CompletedPhase 3Results posted

Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus

Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

157

Recruiting sites

Actual enrollment

814

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≤40•HbA1c 7-9%

Primary endpoint

•HbA1c, change

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 IDNCT02229227

Org study ID200977

Secondary ID2014-001821-34

Timeline

Milestones

Study first posted2014-09-01estimated

Study start2014-11-21actual

Primary completion2017-07-24actual

Study completion2017-07-24actual

Results first posted2018-06-29actual

Last update posted2020-11-27actual

Assets

Investigational agents

Albiglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, 18 years of age or older (inclusive at the time of Screening) with T2DM

•HbA1c >= 7.0% and <= 9.0% at Screening.

•Currently treated with a basal-bolus insulin regimen (with or without metformin) for at least 3 months before Screening. The subject must be taking the following:

•Basal insulin (1 or 2 daily injections of neutral protamine Hagedorn insulin, insulin glargine, insulin detemir, or insulin degludec) AND

•Bolus insulin (at least 2 injections of regular insulin, insulin glulisine, insulin aspart, or insulin lispro) with a total daily dose of bolus insulin <= 70 units

•In addition, the total daily dose of insulin must be <= 140 units

•If taking metformin, a stable dose for at least 8 weeks before Screening Note: Subject should not have received any other antidiabetic medication within 30 days before screening (e.g., glucagon-like peptide-1 receptor (GLP-1R) agonist, dipeptidyl peptidase-IV inhibitor, SU, or thiazolidinedione). Subjects receiving commercially available premixed basal and prandial insulin are not eligible for this study.

•Fasting C-peptide >= 0.8 nanogram (ng) per milliliter (mL) [>= 0.26 nanomoles per litre (nmol/L)]

•Body mass index <= 40 kilogram per square meter( kg/m^2)

•Thyroid-stimulating hormone (TSH) level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., free T4)

•Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception (as defined in the protocol) for the duration of participation in the study including the 4-week post treatment Follow-up Period..

•Willing and able to comply with all study procedures including performance of frequent self-monitored blood glucose (SMBG) profiles according to the protocol

•Able and willing to provide written informed consent

Exclusion criteria

•Type 1 diabetes mellitus

•History of cancer that has not been in full remission for at least 3 years before Screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed)

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

•Current symptomatic biliary disease or history of acute or chronic pancreatitis

•Severe gastroparesis, i.e., requiring regular therapy within 6 months before Screening

•History of significant GI surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function [e.g., gastric bypass and banding, antrectomy, Roux-en-Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function]

•History of severe hypoglycemia unawareness

•Diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) or any other clinically significant abnormality (including a psychiatric disorder) that, in the opinion of the investigator, may pose additional risk in administering the investigational product

•Clinically significant CV and/or cerebrovascular disease within 3 months before Screening including, but not limited to, the following:

•Stroke or transient ischemic attack

•Acute coronary syndrome (myocardial infarction [MI] or unstable angina not responsive to nitroglycerin)

•Cardiac surgery or percutaneous coronary procedure

•Current or history of heart failure (New York Heart Association class III or IV)

•Alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN) or bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

•Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). (Chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria and is not on active antiviral treatment [e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of Screening])

•Hemoglobin <11 gram (g) per (dL) [<110 g/L] for male subjects and <10 g/dL (<100 g/L) for female subjects at Screening

•Estimated glomerular filtration rate (eGFR) <= 30 millilitre per minute per 1.73 square meters (mL/min/1.73 m^2) (calculated using the Modification of Diet in Renal Disease [MDRD] formula) at Screening Note: As the use of metformin in subjects with varying degrees of renal function may differ from country to country, use of metformin should be in accordance with the metformin product label within the participating country.

•Fasting triglyceride level >750 mg/dL at Screening

•Hemoglobinopathy that may affect proper interpretation of HbA1c

•Known allergy to albiglutide or any product components (including yeast and human albumin), any other GLP-1 analogue, insulin, or other study medication's excipients OR other contraindications (per the prescribing information) for the use of potential study medications (e.g., insulin glargine, insulin lispro)

•Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 6 months following randomization. However, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the medical monitor. Inhaled, intra-articular, epidural, and topical corticosteroids are allowed

•Female subject is pregnant (confirmed by laboratory testing) or lactating

•Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is longer, before Screening, a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of albiglutide in previous studies

Endpoints (40)

