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Delfa

← All trials/NCT01725126

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

3

Recruiting sites

-

Actual enrollment

53

Study population

Healthy volunteers, Obesity / overweight, Type 2 diabetes

Eligibility highlights

•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

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. 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

Who this study enrolls

Healthy volunteersObesity / overweightType 2 diabetes

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
81
Glycemic / diabetes
18
Cardiometabolic biomarkers
8
Renal / kidney
6
Weight & body composition
4
MASH / liver
4
Patient-reported / QoL
4
Other (unclassified)
1

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

GroupMean · Kilograms (kg)95% CI
Part B-Placebo+LiraglutideDay 7-0.12-
Day 140.37-
Day 280.15-
Day 42-0.74-
Part B-GSK2890457+LiraglutideDay 70.20-
Day 140.05-
Day 280.47-
Day 42-0.39-
Part C-Placebo+MetforminDay 70.28-
Day 140.61-
Day 280.52-
Day 42-0.47-
Part C-GSK2890457+MetforminDay 70.47-
Day 140.56-
Day 280.27-
Day 420.42-
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

GroupMean · Percent change95% CI
Part B-Placebo+LiraglutideDay 7-0.16-
Day 140.47-
Day 280.25-
Day 42-0.80-
Part B-GSK2890457+LiraglutideDay 70.18-
Day 14-0.04-
Day 280.39-
Day 42-0.51-
Part C-Placebo+MetforminDay 70.36-
Day 140.79-
Day 280.66-
Day 42-0.53-
Part C-GSK2890457+MetforminDay 70.59-
Day 140.60-
Day 280.30-
Day 420.50-
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

GroupMean · Picomoles (pmol)/L95% CI
Part A-PlaceboDay 7-1.256-
Day 148.072-
Day 28-11.659-
Day 42-22.721-
Part A-GSK2890457Day 712.516-
Day 141.973-
Day 288.969-
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

GroupMean · pmol/L95% 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 745.11-
Day 14-79.39-
Day 2834.28-
Day 4234.28-
Part C-GSK2890457+MetforminDay 7-29.59-
Day 14-41.14-
Day 28-7.22-
Day 4235.28-
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

GroupLeast-squares mean · mmol/L95% 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

GroupLeast-squares mean · mmol/L95% CI
Part B-Placebo+Liraglutide-0.384-
Part B-GSK2890457+Liraglutide-0.230-
Part C-Placebo+Metformin0.136-
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

GroupMean · pmol/L95% CI
Part B-Placebo+LiraglutideFasting Insulin-4.887-
Insulin Weighted Mean AUC 0-4 hour69.635-
Insulin Weighted Mean AUC 0-24 hour1.626-
Part B-GSK2890457+LiraglutideFasting Insulin1.133-
Insulin Weighted Mean AUC 0-4 hour14.589-
Insulin Weighted Mean AUC 0-24 hour-13.905-
Part C-Placebo+MetforminFasting Insulin-11.946-
Insulin Weighted Mean AUC 0-4 hour57.887-
Insulin Weighted Mean AUC 0-24 hour22.740-
Part C-GSK2890457+MetforminFasting Insulin12.300-
Insulin Weighted Mean AUC 0-4 hour10.322-
Insulin Weighted Mean AUC 0-24 hour17.134-
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

GroupLeast-squares mean · Percent of TL hemoglobin95% CI
Part B-Placebo+Liraglutide-0.214-
Part B-GSK2890457+Liraglutide-0.278-
Part C-Placebo+Metformin0.018-
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

GroupMean · mU*mmol/L^295% CI
Part B-Placebo+Liraglutide-0.150-
Part B-GSK2890457+Liraglutide0.017-
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

GroupMean · Deciliter*mL/mg*mU95% 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

GroupMean · mmol/L95% CI
Part B-Placebo+LiraglutideDay 7-0.278-
Day 14-0.093-
Day 28-0.111-
Day 420.194-
Follow-up0.962-
Part B-GSK2890457+LiraglutideDay 70.285-
Day 140.210-
Day 28-0.201-
Day 42-0.098-
Follow-up0.444-
Part C-Placebo+MetforminDay 70.879-
Day 140.518-
Day 281.536-
Day 421.184-
Follow-up1.249-
Part C-GSK2890457+MetforminDay 7-1.665-
Day 14-2.216-
Day 28-1.989-
Day 420.074-
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

GroupMean · International unit per liter (IU/L)95% CI
Part A-PlaceboALP, Day 7-6.0-
ALP, Day 14-1.3-
ALP, Day 280.0-
ALP, Day 42-1.0-
ALT, Day 75.5-
ALT, Day 141.3-
ALT, Day 282.0-
ALT, Day 425.3-
AST, Day 72.3-
AST, Day 14-2.3-
AST, Day 28-0.8-
AST, Day 422.3-
GGT, Day 71.5-
GGT, Day 141.0-
GGT, Day 280.8-
GGT, Day 422.5-
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 141.4-
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

GroupMean · IU/L95% CI
Part B-Placebo+LiraglutideALP, Day 75.3-
ALP, Day 145.2-
ALP, Day 28-0.3-
ALP, Day 424.3-
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 70.7-
GGT, Day 140.8-
GGT, Day 280.0-
GGT, Day 42-0.7-
Part B-GSK2890457+LiraglutideALP, Day 75.5-
ALP, Day 141.8-
ALP, Day 282.8-
ALP, Day 422.2-
ALT, Day 7-0.1-
ALT, Day 140.6-
ALT, Day 280.9-
ALT, Day 421.0-
AST, Day 71.1-
AST, Day 141.9-
AST, Day 282.2-
AST, Day 423.8-
GGT, Day 7-1.2-
GGT, Day 14-1.4-
GGT, Day 280.8-
GGT, Day 420.2-
Part C-Placebo+MetforminALP, Day 71.8-
ALP, Day 146.7-
ALP, Day 286.3-
ALP, Day 420.5-
ALT, Day 71.5-
ALT, Day 143.0-
ALT, Day 280.7-
ALT, Day 42-0.5-
AST, Day 7-0.5-
AST, Day 14-1.0-
AST, Day 280.7-
AST, Day 421.0-
GGT, Day 70.3-
GGT, Day 145.3-
GGT, Day 282.3-
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 70.2-
AST, Day 14-0.3-
AST, Day 281.4-
AST, Day 421.9-
GGT, Day 71.3-
GGT, Day 142.3-
GGT, Day 280.5-
GGT, Day 42-0.9-
Primary/protocol endpoint

