creatinine, Day 42	-1.0	—
Uric acid, Day 7	15.9	—
Uric acid, Day 14	-11.9	—
Uric acid, Day 28	2.0	—
Uric acid, Day 42	-5.0	—
Part B-GSK2890457+LiraglutideDirect bilirubin, Day 7	-0.208	—
Direct bilirubin, Day 14	-0.305	—
Direct bilirubin, Day 28	-0.197	—
Direct bilirubin, Day 42	-0.197	—
Total bilirubin, Day 7	-0.855	—
Total bilirubin, Day 14	-0.611	—
Total bilirubin, Day 28	0.132	—
Total bilirubin, Day 42	0.263	—
Creatinine, Day 7	3.0	—
Creatinine, Day 14	4.2	—
Creatinine, Day 28	2.0	—
Creatinine, Day 42	-2.4	—
Uric acid, Day 7	25.1	—
Uric acid, Day 14	15.3	—
Uric acid, Day 28	16.9	—
Uric acid, Day 42	7.8	—
Part C-Placebo+MetforminDirect bilirubin, Day 7	-0.513	—
Direct bilirubin, Day 14	-0.086	—
Direct bilirubin, Day 28	-0.171	—
Direct bilirubin, Day 42	-0.200	—
Total bilirubin, Day 7	-3.705	—
Total bilirubin, Day 14	-0.855	—
Total bilirubin, Day 28	-0.855	—
Total bilirubin, Day 42	-0.285	—
Creatinine, Day 7	6.9	—
Creatinine, Day 14	5.7	—
Creatinine, Day 28	4.9	—
Creatinine, Day 42	0.6	—
Uric acid, Day 7	3.0	—
Uric acid, Day 14	-21.8	—
Uric acid, Day 28	-13.9	—
Uric acid, Day 42	9.9	—
Part C-GSK2890457+MetforminDirect bilirubin, Day 7	-0.200	—
Direct bilirubin, Day 14	-0.185	—
Direct bilirubin, Day 28	-0.014	—
Direct bilirubin, Day 42	-0.328	—
Total bilirubin, Day 7	0.000	—
Total bilirubin, Day 14	0.285	—
Total bilirubin, Day 28	0.998	—
Total bilirubin, Day 42	-0.428	—
Creatinine, Day 7	3.4	—
Creatinine, Day 14	4.6	—
Creatinine, Day 28	8.2	—
Creatinine, Day 42	-0.8	—
Uric acid, Day 7	9.9	—
Uric acid, Day 14	25.3	—
Uric acid, Day 28	34.7	—
Uric acid, Day 42	0.5	—

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), g/L	95% CI
Part A-PlaceboAlbumin, Day 7	0.0	—
Albumin, Day 14	2.0	—
Albumin, Day 28	2.5	—
Albumin, Day 42	2.5	—
Total protein, Day 7	-0.8	—
Total protein, Day 14	-0.3	—
Total protein, Day 28	1.0	—
Total protein, Day 42	0.8	—
Part A-GSK2890457Albumin, Day 7	-0.3	—
Albumin, Day 14	0.4	—
Albumin, Day 28	0.4	—
Albumin, Day 42	0.0	—
Total protein, Day 7	-2.1	—
Total protein, Day 14	-1.2	—
Total protein, Day 28	-2.2	—
Total protein, Day 42	-3.1	—

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), g/L	95% CI
Part B-Placebo+LiraglutideAlbumin, Day 7	2.0	—
Albumin, Day 14	2.7	—
Albumin, Day 28	1.8	—
Albumin, Day 42	0.0	—
Total protein, Day 7	3.0	—
Total protein, Day 14	4.0	—
Total protein, Day 28	3.2	—
Total protein, Day 42	0.5	—
Part B-GSK2890457+LiraglutideAlbumin, Day 7	3.1	—
Albumin, Day 14	2.6	—
Albumin, Day 28	2.8	—
Albumin, Day 42	0.4	—
Total protein, Day 7	2.9	—
Total protein, Day 14	2.7	—
Total protein, Day 28	3.2	—
Total protein, Day 42	-0.6	—
Part C-Placebo+MetforminAlbumin, Day 7	1.3	—
Albumin, Day 14	0.8	—
Albumin, Day 28	2.3	—
Albumin, Day 42	-0.8	—
Total protein, Day 7	1.0	—
Total protein, Day 14	1.7	—
Total protein, Day 28	2.8	—
Total protein, Day 42	-0.7	—
Part C-GSK2890457+MetforminAlbumin, Day 7	0.5	—
Albumin, Day 14	1.6	—
Albumin, Day 28	1.9	—
Albumin, Day 42	-1.3	—
Total protein, Day 7	1.1	—
Total protein, Day 14	2.2	—
Total protein, Day 28	3.1	—
Total protein, Day 42	-1.5	—

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of Amylase and Lipase the Double-blind Treatment Period of Part B of Study

Time frame:Baseline (Day -1) and Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Units (U)/L	95% CI
Part B-Placebo+LiraglutideAmylase, Day 42	6.0	—
Lipase, Day 42	7.5	—
Part B-GSK2890457+LiraglutideAmylase, Day 42	9.2	—
Lipase, Day 42	18.8	—

Primary/registry result

Change From Baseline in Clinical Chemistry Parameter of Triiodothyronine (T3) Uptake During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Ratio	95% CI
Part B-Placebo+Liraglutide	-0.018	—
Part B-GSK2890457+Liraglutide	-0.009	—
Part C-Placebo+Metformin	0.002	—
Part C-GSK2890457+Metformin	-0.001	—

Primary/registry result/low confidence

Change From Baseline in Clinical Chemistry Parameters of Total Thyroxine and Total T3 During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

change from baseline, descriptive

componentstotal thyroxine change, total t3 change

Posted result

Group	Value (mean), Nanomoles (nmol)/L	95% CI
Part B-Placebo+LiraglutideTotal thyroxine	0.8578	—
Total T3	-0.3	—
Part B-GSK2890457+LiraglutideTotal thyroxine	1.0891	—
Total T3	0.1	—
Part C-Placebo+MetforminTotal thyroxine	-5.1478	—
Total T3	-0.2	—
Part C-GSK2890457+MetforminTotal thyroxine	-2.3597	—
Total T3	-0.2	—