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

Glycemic / diabetes

Safety / tolerability / PK

Renal / kidney

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 26

Time frame:Baseline (Day -1) and Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · Kilograms	95% CI
Albiglutide + Insulin Glargine	-1.95	-
Insulin Lispro + Insulin Glargine	2.43	-

Mean difference (net)-4.3795% CI-4.93 - -3.82p<0.0001t-test, 2 sided

Secondary/protocol endpoint

Change From Baseline to Week 26 in Body Weight

Time frame:Baseline (Day -1) to Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · Kilograms	95% CI
Albiglutide + Insulin GlargineWeek 4, n=368,384	-0.55	-
Week 5, n=382,393	-0.95	-
Week 10, n=379,397	-1.71	-
Week 18, n=365,372	-1.96	-
Week 26, n=349,352	-1.95	-
Insulin Lispro + Insulin GlargineWeek 4, n=368,384	0.66	-
Week 5, n=382,393	0.85	-
Week 10, n=379,397	1.46	-
Week 18, n=365,372	2.06	-
Week 26, n=349,352	2.43	-

Mean difference (net)-1.2195% CI-1.43 - -1.00

Week 4

Mean difference (net)-1.8095% CI-2.05 - -1.55

Week 5

Mean difference (net)-3.1795% CI-3.51 - -2.82

Week 10

Mean difference (net)-4.0195% CI-4.48 - -3.54

Week 18

Mean difference (net)-4.3795% CI-4.93 - -3.82p<0.0001t-test, 2 sided

Week 26

Glycemic / diabetes

19 endpoints

Primary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

Time frame:Baseline (Day -1) and Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percentage of glycosylated hemoglobin	95% CI
Albiglutide + Insulin Glargine	-1.04	-
Insulin Lispro + Insulin Glargine	-1.10	-

Mean difference (net)0.0695% CI-0.05 - 0.17p<0.0001t-test, 2 sided

Secondary/protocol endpoint

Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26

Time frame:Up to Week 26

threshold achievement, improvement

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin Glargine	218	-

Secondary/protocol endpoint

Total Daily Insulin Dose at Week 26

Time frame:Week 26

descriptive

Posted result

Group	Least-squares mean · International Units	95% CI
Albiglutide + Insulin Glargine	70.36	-
Insulin Lispro + Insulin Glargine	131.19	-

Mean difference (final values)-60.8395% CI-66.57 - -55.10p<0.0001t-test, 2 sided

Secondary/protocol endpoint

Change From Baseline to Week 26 in HbA1c

Time frame:Baseline to Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percentage of glycosylated hemoglobin	95% CI
Albiglutide + Insulin GlargineWeek 4, n=358,375	-0.59	-
Week 5, n=374,392	-0.67	-
Week 10, n=376,390	-0.88	-
Week 18, n=360,365	-1.04	-
Week 26, n=345,350	-1.04	-
Insulin Lispro + Insulin GlargineWeek 4, n=358,375	-0.47	-
Week 5, n=374,392	-0.58	-
Week 10, n=376,390	-0.96	-
Week 18, n=360,365	-1.14	-
Week 26, n=345,350	-1.1	-

Mean difference (net)-0.1295% CI-0.18 - -0.07p<0.0001t-test, 1 sided

Week 4

Mean difference (net)-0.0995% CI-0.15 - -0.02p<0.0001t-test, 1 sided

Week 5

Mean difference (net)0.0895% CI-0.01 - 0.17p<0.0001t-test, 1 sided

Week 10

Mean difference (net)0.1195% CI0.01 - 0.21p<0.0001t-test, 1 sided

Week 18

Mean difference (net)0.0695% CI-0.05 - 0.17p<0.0001t-test, 1 sided

Week 26

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Time frame:Baseline and Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · Millimoles per Liter	95% CI
Albiglutide + Insulin Glargine	-2.01	-
Insulin Lispro + Insulin Glargine	-1.46	-

Mean difference (net)-0.5595% CI-0.86 - -0.25p0.0004t-test, 2 sided

Secondary/protocol endpoint

Change From Baseline to Week 26 in FPG

Time frame:Baseline to Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · Millimoles per Liter	95% CI
Albiglutide + Insulin GlargineWeek 4, n=356,371	-1.30	-
Week 5, n=366,388	-1.07	-
Week 18, n=348,353	-1.76	-
Week 26, n=345,349	-2.01	-
Insulin Lispro + Insulin GlargineWeek 4, n=356,371	-0.76	-
Week 5, n=366,388	-0.88	-
Week 18, n=348,353	-1.23	-
Week 26, n=345,349	-1.46	-