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

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

GroupMean · Ratio95% CI
Part A-PlaceboDay 11.0193-
Day 71.0133-
Day 141.0153-
Day 281.0125-
Day 421.0155-
Part A-GSK2890457Day 11.0175-
Day 71.0165-
Day 141.0152-
Day 281.0122-
Day 421.0161-
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

GroupMean · Ratio95% CI
Part B-Placebo+LiraglutideDay -11.0168-
Day 71.0208-
Day 141.0202-
Day 281.0232-
Day 421.0137-
Part B-GSK2890457+LiraglutideDay -11.0174-
Day 71.0191-
Day 141.0196-
Day 281.0239-
Day 421.0188-
Part C-Placebo+MetforminDay -11.0172-
Day 71.0197-
Day 141.0198-
Day 281.0213-
Day 421.0110-
Part C-GSK2890457+MetforminDay -11.0187-
Day 71.0208-
Day 141.0201-
Day 281.0213-
Day 421.0172-
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

GroupMean · pH95% CI
Part A-PlaceboDay 15.25-
Day 75.88-
Day 145.50-
Day 286.13-
Day 425.63-
Part A-GSK2890457Day 15.95-
Day 75.86-
Day 145.91-
Day 286.05-
Day 426.20-
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

GroupMean · Millimeters of mercury (mmHg)95% CI
Part A-PlaceboSBP, Day 70.8-
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

GroupMean · mmHg95% CI
Part B-Placebo+LiraglutideSBP, Day 71.6-
SBP, Day 145.6-
SBP, Day 28-0.6-
SBP, Day 42-2.6-
DBP, Day 7-2.4-
DBP, Day 142.1-
DBP, Day 28-3.3-
DBP, Day 42-1.5-
Part B-GSK2890457+LiraglutideSBP, Day 72.0-
SBP, Day 143.6-
SBP, Day 280.2-
SBP, Day 420.1-
DBP, Day 70.4-
DBP, Day 140.8-
DBP, Day 280.4-
DBP, Day 420.8-
Part C-Placebo+MetforminSBP, Day 73.2-
SBP, Day 143.2-
SBP, Day 284.5-
SBP, Day 420.0-
DBP, Day 70.9-
DBP, Day 14-0.8-
DBP, Day 28-0.4-
DBP, Day 421.1-
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

GroupMean · Beats per minute95% CI
Part A-PlaceboDay 78.0-
Day 146.3-
Day 285.5-
Day 42-1.3-
Part A-GSK2890457Day 74.6-
Day 140.6-
Day 283.3-
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

GroupMean · Beats per minute95% CI
Part B-Placebo+LiraglutideDay 7-3.6-
Day 14-3.3-
Day 28-7.8-
Day 42-4.8-
Part B-GSK2890457+LiraglutideDay 70.3-
Day 140.4-
Day 283.7-
Day 421.6-
Part C-Placebo+MetforminDay 70.1-
Day 140.8-
Day 281.8-
Day 42-3.2-
Part C-GSK2890457+MetforminDay 71.6-
Day 143.6-
Day 281.5-
Day 420.5-
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

GroupMean · Scores on scale95% CI
Part A-PlaceboDay 70.02-
Day 140.08-
Day 420.02-
Part A-GSK2890457Day 70.08-
Day 140.04-
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

GroupMean · Scores on scale95% CI
Part B-Placebo+LiraglutideDay 70.03-
Day 14-0.09-
Day 28-0.21-
Day 41-0.11-
Part B-GSK2890457+LiraglutideDay 7-0.03-
Day 140.05-
Day 280.03-
Day 41-0.12-
Part C-Placebo+MetforminDay 70.24-
Day 140.20-
Day 280.14-
Day 410.02-
Part C-GSK2890457+MetforminDay 70.13-
Day 140.28-
Day 280.27-
Day 410.10-
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

GroupParticipants95% CI
Part A-PlaceboAny AE3-
Any SAE0-
Any Death0-
Part A-GSK2890457Any AE10-
Any SAE0-
Any Death0-
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

GroupParticipants95% CI
Part B-Placebo+LiraglutideAny AE1-
Any SAE0-
Any Death0-
Part B-GSK2890457+LiraglutideAny AE3-
Any SAE0-
Any Death0-
Part C-Placebo+MetforminAny AE3-
Any SAE0-
Any Death0-
Part C-GSK2890457+MetforminAny AE3-
Any SAE0-
Any Death0-
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

GroupParticipants95% CI
Part A-Placebo0-
Part A-GSK28904570-
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

GroupParticipants95% CI
Part B-Placebo+Liraglutide0-
Part B-GSK2890457+Liraglutide0-
Part C-Placebo+Metformin0-
Part C-GSK2890457+Metformin0-
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