Primary/registry result

Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), Milliunits (mu/L)	95% CI
Part B-GSK2890457+LiraglutideDay 7	-5.790	—
Day 42	-0.067	—
Part B-Placebo+LiraglutideDay 42	0.137	—
Part C-Placebo+MetforminDay 42	-0.187	—
Part C-GSK2890457+MetforminDay 42	0.149	—

Primary/registry result

Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Giga cells (GI)/L	95% CI
Part A-PlaceboBasophils, Day 7	0.00	—
Basophils, Day 14	-0.03	—
Basophils, Day 28	0.00	—
Basophils, Day 42	0.00	—
Eosinophils, Day 7	-0.03	—
Eosinophils, Day 14	-0.03	—
Eosinophils, Day 28	0.10	—
Eosinophils, Day 42	0.03	—
Lymphocytes, Day 7	-0.22	—
Lymphocytes, Day 14	-0.22	—
Lymphocytes, Day 28	-0.23	—
Lymphocytes, Day 42	0.15	—
Monocytes, Day 7	-0.08	—
Monocytes, Day 14	-0.10	—
Monocytes, Day 28	-0.05	—
Monocytes, Day 42	-0.05	—
Total Neutrophils, Day 7	0.15	—
Total Neutrophils, Day 14	0.50	—
Total Neutrophils, Day 28	-0.32	—
Total Neutrophils, Day 42	0.48	—
Platelet count, Day 7	-4.8	—
Platelet count, Day 14	-14.0	—
Platelet count, Day 28	-11.5	—
Platelet count, Day 42	-8.8	—
WBC count, Day 7	-0.15	—
WBC count, Day 14	0.18	—
WBC count, Day 28	-0.50	—
WBC count, Day 42	0.65	—
Part A-GSK2890457Basophils, Day 7	0.00	—
Basophils, Day 14	0.01	—
Basophils, Day 28	0.00	—
Basophils, Day 42	0.00	—
Eosinophils, Day 7	-0.03	—
Eosinophils, Day 14	0.00	—
Eosinophils, Day 28	0.00	—
Eosinophils, Day 42	0.00	—
Lymphocytes, Day 7	-0.01	—
Lymphocytes, Day 14	-0.06	—
Lymphocytes, Day 28	-0.32	—
Lymphocytes, Day 42	0.05	—
Monocytes, Day 7	-0.05	—
Monocytes, Day 14	-0.05	—
Monocytes, Day 28	0.01	—
Monocytes, Day 42	-0.06	—
Total Neutrophils, Day 7	0.02	—
Total Neutrophils, Day 14	-0.13	—
Total Neutrophils, Day 28	0.14	—
Total Neutrophils, Day 42	-0.01	—
Platelet count, Day 7	-1.9	—
Platelet count, Day 14	3.8	—
Platelet count, Day 28	9.7	—
Platelet count, Day 42	3.1	—
WBC count, Day 7	-0.11	—
WBC count, Day 14	-0.15	—
WBC count, Day 28	-0.16	—
WBC count, Day 42	-0.01	—

Primary/registry result

Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), GI/L	95% CI
Part B-Placebo+LiraglutideBasophils, Day 7	0.0270	—
Basophils, Day 14	0.0037	—
Basophils, Day 28	-0.0002	—
Basophils, Day 42	0.0098	—
Eosinophils, Day 7	0.02	—
Eosinophils, Day 14	0.01	—
Eosinophils, Day 28	0.01	—
Eosinophils, Day 42	0.01	—
Lymphocytes, Day 7	0.31	—
Lymphocytes, Day 14	0.18	—
Lymphocytes, Day 28	0.08	—
Lymphocytes, Day 42	0.02	—
Monocytes, Day 7	0.04	—
Monocytes, Day 14	-0.05	—
Monocytes, Day 28	0.03	—
Monocytes, Day 42	0.00	—
Total Neutrophils, Day 7	0.27	—
Total Neutrophils, Day 14	0.38	—
Total Neutrophils, Day 28	-0.01	—
Total Neutrophils, Day 42	-0.24	—
Platelet count, Day 7	18.3	—
Platelet count, Day 14	12.8	—
Platelet count, Day 28	4.5	—
Platelet count, Day 42	-2.0	—
WBC count, Day 7	0.65	—
WBC count, Day 14	0.52	—
WBC count, Day 28	0.08	—
WBC count, Day 42	-0.20	—
Part B-GSK2890457+LiraglutideBasophils, Day 7	0.0047	—
Basophils, Day 14	0.0041	—
Basophils, Day 28	0.0050	—
Basophils, Day 42	0.0019	—
Eosinophils, Day 7	0.04	—
Eosinophils, Day 14	0.03	—
Eosinophils, Day 28	0.02	—
Eosinophils, Day 42	0.06	—
Lymphocytes, Day 7	0.11	—
Lymphocytes, Day 14	0.04	—
Lymphocytes, Day 28	0.05	—
Lymphocytes, Day 42	-0.11	—
Monocytes, Day 7	-0.01	—
Monocytes, Day 14	-0.04	—
Monocytes, Day 28	-0.03	—
Monocytes, Day 42	-0.06	—
Total Neutrophils, Day 7	-0.13	—
Total Neutrophils, Day 14	-0.19	—
Total Neutrophils, Day 28	-0.17	—
Total Neutrophils, Day 42	-0.14	—
Platelet count, Day 7	8.9	—
Platelet count, Day 14	7.0	—
Platelet count, Day 28	10.8	—
Platelet count, Day 42	-13.2	—
WBC count, Day 7	-0.01	—
WBC count, Day 14	-0.17	—
WBC count, Day 28	-0.13	—
WBC count, Day 42	-0.26	—
Part C-Placebo+MetforminBasophils, Day 7	0.0047	—
Basophils, Day 14	-0.0015	—
Basophils, Day 28	-0.0065	—
Basophils, Day 42	-0.0190	—
Eosinophils, Day 7	-0.01	—
Eosinophils, Day 14	-0.02	—
Eosinophils, Day 28	0.01	—
Eosinophils, Day 42	-0.02	—
Lymphocytes, Day 7	0.09	—
Lymphocytes, Day 14	0.08	—
Lymphocytes, Day 28	0.05	—
Lymphocytes, Day 42	-0.11	—
Monocytes, Day 7	0.01	—
Monocytes, Day 14	0.06	—
Monocytes, Day 28	0.06	—
Monocytes, Day 42	-0.00	—
Total Neutrophils, Day 7	-0.54	—
Total Neutrophils, Day 14	-0.27	—
Total Neutrophils, Day 28	-0.48	—
Total Neutrophils, Day 42	-0.50	—
Platelet count, Day 7	5.0	—
Platelet count, Day 14	1.2	—
Platelet count, Day 28	0.5	—
Platelet count, Day 42	-13.8	—
WBC count, Day 7	-0.43	—
WBC count, Day 14	-0.13	—
WBC count, Day 28	-0.35	—
WBC count, Day 42	-0.62	—
Part C-GSK2890457+MetforminBasophils, Day 7	-0.0078	—
Basophils, Day 14	-0.0066	—
Basophils, Day 28	-0.0068	—
Basophils, Day 42	-0.0122	—
Eosinophils, Day 7	-0.03	—
Eosinophils, Day 14	-0.00	—
Eosinophils, Day 28	-0.00	—
Eosinophils, Day 42	-0.01	—
Lymphocytes, Day 7	0.14	—
Lymphocytes, Day 14	0.18	—
Lymphocytes, Day 28	0.25	—
Lymphocytes, Day 42	-0.07	—
Monocytes, Day 7	0.00	—
Monocytes, Day 14	0.06	—
Monocytes, Day 28	0.03	—
Monocytes, Day 42	-0.03	—
Total Neutrophils, Day 7	0.38	—
Total Neutrophils, Day 14	0.64	—
Total Neutrophils, Day 28	0.36	—
Total Neutrophils, Day 42	-0.10	—
Platelet count, Day 7	5.8	—
Platelet count, Day 14	12.9	—
Platelet count, Day 28	10.4	—
Platelet count, Day 42	-15.3	—
WBC count, Day 7	0.48	—
WBC count, Day 14	0.88	—
WBC count, Day 28	0.63	—
WBC count, Day 42	-0.22	—

Primary/registry result

Change From Baseline in Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

componentshemoglobin, mean corpuscular hemoglobin concentration

Posted result

Group	Value (mean), g/L	95% CI
Part A-PlaceboHemoglobin, Day 7	0.8	—
Hemoglobin, Day 14	4.0	—
Hemoglobin, Day 28	11.3	—
Hemoglobin, Day 42	9.8	—
MCHC, Day 7	1.8	—
MCHC, Day 14	-0.5	—
MCHC, Day 28	8.5	—
MCHC, Day 42	17.5	—
Part A-GSK2890457Hemoglobin, Day 7	-2.0	—
Hemoglobin, Day 14	-0.9	—
Hemoglobin, Day 28	0.5	—
Hemoglobin, Day 42	0.9	—
MCHC, Day 7	5.4	—
MCHC, Day 14	0.0	—
MCHC, Day 28	6.3	—
MCHC, Day 42	9.0	—

Primary/registry result

Change From Baseline in Hematology Parameters of Hemoglobin and MCHC During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), g/L	95% CI
Part B-Placebo+LiraglutideHemoglobin, Day 7	0.2	—
Hemoglobin, Day 14	0.2	—
Hemoglobin, Day 28	0.3	—
Hemoglobin, Day 42	0.0	—
MCHC, Day 7	-2.0	—
MCHC, Day 14	2.0	—
MCHC, Day 28	1.7	—
MCHC, Day 42	2.0	—
Part B-GSK2890457+LiraglutideHemoglobin, Day 7	-1.0	—
Hemoglobin, Day 14	-1.1	—
Hemoglobin, Day 28	-1.1	—
Hemoglobin, Day 42	-0.8	—
MCHC, Day 7	-4.1	—
MCHC, Day 14	-3.8	—
MCHC, Day 28	-1.9	—
MCHC, Day 42	0.2	—
Part C-Placebo+MetforminHemoglobin, Day 7	-4.3	—
Hemoglobin, Day 14	1.7	—
Hemoglobin, Day 28	-1.2	—
Hemoglobin, Day 42	-2.8	—
MCHC, Day 7	-4.5	—
MCHC, Day 14	-1.2	—
MCHC, Day 28	-2.0	—
MCHC, Day 42	-0.2	—
Part C-GSK2890457+MetforminHemoglobin, Day 7	-3.4	—
Hemoglobin, Day 14	-2.1	—
Hemoglobin, Day 28	-0.3	—
Hemoglobin, Day 42	-4.8	—
MCHC, Day 7	-2.8	—
MCHC, Day 14	-2.6	—
MCHC, Day 28	-1.4	—
MCHC, Day 42	0.8	—

Primary/registry result

Change From Baseline in Hematology Parameters of Red Blood Cell (RBC) Count and Reticulocytes During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

componentsrbc count, reticulocytes

Posted result

Group	Value (mean), Trillion cells (TI)/L	95% CI
Part A-PlaceboRBC count, Day 7	-0.008	—
RBC count, Day 14	0.090	—
RBC count, Day 28	0.258	—
RBC count, Day 42	0.107	—
Reticulocytes, Day 7	0.0115	—
Reticulocytes, Day 14	0.0077	—
Reticulocytes, Day 28	0.0073	—
Reticulocytes, Day 42	0.0022	—
Part A-GSK2890457RBC count, Day 7	-0.116	—
RBC count, Day 14	-0.084	—
RBC count, Day 28	-0.045	—
RBC count, Day 42	-0.115	—
Reticulocytes, Day 7	0.0014	—
Reticulocytes, Day 14	-0.0017	—
Reticulocytes, Day 28	0.0071	—
Reticulocytes, Day 42	0.0044	—