GroupMean · Millimoles (mmol)/L95% CI
Part A-PlaceboCalcium, Day 7-0.025-
Calcium, Day 140.056-
Calcium, Day 280.056-
Calcium, Day 420.050-
Chloride, Day 70.8-
Chloride, Day 141.0-
Chloride, Day 28-1.5-
Chloride, Day 42-0.8-
Carbon dioxide/Bicarbonate, Day 70.3-
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 70.15-
Potassium, Day 140.20-
Potassium, Day 28-0.07-
Potassium, Day 420.30-
Magnesium, Day 7-0.0206-
Magnesium, Day 14-0.0617-
Magnesium, Day 28-0.0411-
Magnesium, Day 42-0.0308-
Sodium, Day 70.3-
Sodium, Day 14-0.3-
Sodium, Day 281.0-
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 420.01-
Part A-GSK2890457Calcium, Day 7-0.023-
Calcium, Day 14-0.023-
Calcium, Day 28-0.010-
Calcium, Day 42-0.022-
Chloride, Day 71.2-
Chloride, Day 140.4-
Chloride, Day 280.5-
Chloride, Day 420.4-
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 70.8-
Sodium, Day 14-0.2-
Sodium, Day 281.9-
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

GroupMean · mmol/L95% CI
Part B-Placebo+LiraglutideCalcium, Day 70.083-
Calcium, Day 140.050-
Calcium, Day 280.021-
Calcium, Day 42-0.025-
Chloride, Day 7-1.5-
Chloride, Day 14-0.8-
Chloride, Day 280.8-
Chloride, Day 42-1.0-
Carbon dioxide/Bicarbonate, Day 70.0-
Carbon dioxide/Bicarbonate, Day 14-1.8-
Carbon dioxide/Bicarbonate, Day 28-1.0-
Carbon dioxide/Bicarbonate, Day 420.5-
Glucose, Day 7-0.3-
Glucose, Day 14-0.1-
Glucose, Day 28-0.1-
Glucose, Day 420.2-
Potassium, Day 70.33-
Potassium, Day 140.17-
Potassium, Day 280.28-
Potassium, Day 42-0.05-
Magnesium, Day 70.0206-
Magnesium, Day 14-0.0206-
Magnesium, Day 280.0274-
Magnesium, Day 42-0.0137-
Sodium, Day 71.2-
Sodium, Day 141.3-
Sodium, Day 281.8-
Sodium, Day 420.5-
Urea/BUN, Day 7-0.000-
Urea/BUN, Day 14-0.297-
Urea/BUN, Day 280.119-
Urea/BUN, Day 42-0.595-
Cholesterol, Day 42-0.853-
Phosphorus inorganic, Day 70.10-
Phosphorus inorganic, Day 140.01-
Phosphorus inorganic, Day 280.06-
Phosphorus inorganic, Day 420.01-
Part B-GSK2890457+LiraglutideCalcium, Day 70.053-
Calcium, Day 140.041-
Calcium, Day 280.046-
Calcium, Day 42-0.040-
Chloride, Day 7-1.2-
Chloride, Day 14-0.1-
Chloride, Day 280.2-
Chloride, Day 420.2-
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 70.3-
Glucose, Day 140.2-
Glucose, Day 28-0.2-
Glucose, Day 42-0.1-
Potassium, Day 70.09-
Potassium, Day 140.20-
Potassium, Day 280.08-
Potassium, Day 420.01-
Magnesium, Day 70.0294-
Magnesium, Day 140.0176-
Magnesium, Day 280.0379-
Magnesium, Day 420.0063-
Sodium, Day 70.2-
Sodium, Day 141.4-
Sodium, Day 281.7-
Sodium, Day 42-0.4-
Urea/BUN, Day 70.383-
Urea/BUN, Day 140.128-
Urea/BUN, Day 280.302-
Urea/BUN, Day 42-0.412-
Cholesterol, Day 42-0.103-
Phosphorus inorganic, Day 70.01-
Phosphorus inorganic, Day 140.05-
Phosphorus inorganic, Day 28-0.01-
Phosphorus inorganic, Day 42-0.04-
Part C-Placebo+MetforminCalcium, Day 70.025-
Calcium, Day 140.067-
Calcium, Day 280.004-
Calcium, Day 42-0.071-
Chloride, Day 70.8-
Chloride, Day 140.5-
Chloride, Day 281.0-
Chloride, Day 420.5-
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 70.9-
Glucose, Day 140.5-
Glucose, Day 281.5-
Glucose, Day 421.2-
Potassium, Day 70.28-
Potassium, Day 140.17-
Potassium, Day 280.10-
Potassium, Day 42-0.05-
Magnesium, Day 70.0206-
Magnesium, Day 140.0069-
Magnesium, Day 280.0411-
Magnesium, Day 42-0.0274-
Sodium, Day 71.3-
Sodium, Day 141.5-
Sodium, Day 281.0-
Sodium, Day 42-1.0-
Urea/BUN, Day 70.179-
Urea/BUN, Day 140.178-
Urea/BUN, Day 280.714-
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 140.017-
Calcium, Day 280.035-
Calcium, Day 42-0.056-
Chloride, Day 70.4-
Chloride, Day 140.6-
Chloride, Day 280.3-
Chloride, Day 420.3-
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 420.1-
Potassium, Day 70.06-
Potassium, Day 140.07-
Potassium, Day 28-0.07-
Potassium, Day 420.08-
Magnesium, Day 7-0.0206-
Magnesium, Day 140.0206-
Magnesium, Day 280.0240-
Magnesium, Day 42-0.0171-
Sodium, Day 70.8-
Sodium, Day 141.5-
Sodium, Day 280.6-
Sodium, Day 42-1.0-
Urea/BUN, Day 7-0.208-
Urea/BUN, Day 14-0.268-
Urea/BUN, Day 280.863-
Urea/BUN, Day 42-0.387-
Cholesterol, Day 42-0.155-
Phosphorus inorganic, Day 70.01-
Phosphorus inorganic, Day 140.03-
Phosphorus inorganic, Day 280.12-
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

GroupMean · Micromoles (umol)/L95% CI
Part A-PlaceboDirect bilirubin, Day 70.000-
Direct bilirubin, Day 140.428-
Direct bilirubin, Day 28-0.428-
Direct bilirubin, Day 42-0.855-
Total bilirubin, Day 70.000-
Total bilirubin, Day 140.428-
Total bilirubin, Day 281.283-
Total bilirubin, Day 420.855-
Creatinine, Day 72.2-
Creatinine, Day 14-4.4-
Creatinine, Day 280.0-
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 420.513-
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 284.2-
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

GroupMean · umol/L95% CI
Part B-Placebo+LiraglutideDirect bilirubin, Day 70.542-
Direct bilirubin, Day 140.314-
Direct bilirubin, Day 280.513-
Direct bilirubin, Day 420.599-
Total bilirubin, Day 70.570-
Total bilirubin, Day 14-0.570-
Total bilirubin, Day 28-0.000-
Total bilirubin, Day 42-1.425-
Creatinine, Day 74.6-
Creatinine, Day 14-0.1-
Creatinine, Day 281.9-
Creatinine, Day 42-1.0-
Uric acid, Day 715.9-
Uric acid, Day 14-11.9-
Uric acid, Day 282.0-
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 280.132-
Total bilirubin, Day 420.263-
Creatinine, Day 73.0-
Creatinine, Day 144.2-
Creatinine, Day 282.0-
Creatinine, Day 42-2.4-
Uric acid, Day 725.1-
Uric acid, Day 1415.3-
Uric acid, Day 2816.9-
Uric acid, Day 427.8-
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 76.9-
Creatinine, Day 145.7-
Creatinine, Day 284.9-
Creatinine, Day 420.6-
Uric acid, Day 73.0-
Uric acid, Day 14-21.8-
Uric acid, Day 28-13.9-
Uric acid, Day 429.9-
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 70.000-
Total bilirubin, Day 140.285-
Total bilirubin, Day 280.998-
Total bilirubin, Day 42-0.428-
Creatinine, Day 73.4-
Creatinine, Day 144.6-
Creatinine, Day 288.2-
Creatinine, Day 42-0.8-
Uric acid, Day 79.9-
Uric acid, Day 1425.3-
Uric acid, Day 2834.7-
Uric acid, Day 420.5-
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

GroupMean · g/L95% CI
Part A-PlaceboAlbumin, Day 70.0-
Albumin, Day 142.0-
Albumin, Day 282.5-
Albumin, Day 422.5-
Total protein, Day 7-0.8-
Total protein, Day 14-0.3-
Total protein, Day 281.0-
Total protein, Day 420.8-
Part A-GSK2890457Albumin, Day 7-0.3-
Albumin, Day 140.4-
Albumin, Day 280.4-
Albumin, Day 420.0-
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

GroupMean · g/L95% CI
Part B-Placebo+LiraglutideAlbumin, Day 72.0-
Albumin, Day 142.7-
Albumin, Day 281.8-
Albumin, Day 420.0-
Total protein, Day 73.0-
Total protein, Day 144.0-
Total protein, Day 283.2-
Total protein, Day 420.5-
Part B-GSK2890457+LiraglutideAlbumin, Day 73.1-
Albumin, Day 142.6-
Albumin, Day 282.8-
Albumin, Day 420.4-
Total protein, Day 72.9-
Total protein, Day 142.7-
Total protein, Day 283.2-
Total protein, Day 42-0.6-
Part C-Placebo+MetforminAlbumin, Day 71.3-
Albumin, Day 140.8-
Albumin, Day 282.3-
Albumin, Day 42-0.8-
Total protein, Day 71.0-
Total protein, Day 141.7-
Total protein, Day 282.8-
Total protein, Day 42-0.7-
Part C-GSK2890457+MetforminAlbumin, Day 70.5-
Albumin, Day 141.6-
Albumin, Day 281.9-
Albumin, Day 42-1.3-
Total protein, Day 71.1-
Total protein, Day 142.2-
Total protein, Day 283.1-
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

GroupMean · Units (U)/L95% CI
Part B-Placebo+LiraglutideAmylase, Day 426.0-
Lipase, Day 427.5-
Part B-GSK2890457+LiraglutideAmylase, Day 429.2-
Lipase, Day 4218.8-
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

GroupMean · Ratio95% CI
Part B-Placebo+Liraglutide-0.018-
Part B-GSK2890457+Liraglutide-0.009-
Part C-Placebo+Metformin0.002-
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

GroupMean · Nanomoles (nmol)/L95% CI
Part B-Placebo+LiraglutideTotal thyroxine0.8578-
Total T3-0.3-
Part B-GSK2890457+LiraglutideTotal thyroxine1.0891-
Total T30.1-
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

GroupMean · Milliunits (mu/L)95% CI
Part B-GSK2890457+LiraglutideDay 7-5.790-
Day 42-0.067-
Part B-Placebo+LiraglutideDay 420.137-
Part C-Placebo+MetforminDay 42-0.187-
Part C-GSK2890457+MetforminDay 420.149-
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

GroupMean · Giga cells (GI)/L95% CI
Part A-PlaceboBasophils, Day 70.00-
Basophils, Day 14-0.03-
Basophils, Day 280.00-
Basophils, Day 420.00-
Eosinophils, Day 7-0.03-
Eosinophils, Day 14-0.03-
Eosinophils, Day 280.10-
Eosinophils, Day 420.03-
Lymphocytes, Day 7-0.22-
Lymphocytes, Day 14-0.22-
Lymphocytes, Day 28-0.23-
Lymphocytes, Day 420.15-
Monocytes, Day 7-0.08-
Monocytes, Day 14-0.10-
Monocytes, Day 28-0.05-
Monocytes, Day 42-0.05-
Total Neutrophils, Day 70.15-
Total Neutrophils, Day 140.50-
Total Neutrophils, Day 28-0.32-
Total Neutrophils, Day 420.48-
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 140.18-
WBC count, Day 28-0.50-
WBC count, Day 420.65-
Part A-GSK2890457Basophils, Day 70.00-
Basophils, Day 140.01-
Basophils, Day 280.00-
Basophils, Day 420.00-
Eosinophils, Day 7-0.03-
Eosinophils, Day 140.00-
Eosinophils, Day 280.00-
Eosinophils, Day 420.00-
Lymphocytes, Day 7-0.01-
Lymphocytes, Day 14-0.06-
Lymphocytes, Day 28-0.32-
Lymphocytes, Day 420.05-
Monocytes, Day 7-0.05-
Monocytes, Day 14-0.05-
Monocytes, Day 280.01-
Monocytes, Day 42-0.06-
Total Neutrophils, Day 70.02-
Total Neutrophils, Day 14-0.13-
Total Neutrophils, Day 280.14-
Total Neutrophils, Day 42-0.01-
Platelet count, Day 7-1.9-
Platelet count, Day 143.8-
Platelet count, Day 289.7-
Platelet count, Day 423.1-
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