Primary/registry result

Change From Baseline in Hematology Parameters of RBC Count and Reticulocytes During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

componentsrbc count change, reticulocytes change

Posted result

Group	Value (mean), TI/L	95% CI
Part B-Placebo+LiraglutideRBC count, Day 7	0.018	—
RBC count, Day 14	-0.030	—
RBC count, Day 28	0.002	—
RBC count, Day 42	0.032	—
Reticulocytes, Day 7	0.0020	—
Reticulocytes, Day 14	-0.0019	—
Reticulocytes, Day 28	0.0029	—
Reticulocytes, Day 42	0.0062	—
Part B-GSK2890457+LiraglutideRBC count, Day 7	0.004	—
RBC count, Day 14	-0.011	—
RBC count, Day 28	-0.023	—
RBC count, Day 42	-0.031	—
Reticulocytes, Day 7	-0.0003	—
Reticulocytes, Day 14	0.0095	—
Reticulocytes, Day 28	0.0035	—
Reticulocytes, Day 42	0.0096	—
Part C-Placebo+MetforminRBC count, Day 7	-0.107	—
RBC count, Day 14	0.093	—
RBC count, Day 28	0.020	—
RBC count, Day 42	-0.053	—
Reticulocytes, Day 7	-0.0210	—
Reticulocytes, Day 14	-0.0286	—
Reticulocytes, Day 28	-0.0304	—
Reticulocytes, Day 42	-0.0200	—
Part C-GSK2890457+MetforminRBC count, Day 7	-0.085	—
RBC count, Day 14	-0.072	—
RBC count, Day 28	-0.003	—
RBC count, Day 42	-0.168	—
Reticulocytes, Day 7	-0.0015	—
Reticulocytes, Day 14	0.0147	—
Reticulocytes, Day 28	-0.0052	—
Reticulocytes, Day 42	-0.0042	—

Primary/registry result

Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Ratio	95% CI
Part A-PlaceboDay 7	0.0000	—
Day 14	0.0128	—
Day 28	0.0228	—
Day 42	0.0060	—
Part A-GSK2890457Day 7	-0.0128	—
Day 14	-0.0026	—
Day 28	-0.0066	—
Day 42	-0.0089	—

Primary/registry result

Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Ratio	95% CI
Part B-Placebo+LiraglutideDay 7	0.0032	—
Day 14	-0.0028	—
Day 28	-0.0003	—
Day 42	-0.0022	—
Part B-GSK2890457+LiraglutideDay 7	0.0019	—
Day 14	0.0011	—
Day 28	-0.0003	—
Day 42	-0.0025	—
Part C-Placebo+MetforminDay 7	-0.0082	—
Day 14	0.0057	—
Day 28	-0.0010	—
Day 42	-0.0087	—
Part C-GSK2890457+MetforminDay 7	-0.0072	—
Day 14	-0.0036	—
Day 28	0.0003	—
Day 42	-0.0159	—

Primary/registry result

Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Picograms	95% CI
Part A-PlaceboDay 7	0.25	—
Day 14	0.27	—
Day 28	0.70	—
Day 42	1.40	—
Part A-GSK2890457Day 7	0.31	—
Day 14	0.32	—
Day 28	0.37	—
Day 42	0.89	—

Primary/registry result

Change From Baseline in Hematology Parameter of MCH During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Picograms	95% CI
Part B-Placebo+LiraglutideDay 7	-0.02	—
Day 14	0.18	—
Day 28	0.17	—
Day 42	-0.12	—
Part B-GSK2890457+LiraglutideDay 7	-0.21	—
Day 14	-0.10	—
Day 28	0.01	—
Day 42	0.08	—
Part C-Placebo+MetforminDay 7	-0.23	—
Day 14	-0.25	—
Day 28	-0.20	—
Day 42	-0.28	—
Part C-GSK2890457+MetforminDay 7	-0.18	—
Day 14	0.03	—
Day 28	-0.08	—
Day 42	0.02	—

Primary/registry result

Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Femtoliters	95% CI
Part A-PlaceboDay 7	0.15	—
Day 14	0.85	—
Day 28	-0.30	—
Day 42	-0.90	—
Part A-GSK2890457Day 7	-0.55	—
Day 14	0.95	—
Day 28	-0.62	—
Day 42	0.35	—

Primary/registry result

Change From Baseline in Hematology Parameter of MCV During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Posted result

Group	Value (mean), Femtoliters	95% CI
Part B-Placebo+LiraglutideDay 7	0.35	—
Day 14	0.02	—
Day 28	0.05	—
Day 42	-0.90	—
Part B-GSK2890457+LiraglutideDay 7	0.39	—
Day 14	0.54	—
Day 28	0.55	—
Day 42	0.07	—
Part C-Placebo+MetforminDay 7	0.40	—
Day 14	-0.47	—
Day 28	-0.18	—
Day 42	-0.78	—
Part C-GSK2890457+MetforminDay 7	0.25	—
Day 14	0.76	—
Day 28	0.17	—
Day 42	-0.27	—