GroupMean · GI/L95% CI
Part B-Placebo+LiraglutideBasophils, Day 70.0270-
Basophils, Day 140.0037-
Basophils, Day 28-0.0002-
Basophils, Day 420.0098-
Eosinophils, Day 70.02-
Eosinophils, Day 140.01-
Eosinophils, Day 280.01-
Eosinophils, Day 420.01-
Lymphocytes, Day 70.31-
Lymphocytes, Day 140.18-
Lymphocytes, Day 280.08-
Lymphocytes, Day 420.02-
Monocytes, Day 70.04-
Monocytes, Day 14-0.05-
Monocytes, Day 280.03-
Monocytes, Day 420.00-
Total Neutrophils, Day 70.27-
Total Neutrophils, Day 140.38-
Total Neutrophils, Day 28-0.01-
Total Neutrophils, Day 42-0.24-
Platelet count, Day 718.3-
Platelet count, Day 1412.8-
Platelet count, Day 284.5-
Platelet count, Day 42-2.0-
WBC count, Day 70.65-
WBC count, Day 140.52-
WBC count, Day 280.08-
WBC count, Day 42-0.20-
Part B-GSK2890457+LiraglutideBasophils, Day 70.0047-
Basophils, Day 140.0041-
Basophils, Day 280.0050-
Basophils, Day 420.0019-
Eosinophils, Day 70.04-
Eosinophils, Day 140.03-
Eosinophils, Day 280.02-
Eosinophils, Day 420.06-
Lymphocytes, Day 70.11-
Lymphocytes, Day 140.04-
Lymphocytes, Day 280.05-
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 78.9-
Platelet count, Day 147.0-
Platelet count, Day 2810.8-
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 70.0047-
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 280.01-
Eosinophils, Day 42-0.02-
Lymphocytes, Day 70.09-
Lymphocytes, Day 140.08-
Lymphocytes, Day 280.05-
Lymphocytes, Day 42-0.11-
Monocytes, Day 70.01-
Monocytes, Day 140.06-
Monocytes, Day 280.06-
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 75.0-
Platelet count, Day 141.2-
Platelet count, Day 280.5-
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 70.14-
Lymphocytes, Day 140.18-
Lymphocytes, Day 280.25-
Lymphocytes, Day 42-0.07-
Monocytes, Day 70.00-
Monocytes, Day 140.06-
Monocytes, Day 280.03-
Monocytes, Day 42-0.03-
Total Neutrophils, Day 70.38-
Total Neutrophils, Day 140.64-
Total Neutrophils, Day 280.36-
Total Neutrophils, Day 42-0.10-
Platelet count, Day 75.8-
Platelet count, Day 1412.9-
Platelet count, Day 2810.4-
Platelet count, Day 42-15.3-
WBC count, Day 70.48-
WBC count, Day 140.88-
WBC count, Day 280.63-
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

GroupMean · g/L95% CI
Part A-PlaceboHemoglobin, Day 70.8-
Hemoglobin, Day 144.0-
Hemoglobin, Day 2811.3-
Hemoglobin, Day 429.8-
MCHC, Day 71.8-
MCHC, Day 14-0.5-
MCHC, Day 288.5-
MCHC, Day 4217.5-
Part A-GSK2890457Hemoglobin, Day 7-2.0-
Hemoglobin, Day 14-0.9-
Hemoglobin, Day 280.5-
Hemoglobin, Day 420.9-
MCHC, Day 75.4-
MCHC, Day 140.0-
MCHC, Day 286.3-
MCHC, Day 429.0-
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

GroupMean · g/L95% CI
Part B-Placebo+LiraglutideHemoglobin, Day 70.2-
Hemoglobin, Day 140.2-
Hemoglobin, Day 280.3-
Hemoglobin, Day 420.0-
MCHC, Day 7-2.0-
MCHC, Day 142.0-
MCHC, Day 281.7-
MCHC, Day 422.0-
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 420.2-
Part C-Placebo+MetforminHemoglobin, Day 7-4.3-
Hemoglobin, Day 141.7-
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 420.8-
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

GroupMean · Trillion cells (TI)/L95% CI
Part A-PlaceboRBC count, Day 7-0.008-
RBC count, Day 140.090-
RBC count, Day 280.258-
RBC count, Day 420.107-
Reticulocytes, Day 70.0115-
Reticulocytes, Day 140.0077-
Reticulocytes, Day 280.0073-
Reticulocytes, Day 420.0022-
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 70.0014-
Reticulocytes, Day 14-0.0017-
Reticulocytes, Day 280.0071-
Reticulocytes, Day 420.0044-
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

GroupMean · TI/L95% CI
Part B-Placebo+LiraglutideRBC count, Day 70.018-
RBC count, Day 14-0.030-
RBC count, Day 280.002-
RBC count, Day 420.032-
Reticulocytes, Day 70.0020-
Reticulocytes, Day 14-0.0019-
Reticulocytes, Day 280.0029-
Reticulocytes, Day 420.0062-
Part B-GSK2890457+LiraglutideRBC count, Day 70.004-
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 140.0095-
Reticulocytes, Day 280.0035-
Reticulocytes, Day 420.0096-
Part C-Placebo+MetforminRBC count, Day 7-0.107-
RBC count, Day 140.093-
RBC count, Day 280.020-
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 140.0147-
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

GroupMean · Ratio95% CI
Part A-PlaceboDay 70.0000-
Day 140.0128-
Day 280.0228-
Day 420.0060-
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

GroupMean · Ratio95% CI
Part B-Placebo+LiraglutideDay 70.0032-
Day 14-0.0028-
Day 28-0.0003-
Day 42-0.0022-
Part B-GSK2890457+LiraglutideDay 70.0019-
Day 140.0011-
Day 28-0.0003-
Day 42-0.0025-
Part C-Placebo+MetforminDay 7-0.0082-
Day 140.0057-
Day 28-0.0010-
Day 42-0.0087-
Part C-GSK2890457+MetforminDay 7-0.0072-
Day 14-0.0036-
Day 280.0003-
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

GroupMean · Picograms95% CI
Part A-PlaceboDay 70.25-
Day 140.27-
Day 280.70-
Day 421.40-
Part A-GSK2890457Day 70.31-
Day 140.32-
Day 280.37-
Day 420.89-
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

GroupMean · Picograms95% CI
Part B-Placebo+LiraglutideDay 7-0.02-
Day 140.18-
Day 280.17-
Day 42-0.12-
Part B-GSK2890457+LiraglutideDay 7-0.21-
Day 14-0.10-
Day 280.01-
Day 420.08-
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 140.03-
Day 28-0.08-
Day 420.02-
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

GroupMean · Femtoliters95% CI
Part A-PlaceboDay 70.15-
Day 140.85-
Day 28-0.30-
Day 42-0.90-
Part A-GSK2890457Day 7-0.55-
Day 140.95-
Day 28-0.62-
Day 420.35-
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

GroupMean · Femtoliters95% CI
Part B-Placebo+LiraglutideDay 70.35-
Day 140.02-
Day 280.05-
Day 42-0.90-
Part B-GSK2890457+LiraglutideDay 70.39-
Day 140.54-
Day 280.55-
Day 420.07-
Part C-Placebo+MetforminDay 70.40-
Day 14-0.47-
Day 28-0.18-
Day 42-0.78-
Part C-GSK2890457+MetforminDay 70.25-
Day 140.76-
Day 280.17-
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

GroupParticipants95% CI
Part A-PlaceboProtein, Trace, Day 11-
Protein, Trace, Day 70-
Protein, 1+, Day 70-
Protein, Trace, Day 140-
Protein, Trace, Day 281-
Protein, Trace, Day 422-
Bacteria, Rare, Day 11-
Bacteria, Rare, Day 420-
Bacteria, Moderate, Day 421-
Occult blood, Trace, Day 11-
Occult blood, Trace, Day 141-
Occult blood, Trace, Day 280-
Ketones, 1+, Day 11-
Ketones, 1+, Day 70-
Ketones, Trace, Day 141-
Ketones, Trace, Day 281-
Ketones, Trace, Day 421-
RBC's, 1, Day 11-
RBC's, 3, Day 11-
RBC's, <1, Day 10-
RBC's, 1, Day 70-
RBC's, <1, Day 70-
RBC's, 2, Day 141-
RBC's, <1, Day 140-
RBC's, 1, Day 280-
RBC's, <1, Day 282-
RBC's, 1, Day 420-
RBC's, 2, Day 422-
RBC's, <1, Day 420-
WBC's, 1, Day 12-
WBC's, <1, Day 10-
WBC's, 1, Day 70-
WBC's, <1, Day 70-
WBC's, 2, Day 141-
WBC's, <1, Day 141-
WBC's, 1, Day 282-
WBC's, <1, Day 280-
WBC's, 1, Day 420-
WBC's, 2, Day 421-
WBC's, 4, Day 421-
Part A-GSK2890457Protein, Trace, Day 13-
Protein, Trace, Day 72-
Protein, 1+, Day 71-
Protein, Trace, Day 141-
Protein, Trace, Day 284-
Protein, Trace, Day 422-
Bacteria, Rare, Day 10-
Bacteria, Rare, Day 421-
Bacteria, Moderate, Day 420-
Occult blood, Trace, Day 10-
Occult blood, Trace, Day 141-
Occult blood, Trace, Day 281-
Ketones, 1+, Day 10-
Ketones, 1+, Day 71-
Ketones, Trace, Day 140-
Ketones, Trace, Day 280-
Ketones, Trace, Day 420-
RBC's, 1, Day 11-
RBC's, 3, Day 10-
RBC's, <1, Day 11-
RBC's, 1, Day 71-
RBC's, <1, Day 71-
RBC's, 2, Day 140-
RBC's, <1, Day 142-
RBC's, 1, Day 282-
RBC's, <1, Day 282-
RBC's, 1, Day 421-
RBC's, 2, Day 420-
RBC's, <1, Day 421-
WBC's, 1, Day 12-
WBC's, <1, Day 11-
WBC's, 1, Day 72-
WBC's, <1, Day 71-
WBC's, 2, Day 141-
WBC's, <1, Day 141-
WBC's, 1, Day 280-
WBC's, <1, Day 281-
WBC's, 1, Day 421-
WBC's, 2, Day 420-
WBC's, 4, Day 421-
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