Primary/registry result

Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part A

Time frame:Up to Day 42

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Part A-PlaceboProtein, Trace, Day 1	1	—
Protein, Trace, Day 7	0	—
Protein, 1+, Day 7	0	—
Protein, Trace, Day 14	0	—
Protein, Trace, Day 28	1	—
Protein, Trace, Day 42	2	—
Bacteria, Rare, Day 1	1	—
Bacteria, Rare, Day 42	0	—
Bacteria, Moderate, Day 42	1	—
Occult blood, Trace, Day 1	1	—
Occult blood, Trace, Day 14	1	—
Occult blood, Trace, Day 28	0	—
Ketones, 1+, Day 1	1	—
Ketones, 1+, Day 7	0	—
Ketones, Trace, Day 14	1	—
Ketones, Trace, Day 28	1	—
Ketones, Trace, Day 42	1	—
RBC's, 1, Day 1	1	—
RBC's, 3, Day 1	1	—
RBC's, <1, Day 1	0	—
RBC's, 1, Day 7	0	—
RBC's, <1, Day 7	0	—
RBC's, 2, Day 14	1	—
RBC's, <1, Day 14	0	—
RBC's, 1, Day 28	0	—
RBC's, <1, Day 28	2	—
RBC's, 1, Day 42	0	—
RBC's, 2, Day 42	2	—
RBC's, <1, Day 42	0	—
WBC's, 1, Day 1	2	—
WBC's, <1, Day 1	0	—
WBC's, 1, Day 7	0	—
WBC's, <1, Day 7	0	—
WBC's, 2, Day 14	1	—
WBC's, <1, Day 14	1	—
WBC's, 1, Day 28	2	—
WBC's, <1, Day 28	0	—
WBC's, 1, Day 42	0	—
WBC's, 2, Day 42	1	—
WBC's, 4, Day 42	1	—
Part A-GSK2890457Protein, Trace, Day 1	3	—
Protein, Trace, Day 7	2	—
Protein, 1+, Day 7	1	—
Protein, Trace, Day 14	1	—
Protein, Trace, Day 28	4	—
Protein, Trace, Day 42	2	—
Bacteria, Rare, Day 1	0	—
Bacteria, Rare, Day 42	1	—
Bacteria, Moderate, Day 42	0	—
Occult blood, Trace, Day 1	0	—
Occult blood, Trace, Day 14	1	—
Occult blood, Trace, Day 28	1	—
Ketones, 1+, Day 1	0	—
Ketones, 1+, Day 7	1	—
Ketones, Trace, Day 14	0	—
Ketones, Trace, Day 28	0	—
Ketones, Trace, Day 42	0	—
RBC's, 1, Day 1	1	—
RBC's, 3, Day 1	0	—
RBC's, <1, Day 1	1	—
RBC's, 1, Day 7	1	—
RBC's, <1, Day 7	1	—
RBC's, 2, Day 14	0	—
RBC's, <1, Day 14	2	—
RBC's, 1, Day 28	2	—
RBC's, <1, Day 28	2	—
RBC's, 1, Day 42	1	—
RBC's, 2, Day 42	0	—
RBC's, <1, Day 42	1	—
WBC's, 1, Day 1	2	—
WBC's, <1, Day 1	1	—
WBC's, 1, Day 7	2	—
WBC's, <1, Day 7	1	—
WBC's, 2, Day 14	1	—
WBC's, <1, Day 14	1	—
WBC's, 1, Day 28	0	—
WBC's, <1, Day 28	1	—
WBC's, 1, Day 42	1	—
WBC's, 2, Day 42	0	—
WBC's, 4, Day 42	1	—

Primary/registry result

Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part B

Time frame:Up to Day 42

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Part B-Placebo+LiraglutideBacteria, Few, Day -1	1	—
Occult Blood, 1+, Day 14	0	—
Occult Blood, Trace, Day 28	0	—
Occult Blood, Trace, Day 42	0	—
Epithelial Cells, 10-20, Day -1	1	—
Epithelial Cells, 0-5, Day 7	1	—
Epithelial Cells, 6-10, Day 7	1	—
Epithelial Cells, 0-5, Day 14	1	—
Epithelial Cells, 0-5, Day 42	1	—
Glucose, 1+, Day -1	0	—
Glucose, 3+, Day -1	0	—
Glucose, Trace, Day -1	2	—
Glucose, 1+, Day 7	0	—
Glucose, 3+, Day 7	1	—
Glucose, Trace, Day 7	0	—
Glucose, 1+, Day 14	0	—
Glucose, 2+, Day 14	0	—
Glucose, 3+, Day 14	1	—
Glucose, Trace, Day 14	0	—
Glucose, 1+, Day 28	0	—
Glucose, 2+, Day 28	1	—
Glucose, 3+, Day 28	0	—
Glucose, Trace, Day 28	0	—
Glucose, 1+, Day 42	2	—
Glucose, 2+, Day 42	0	—
Glucose, 3+, Day 42	0	—
Glucose, Trace, Day 42	1	—
Hyaline Casts, 0-5, Day 14	1	—
Ketones, 1+, Day 7	0	—
Ketones, Trace, Day 14	2	—
Ketones, Trace, Day 28	0	—
RBC's, 0-3, Day-1	1	—
RBC's, 0-3, Day 7	1	—
RBC's, 0-3, Day 14	0	—
RBC's, 0-3, Day 28	0	—
RBC's, 0-3, Day 42	0	—
WBC's, 20-40, Day -1	1	—
WBC's, 0-5, Day 7	1	—
WBC's, 6-10, Day 7	1	—
WBC's, 0-5, Day 14	1	—
WBC's, 0-5, Day 28	0	—
WBC's, 0-5, Day 42	1	—
Part B-GSK2890457+LiraglutideBacteria, Few, Day -1	0	—
Occult Blood, 1+, Day 14	1	—
Occult Blood, Trace, Day 28	1	—
Occult Blood, Trace, Day 42	1	—
Epithelial Cells, 10-20, Day -1	0	—
Epithelial Cells, 0-5, Day 7	1	—
Epithelial Cells, 6-10, Day 7	0	—
Epithelial Cells, 0-5, Day 14	2	—
Epithelial Cells, 0-5, Day 42	1	—
Glucose, 1+, Day -1	4	—
Glucose, 3+, Day -1	2	—
Glucose, Trace, Day -1	1	—
Glucose, 1+, Day 7	1	—
Glucose, 3+, Day 7	2	—
Glucose, Trace, Day 7	3	—
Glucose, 1+, Day 14	1	—
Glucose, 2+, Day 14	1	—
Glucose, 3+, Day 14	1	—
Glucose, Trace, Day 14	3	—
Glucose, 1+, Day 28	2	—
Glucose, 2+, Day 28	1	—
Glucose, 3+, Day 28	2	—
Glucose, Trace, Day 28	1	—
Glucose, 1+, Day 42	0	—
Glucose, 2+, Day 42	2	—
Glucose, 3+, Day 42	3	—
Glucose, Trace, Day 42	3	—
Hyaline Casts, 0-5, Day 14	0	—
Ketones, 1+, Day 7	1	—
Ketones, Trace, Day 14	1	—
Ketones, Trace, Day 28	1	—
RBC's, 0-3, Day-1	0	—
RBC's, 0-3, Day 7	0	—
RBC's, 0-3, Day 14	1	—
RBC's, 0-3, Day 28	1	—
RBC's, 0-3, Day 42	1	—
WBC's, 20-40, Day -1	0	—
WBC's, 0-5, Day 7	1	—
WBC's, 6-10, Day 7	0	—
WBC's, 0-5, Day 14	1	—
WBC's, 0-5, Day 28	1	—
WBC's, 0-5, Day 42	1	—