GroupParticipants95% CI
Part B-Placebo+LiraglutideBacteria, Few, Day -11-
Occult Blood, 1+, Day 140-
Occult Blood, Trace, Day 280-
Occult Blood, Trace, Day 420-
Epithelial Cells, 10-20, Day -11-
Epithelial Cells, 0-5, Day 71-
Epithelial Cells, 6-10, Day 71-
Epithelial Cells, 0-5, Day 141-
Epithelial Cells, 0-5, Day 421-
Glucose, 1+, Day -10-
Glucose, 3+, Day -10-
Glucose, Trace, Day -12-
Glucose, 1+, Day 70-
Glucose, 3+, Day 71-
Glucose, Trace, Day 70-
Glucose, 1+, Day 140-
Glucose, 2+, Day 140-
Glucose, 3+, Day 141-
Glucose, Trace, Day 140-
Glucose, 1+, Day 280-
Glucose, 2+, Day 281-
Glucose, 3+, Day 280-
Glucose, Trace, Day 280-
Glucose, 1+, Day 422-
Glucose, 2+, Day 420-
Glucose, 3+, Day 420-
Glucose, Trace, Day 421-
Hyaline Casts, 0-5, Day 141-
Ketones, 1+, Day 70-
Ketones, Trace, Day 142-
Ketones, Trace, Day 280-
RBC's, 0-3, Day-11-
RBC's, 0-3, Day 71-
RBC's, 0-3, Day 140-
RBC's, 0-3, Day 280-
RBC's, 0-3, Day 420-
WBC's, 20-40, Day -11-
WBC's, 0-5, Day 71-
WBC's, 6-10, Day 71-
WBC's, 0-5, Day 141-
WBC's, 0-5, Day 280-
WBC's, 0-5, Day 421-
Part B-GSK2890457+LiraglutideBacteria, Few, Day -10-
Occult Blood, 1+, Day 141-
Occult Blood, Trace, Day 281-
Occult Blood, Trace, Day 421-
Epithelial Cells, 10-20, Day -10-
Epithelial Cells, 0-5, Day 71-
Epithelial Cells, 6-10, Day 70-
Epithelial Cells, 0-5, Day 142-
Epithelial Cells, 0-5, Day 421-
Glucose, 1+, Day -14-
Glucose, 3+, Day -12-
Glucose, Trace, Day -11-
Glucose, 1+, Day 71-
Glucose, 3+, Day 72-
Glucose, Trace, Day 73-
Glucose, 1+, Day 141-
Glucose, 2+, Day 141-
Glucose, 3+, Day 141-
Glucose, Trace, Day 143-
Glucose, 1+, Day 282-
Glucose, 2+, Day 281-
Glucose, 3+, Day 282-
Glucose, Trace, Day 281-
Glucose, 1+, Day 420-
Glucose, 2+, Day 422-
Glucose, 3+, Day 423-
Glucose, Trace, Day 423-
Hyaline Casts, 0-5, Day 140-
Ketones, 1+, Day 71-
Ketones, Trace, Day 141-
Ketones, Trace, Day 281-
RBC's, 0-3, Day-10-
RBC's, 0-3, Day 70-
RBC's, 0-3, Day 141-
RBC's, 0-3, Day 281-
RBC's, 0-3, Day 421-
WBC's, 20-40, Day -10-
WBC's, 0-5, Day 71-
WBC's, 6-10, Day 70-
WBC's, 0-5, Day 141-
WBC's, 0-5, Day 281-
WBC's, 0-5, Day 421-
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

GroupParticipants95% CI
Part C-Placebo+MetforminProtein, 1+, Day 70-
Protein, Trace, Day 70-
Protein, Trace, Day 141-
Protein, 1+, Day 280-
Bacteria, Few, Day -10-
Bacteria, Many, Day -11-
Bacteria, Few, Day 70-
Bacteria, Many, Day 71-
Bacteria, Many, Day 140-
Bacteria, Moderate, Day 141-
Bacteria, Few, Day 281-
Bacteria, Many, Day 281-
Bacteria, Many, Day 421-
Bacteria, Moderate, Day 420-
Occult Blood, Trace, Day 420-
Epithelial Cells, 0-10, Day -10-
Epithelial Cells, 0-10, Day 70-
Epithelial Cells, 0-5, Day 70-
Epithelial Cells, 6-10, Day 70-
Epithelial Cells, 0-5, Day 140-
Epithelial Cells, >10, Day 140-
Epithelial Cells, 0-10, Day 281-
Epithelial Cells, 0-10, Day 420-
Glucose, 1+, Day -10-
Glucose, 2+, Day -10-
Glucose, 3+, Day -10-
Glucose, 1+, Day 71-
Glucose, 2+, Day 70-
Glucose, 3+, Day 71-
Glucose, Trace, Day 71-
Glucose, 1+, Day 141-
Glucose, 3+, Day 140-
Glucose, Trace, Day 140-
Glucose, 2+, Day 281-
Glucose, 3+, Day 281-
Glucose, Trace, Day 280-
Glucose, 1+, Day 423-
Glucose, 2+, Day 420-
Glucose, 3+, Day 420-
Glucose, Trace, Day 420-
Hyaline Casts, 0-1, Day 70-
Ketones, 1+, Day 70-
Ketones, Trace, Day 70-
Ketones, Trace, Day 141-
Ketones, Trace, Day 281-
RBC's, 0-3, Day -10-
RBC's, 0-3, Day 70-
RBC's, 0-3, Day 140-
RBC's, 0-3, Day 281-
RBC's, 0-3, Day 420-
Uric acid crystals, Moderate, Day 70-
Uric acid crystals, Few, Day 140-
WBC's, 0-5, Day -11-
WBC's, 0-5, Day 71-
WBC's, 6-10, Day 70-
WBC's, 0-5, Day 141-
WBC's, 0-5, Day 281-
WBC's, 40-60, Day 281-
WBC's, 6-10, Day 421-
Part C-GSK2890457+MetforminProtein, 1+, Day 71-
Protein, Trace, Day 72-
Protein, Trace, Day 141-
Protein, 1+, Day 281-
Bacteria, Few, Day -11-
Bacteria, Many, Day -10-
Bacteria, Few, Day 74-
Bacteria, Many, Day 70-
Bacteria, Many, Day 141-
Bacteria, Moderate, Day 140-
Bacteria, Few, Day 281-
Bacteria, Many, Day 280-
Bacteria, Many, Day 420-
Bacteria, Moderate, Day 421-
Occult Blood, Trace, Day 421-
Epithelial Cells, 0-10, Day -11-
Epithelial Cells, 0-10, Day 71-
Epithelial Cells, 0-5, Day 71-
Epithelial Cells, 6-10, Day 71-
Epithelial Cells, 0-5, Day 141-
Epithelial Cells, >10, Day 141-
Epithelial Cells, 0-10, Day 281-
Epithelial Cells, 0-10, Day 421-
Glucose, 1+, Day -11-
Glucose, 2+, Day -11-
Glucose, 3+, Day -16-
Glucose, 1+, Day 70-
Glucose, 2+, Day 72-
Glucose, 3+, Day 71-
Glucose, Trace, Day 72-
Glucose, 1+, Day 142-
Glucose, 3+, Day 142-
Glucose, Trace, Day 144-
Glucose, 2+, Day 282-
Glucose, 3+, Day 281-
Glucose, Trace, Day 282-
Glucose, 1+, Day 422-
Glucose, 2+, Day 421-
Glucose, 3+, Day 424-
Glucose, Trace, Day 421-
Hyaline Casts, 0-1, Day 71-
Ketones, 1+, Day 71-
Ketones, Trace, Day 72-
Ketones, Trace, Day 141-
Ketones, Trace, Day 281-
RBC's, 0-3, Day -11-
RBC's, 0-3, Day 72-
RBC's, 0-3, Day 142-
RBC's, 0-3, Day 281-
RBC's, 0-3, Day 421-
Uric acid crystals, Moderate, Day 71-
Uric acid crystals, Few, Day 141-
WBC's, 0-5, Day -11-
WBC's, 0-5, Day 73-
WBC's, 6-10, Day 71-
WBC's, 0-5, Day 142-
WBC's, 0-5, Day 281-
WBC's, 40-60, Day 280-
WBC's, 6-10, Day 421-
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