Primary/registry result

Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part C

Time frame:Up to Day 42

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Part C-Placebo+MetforminProtein, 1+, Day 7	0	—
Protein, Trace, Day 7	0	—
Protein, Trace, Day 14	1	—
Protein, 1+, Day 28	0	—
Bacteria, Few, Day -1	0	—
Bacteria, Many, Day -1	1	—
Bacteria, Few, Day 7	0	—
Bacteria, Many, Day 7	1	—
Bacteria, Many, Day 14	0	—
Bacteria, Moderate, Day 14	1	—
Bacteria, Few, Day 28	1	—
Bacteria, Many, Day 28	1	—
Bacteria, Many, Day 42	1	—
Bacteria, Moderate, Day 42	0	—
Occult Blood, Trace, Day 42	0	—
Epithelial Cells, 0-10, Day -1	0	—
Epithelial Cells, 0-10, Day 7	0	—
Epithelial Cells, 0-5, Day 7	0	—
Epithelial Cells, 6-10, Day 7	0	—
Epithelial Cells, 0-5, Day 14	0	—
Epithelial Cells, >10, Day 14	0	—
Epithelial Cells, 0-10, Day 28	1	—
Epithelial Cells, 0-10, Day 42	0	—
Glucose, 1+, Day -1	0	—
Glucose, 2+, Day -1	0	—
Glucose, 3+, Day -1	0	—
Glucose, 1+, Day 7	1	—
Glucose, 2+, Day 7	0	—
Glucose, 3+, Day 7	1	—
Glucose, Trace, Day 7	1	—
Glucose, 1+, Day 14	1	—
Glucose, 3+, Day 14	0	—
Glucose, Trace, Day 14	0	—
Glucose, 2+, Day 28	1	—
Glucose, 3+, Day 28	1	—
Glucose, Trace, Day 28	0	—
Glucose, 1+, Day 42	3	—
Glucose, 2+, Day 42	0	—
Glucose, 3+, Day 42	0	—
Glucose, Trace, Day 42	0	—
Hyaline Casts, 0-1, Day 7	0	—
Ketones, 1+, Day 7	0	—
Ketones, Trace, Day 7	0	—
Ketones, Trace, Day 14	1	—
Ketones, Trace, Day 28	1	—
RBC's, 0-3, Day -1	0	—
RBC's, 0-3, Day 7	0	—
RBC's, 0-3, Day 14	0	—
RBC's, 0-3, Day 28	1	—
RBC's, 0-3, Day 42	0	—
Uric acid crystals, Moderate, Day 7	0	—
Uric acid crystals, Few, Day 14	0	—
WBC's, 0-5, Day -1	1	—
WBC's, 0-5, Day 7	1	—
WBC's, 6-10, Day 7	0	—
WBC's, 0-5, Day 14	1	—
WBC's, 0-5, Day 28	1	—
WBC's, 40-60, Day 28	1	—
WBC's, 6-10, Day 42	1	—
Part C-GSK2890457+MetforminProtein, 1+, Day 7	1	—
Protein, Trace, Day 7	2	—
Protein, Trace, Day 14	1	—
Protein, 1+, Day 28	1	—
Bacteria, Few, Day -1	1	—
Bacteria, Many, Day -1	0	—
Bacteria, Few, Day 7	4	—
Bacteria, Many, Day 7	0	—
Bacteria, Many, Day 14	1	—
Bacteria, Moderate, Day 14	0	—
Bacteria, Few, Day 28	1	—
Bacteria, Many, Day 28	0	—
Bacteria, Many, Day 42	0	—
Bacteria, Moderate, Day 42	1	—
Occult Blood, Trace, Day 42	1	—
Epithelial Cells, 0-10, Day -1	1	—
Epithelial Cells, 0-10, Day 7	1	—
Epithelial Cells, 0-5, Day 7	1	—
Epithelial Cells, 6-10, Day 7	1	—
Epithelial Cells, 0-5, Day 14	1	—
Epithelial Cells, >10, Day 14	1	—
Epithelial Cells, 0-10, Day 28	1	—
Epithelial Cells, 0-10, Day 42	1	—
Glucose, 1+, Day -1	1	—
Glucose, 2+, Day -1	1	—
Glucose, 3+, Day -1	6	—
Glucose, 1+, Day 7	0	—
Glucose, 2+, Day 7	2	—
Glucose, 3+, Day 7	1	—
Glucose, Trace, Day 7	2	—
Glucose, 1+, Day 14	2	—
Glucose, 3+, Day 14	2	—
Glucose, Trace, Day 14	4	—
Glucose, 2+, Day 28	2	—
Glucose, 3+, Day 28	1	—
Glucose, Trace, Day 28	2	—
Glucose, 1+, Day 42	2	—
Glucose, 2+, Day 42	1	—
Glucose, 3+, Day 42	4	—
Glucose, Trace, Day 42	1	—
Hyaline Casts, 0-1, Day 7	1	—
Ketones, 1+, Day 7	1	—
Ketones, Trace, Day 7	2	—
Ketones, Trace, Day 14	1	—
Ketones, Trace, Day 28	1	—
RBC's, 0-3, Day -1	1	—
RBC's, 0-3, Day 7	2	—
RBC's, 0-3, Day 14	2	—
RBC's, 0-3, Day 28	1	—
RBC's, 0-3, Day 42	1	—
Uric acid crystals, Moderate, Day 7	1	—
Uric acid crystals, Few, Day 14	1	—
WBC's, 0-5, Day -1	1	—
WBC's, 0-5, Day 7	3	—
WBC's, 6-10, Day 7	1	—
WBC's, 0-5, Day 14	2	—
WBC's, 0-5, Day 28	1	—
WBC's, 40-60, Day 28	0	—
WBC's, 6-10, Day 42	1	—