GroupMean · pH95% CI
Part B-Placebo+LiraglutideDay -15.92-
Day 75.83-
Day 145.67-
Day 285.75-
Day 426.00-
Part B-GSK2890457+LiraglutideDay -16.25-
Day 75.89-
Day 146.07-
Day 285.96-
Day 426.08-
Part C-Placebo+MetforminDay -15.67-
Day 75.83-
Day 145.67-
Day 285.67-
Day 425.58-
Part C-GSK2890457+MetforminDay -15.83-
Day 75.42-
Day 145.63-
Day 285.63-
Day 425.58-
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

GroupMean · Milliseconds95% CI
Part A-PlaceboPR Interval, Day 426.3-
PR Interval, Follow-up9.0-
QRS Duration, Day 422.2-
QRS Duration, Follow-up3.9-
QT Interval, Day 4210.8-
QT Interval, Follow-up0.3-
QTcB, Day 428.2-
QTcB, Follow-up6.9-
QTcF, Day 429.1-
QTcF, Follow-up4.8-
Part A-GSK2890457PR Interval, Day 421.1-
PR Interval, Follow-up1.5-
QRS Duration, Day 42-2.1-
QRS Duration, Follow-up-0.7-
QT Interval, Day 4216.4-
QT Interval, Follow-up-10.2-
QTcB, Day 42-3.3-
QTcB, Follow-up6.3-
QTcF, Day 423.2-
QTcF, Follow-up0.7-
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

GroupMean · Milliseconds95% CI
Part B-Placebo+LiraglutidePR Interval, Day 425.56-
PR Interval, Follow-up-1.11-
QRS Duration, Day 420.78-
QRS Duration, Follow-up0.11-
QT Interval, Day 428.11-
QT Interval, Follow-up1.44-
QTcB, Day 42-2.87-
QTcB, Follow-up-5.89-
QTcF, Day 421.17-
QTcF, Follow-up-3.17-
RR Interval, Day 420.04-
RR Interval, Follow-up0.03-
Part B-GSK2890457+LiraglutidePR Interval, Day 423.08-
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-up0.02-
Part C-Placebo+MetforminPR Interval, Day 42-6.44-
PR Interval, Follow-up-3.11-
QRS Duration, Day 420.11-
QRS Duration, Follow-up0.78-
QT Interval, Day 422.78-
QT Interval, Follow-up0.78-
QTcB, Day 420.43-
QTcB, Follow-up-3.20-
QTcF, Day 421.22-
QTcF, Follow-up-1.78-
RR Interval, Day 420.01-
RR Interval, Follow-up0.02-
Part C-GSK2890457+MetforminPR Interval, Day 42-4.44-
PR Interval, Follow-up-6.28-
QRS Duration, Day 42-1.06-
QRS Duration, Follow-up0.11-
QT Interval, Day 420.78-
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 420.02-
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

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

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

GroupGeometric mean · Hour*nanograms/mL95% CI
Part B-Placebo+LiraglutideDay -12210.15-
Day 422505.23-
Part B-GSK2890457+LiraglutideDay -11268.65-
Day 421265.92-
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

GroupGeometric mean · Nanograms/mL95% CI
Part B-Placebo+LiraglutideDay -1120.00-
Day 42128.57-
Part B-GSK2890457+LiraglutideDay -172.24-
Day 4270.86-
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

GroupMedian · Hours95% CI
Part B-Placebo+LiraglutideDay -19.742.0 - 11.5
Day 429.922.1 - 11.5
Part B-GSK2890457+LiraglutideDay -18.000.0 - 11.5
Day 429.980.8 - 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

GroupGeometric mean · Hour*nanograms/mL95% CI
Part A-PlaceboDay 14346.8-
Day 425081.9-
Part A-GSK2890457Day 13402.6-
Day 422231.7-
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

GroupGeometric mean · Nanograms/mL95% CI
Part A-PlaceboDay 1681.8-
Day 42860.1-
Part A-GSK2890457Day 1576.2-
Day 42374.1-
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

GroupMedian · Hours95% CI
Part A-PlaceboDay 13.0102.00 - 4.03
Day 424.0002.00 - 4.03
Part A-GSK2890457Day 12.0001.00 - 4.00
Day 422.0002.00 - 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 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 6, 2026 snapshot.