Primary/registry result

Mean pH Values of Urine During the Double-blind Treatment Period of Part B and C

Time frame:Up to Day 42

descriptive

Posted result

Group	Value (mean), pH	95% CI
Part B-Placebo+LiraglutideDay -1	5.92	—
Day 7	5.83	—
Day 14	5.67	—
Day 28	5.75	—
Day 42	6.00	—
Part B-GSK2890457+LiraglutideDay -1	6.25	—
Day 7	5.89	—
Day 14	6.07	—
Day 28	5.96	—
Day 42	6.08	—
Part C-Placebo+MetforminDay -1	5.67	—
Day 7	5.83	—
Day 14	5.67	—
Day 28	5.67	—
Day 42	5.58	—
Part C-GSK2890457+MetforminDay -1	5.83	—
Day 7	5.42	—
Day 14	5.63	—
Day 28	5.63	—
Day 42	5.58	—

Primary/registry result

Change From Baseline in Electrocardiogram (ECG) Intervals During Part A

Time frame:Baseline (Day 1, Randomization) up to Follow-up (Day 56)

change from baseline, descriptive

Posted result

Group	Value (mean), Milliseconds	95% CI
Part A-PlaceboPR Interval, Day 42	6.3	—
PR Interval, Follow-up	9.0	—
QRS Duration, Day 42	2.2	—
QRS Duration, Follow-up	3.9	—
QT Interval, Day 42	10.8	—
QT Interval, Follow-up	0.3	—
QTcB, Day 42	8.2	—
QTcB, Follow-up	6.9	—
QTcF, Day 42	9.1	—
QTcF, Follow-up	4.8	—
Part A-GSK2890457PR Interval, Day 42	1.1	—
PR Interval, Follow-up	1.5	—
QRS Duration, Day 42	-2.1	—
QRS Duration, Follow-up	-0.7	—
QT Interval, Day 42	16.4	—
QT Interval, Follow-up	-10.2	—
QTcB, Day 42	-3.3	—
QTcB, Follow-up	6.3	—
QTcF, Day 42	3.2	—
QTcF, Follow-up	0.7	—

Primary/registry result

Change From Baseline in ECG Intervals During Part B and C

Time frame:Baseline (Day -1) up to Follow-up (Day 56)

change from baseline, descriptive

componentsecg pr interval, ecg qrs duration, ecg qt interval, ecg qtc bazett, ecg qtc fridericia, ecg rr interval

Posted result

Group	Value (mean), Milliseconds	95% CI
Part B-Placebo+LiraglutidePR Interval, Day 42	5.56	—
PR Interval, Follow-up	-1.11	—
QRS Duration, Day 42	0.78	—
QRS Duration, Follow-up	0.11	—
QT Interval, Day 42	8.11	—
QT Interval, Follow-up	1.44	—
QTcB, Day 42	-2.87	—
QTcB, Follow-up	-5.89	—
QTcF, Day 42	1.17	—
QTcF, Follow-up	-3.17	—
RR Interval, Day 42	0.04	—
RR Interval, Follow-up	0.03	—
Part B-GSK2890457+LiraglutidePR Interval, Day 42	3.08	—
PR Interval, Follow-up	-3.69	—
QRS Duration, Day 42	-2.62	—
QRS Duration, Follow-up	-1.69	—
QT Interval, Day 42	-1.69	—
QT Interval, Follow-up	-5.69	—
QTcB, Day 42	-1.51	—
QTcB, Follow-up	-10.95	—
QTcF, Day 42	-1.49	—
QTcF, Follow-up	-9.10	—
RR Interval, Day 42	-0.00	—
RR Interval, Follow-up	0.02	—
Part C-Placebo+MetforminPR Interval, Day 42	-6.44	—
PR Interval, Follow-up	-3.11	—
QRS Duration, Day 42	0.11	—
QRS Duration, Follow-up	0.78	—
QT Interval, Day 42	2.78	—
QT Interval, Follow-up	0.78	—
QTcB, Day 42	0.43	—
QTcB, Follow-up	-3.20	—
QTcF, Day 42	1.22	—
QTcF, Follow-up	-1.78	—
RR Interval, Day 42	0.01	—
RR Interval, Follow-up	0.02	—
Part C-GSK2890457+MetforminPR Interval, Day 42	-4.44	—
PR Interval, Follow-up	-6.28	—
QRS Duration, Day 42	-1.06	—
QRS Duration, Follow-up	0.11	—
QT Interval, Day 42	0.78	—
QT Interval, Follow-up	-5.56	—
QTcB, Day 42	-4.23	—
QTcB, Follow-up	-2.14	—
QTcF, Day 42	-2.58	—
QTcF, Follow-up	-3.50	—
RR Interval, Day 42	0.02	—
RR Interval, Follow-up	-0.01	—

Primary/protocol endpoint

Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part A

Time frame:Up to Follow-up (8 weeks)

Serious AEs (any)

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint)

Primary/protocol endpoint

Number of Participants With Any AE, SAE or Death During Part B and Part C

Time frame:Up to Follow-up (8 weeks)

Treatment-emergent AEs (any)

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Death (safety endpoint)

Primary/protocol endpoint

Number of Participants With Any Hypoglycemic Events During Part A

Time frame:Up to Follow-up (8 weeks)

Documented hypoglycemia

event count, event

Primary/protocol endpoint

Number of Participants With Any Hypoglycemic Events During Part B and Part C

Time frame:Up to Follow-up (8 weeks)

Documented hypoglycemia

threshold achievement, event

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic and Urea/Blood Urea Nitrogen (BUN) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

componentselectrolytes panel, glucose, phosphorus inorganic, urea bun

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic, BUN and Cholesterol During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

componentsdirect bilirubin, total bilirubin, creatinine, uric acid

Primary/protocol endpoint/low confidence

Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

componentsdirect bilirubin change, total bilirubin change, creatinine change, uric acid change

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameters of Amylase and Lipase the Double-blind Treatment Period of Part B of Study

Time frame:Baseline (Day -1) and Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameter of Triiodothyronine (T3) Uptake During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameters of Total Thyroxine and Total T3 During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) and Day 42

Thyroid event

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Hematology Parameters of Hemoglobin and MCHC During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Hematology Parameters of Red Blood Cell (RBC) Count and Reticulocytes During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Hematology Parameters of RBC Count and Reticulocytes During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

componentsrbc count, reticulocytes

Primary/protocol endpoint

Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Hematology Parameter of MCH During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) During the Double-blind Treatment Period of Part A

Time frame:Baseline (Day 1, Randomization) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Change From Baseline in Hematology Parameter of MCV During the Double-blind Treatment Period of Part B and C

Time frame:Baseline (Day -1) up to Day 42

change from baseline, descriptive

Primary/protocol endpoint

Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part A

Time frame:Up to Day 42

descriptive

Primary/protocol endpoint

Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part B

Time frame:Up to Day 42

descriptive

Primary/protocol endpoint

Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part C

Time frame:Up to Day 42

descriptive

Primary/protocol endpoint

Change From Baseline in Electrocardiogram (ECG) Intervals During Part A

Time frame:Baseline (Day 1, Randomization) up to Follow-up (Day 56)

change from baseline, descriptive

componentsheart rate, pr interval, qrs duration, qt interval, qtcf interval, qtcb interval

Primary/protocol endpoint

Change From Baseline in ECG Intervals During Part B and C

Time frame:Baseline (Day -1) up to Follow-up (Day 56)

change from baseline, descriptive

Secondary/registry result

Area Under Plasma Concentration From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Liraglutide During the Double-blind Treatment Period of Part B

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), Hour*nanograms/mL	95% CI
Part B-Placebo+LiraglutideDay -1	2210.15	—
Day 42	2505.23	—
Part B-GSK2890457+LiraglutideDay -1	1268.65	—
Day 42	1265.92	—

Ratio1.046090% CI0.7290 – 1.5008Mixed Models Analysis

Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.

Secondary/registry result

Maximum Observed Concentration (Cmax) of Liraglutide During the Double-blind Treatment Period of Part B

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), Nanograms/mL	95% CI
Part B-Placebo+LiraglutideDay -1	120.00	—
Day 42	128.57	—
Part B-GSK2890457+LiraglutideDay -1	72.24	—
Day 42	70.86	—

Ratio1.033490% CI0.7810 – 1.3673Mixed Models Analysis

Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.

Secondary/registry result

Time of Occurrence of Cmax (Tmax) of Liraglutide During the Double-blind Treatment Period of Part B

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose

Tmax

descriptive

Posted result

Group	Value (median), Hours	95% CI
Part B-Placebo+LiraglutideDay -1	9.74	2.0 – 11.5
Day 42	9.92	2.1 – 11.5
Part B-GSK2890457+LiraglutideDay -1	8.00	0.0 – 11.5
Day 42	9.98	0.8 – 23.8

Secondary/registry result

AUC of Metformin From Time 0 to 10 Hours Post-dose (AUC [0-10 Hour]) During the Double-blind Treatment Period of Part A

Time frame:Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), Hour*nanograms/mL	95% CI
Part A-PlaceboDay 1	4346.8	—
Day 42	5081.9	—
Part A-GSK2890457Day 1	3402.6	—
Day 42	2231.7	—

Ratio0.67590% CI0.585 – 0.779Mixed Models Analysis

Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.

Secondary/registry result

Cmax of Metformin During the Double-blind Treatment Period of Part A

Time frame:Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), Nanograms/mL	95% CI
Part A-PlaceboDay 1	681.8	—
Day 42	860.1	—
Part A-GSK2890457Day 1	576.2	—
Day 42	374.1	—

Ratio0.66290% CI0.578 – 0.757Mixed Models Analysis

Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.

Secondary/registry result

Tmax of Metformin During the Double-blind Treatment Period of Part A

Time frame:Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose

Tmax

descriptive

Posted result

Group	Value (median), Hours	95% CI
Part A-PlaceboDay 1	3.010	2.00 – 4.03
Day 42	4.000	2.00 – 4.03
Part A-GSK2890457Day 1	2.000	1.00 – 4.00
Day 42	2.000	2.00 – 5.50

Secondary/registry result

AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Metformin During the Double-blind Treatment Period of Part C

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/registry result

Cmax of Metformin During the Double-blind Treatment Period of Part C

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose

Cmax

concentration, descriptive

Secondary/registry result

Tmax of Metformin During the Double-blind Treatment Period of Part C

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose

Tmax

descriptive

Secondary/protocol endpoint

Area Under Plasma Concentration From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Liraglutide During the Double-blind Treatment Period of Part B

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum Observed Concentration (Cmax) of Liraglutide During the Double-blind Treatment Period of Part B

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time of Occurrence of Cmax (Tmax) of Liraglutide During the Double-blind Treatment Period of Part B

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose

Tmax

descriptive

Secondary/protocol endpoint

AUC of Metformin From Time 0 to 10 Hours Post-dose (AUC [0-10 Hour]) During the Double-blind Treatment Period of Part A

Time frame:Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax of Metformin During the Double-blind Treatment Period of Part A

Time frame:Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Tmax of Metformin During the Double-blind Treatment Period of Part A

Time frame:Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose

Tmax

concentration, descriptive

Secondary/protocol endpoint

AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Metformin During the Double-blind Treatment Period of Part C

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax of Metformin During the Double-blind Treatment Period of Part C

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Tmax of Metformin During the Double-blind Treatment Period of Part C

Time frame:Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose

Tmax

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Mean pH Values of Urine During the Double-blind Treatment Period of Part B and C

Time frame:Up to Day 42

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Weight and Glucose Reduction Observed with a Combination of Nutritional Agents in Rodent Models Does Not Translate to Humans in a Randomized Clinical Trial with Healthy Volunteers and Subjects with Type 2 Diabetes.
PloS one2016 (year)PMID27093610doi:10.1371/journal.pone.0153151via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.