Mean difference (net)-0.5495% CI-0.84 - -0.24

Week 4

Mean difference (net)-0.1995% CI-0.51 - 0.13

Week 5

Mean difference (net)-0.5395% CI-0.85 - -0.22

Week 18

Mean difference (net)-0.5595% CI-0.86 - -0.25p0.0004t-test, 2 sided

Week 26

Secondary/protocol endpoint

Number of Participants Achieving HbA1c <7.0% at Week 26

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin Glargine	244	-
Insulin Lispro + Insulin Glargine	255	-

Odds ratio (or)0.9695% CI0.71 - 1.31p0.7026Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Number of Participants Achieving HbA1c <7.0% up to Week 26

Time frame:Up to Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineWeek 4	142	-
Week 5	157	-
Week 10	220	-
Week 18	251	-
Week 26	244	-
Insulin Lispro + Insulin GlargineWeek 4	139	-
Week 5	182	-
Week 10	261	-
Week 18	281	-
Week 26	255	-

Odds ratio (or)1.1795% CI0.84 - 1.64p0.2883Cochran-Mantel-Haenszel

Week 4

Odds ratio (or)0.8295% CI0.59 - 1.15p0.3034Cochran-Mantel-Haenszel

Week 5

Odds ratio (or)0.7195% CI0.52 - 0.98p0.0151Cochran-Mantel-Haenszel

Week 10

Odds ratio (or)0.7595% CI0.54 - 1.03p0.0518Cochran-Mantel-Haenszel

Week 18

Odds ratio (or)0.9695% CI0.71 - 1.31p0.7026Cochran-Mantel-Haenszel

Week 26

Secondary/protocol endpoint

Number of Participants Achieving a HbA1c <6.5% at Week 26

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin Glargine	147	-
Insulin Lispro + Insulin Glargine	169	-

Odds ratio (or)0.8595% CI0.63 - 1.17p0.2298Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Number of Participants Achieving a HbA1c <6.5% up to Week 26

Time frame:Up to Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineWeek 4	39	-
Week 5	63	-
Week 10	116	-
Week 18	150	-
Week 26	147	-
Insulin Lispro + Insulin GlargineWeek 4	33	-
Week 5	62	-
Week 10	140	-
Week 18	178	-
Week 26	169	-

Odds ratio (or)1.3295% CI0.78 - 2.23p0.2143Cochran-Mantel-Haenszel

Week 4

Odds ratio (or)1.2495% CI0.80 - 1.91p0.4703Cochran-Mantel-Haenszel

Week 5

Odds ratio (or)0.8195% CI0.58 - 1.14p0.2139Cochran-Mantel-Haenszel

Week 10

Odds ratio (or)0.8195% CI0.59 - 1.11p0.0790Cochran-Mantel-Haenszel

Week 18

Odds ratio (or)0.8595% CI0.63 - 1.17p0.2298Cochran-Mantel-Haenszel

Week 26

Secondary/protocol endpoint

Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26

Time frame:Week 26

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin Glargine	3	-
Insulin Lispro + Insulin Glargine	3	-

Odds ratio (or)1.0895% CI0.24 - 4.77p0.8292Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26

Time frame:Up to Week 26

event count, event

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin Glargine0 to <=4 Weeks	0	-
>4 to <=5 Weeks	0	-
>5 to <=10 Weeks	2	-
>10 to <=18 Weeks	0	-
>18 to <=26 Weeks	1	-
Insulin Lispro + Insulin Glargine0 to <=4 Weeks	0	-
>4 to <=5 Weeks	0	-
>5 to <=10 Weeks	0	-
>10 to <=18 Weeks	1	-
>18 to <=26 Weeks	2	-

Secondary/protocol endpoint

Total Daily Insulin Dose at Week 4, Week 10 and Week 18

Time frame:Weeks 4, 10, and 18

descriptive

Posted result

Group	Least-squares mean · International Units	95% CI
Albiglutide + Insulin GlargineWeek 4, n=388,403	50.53	-
Week 10, n=375,386	57.99	-
Week 18, n=359,361	68.23	-
Insulin Lispro + Insulin GlargineWeek 4, n=388,403	106.91	-
Week 10, n=375,386	121.69	-
Week 18, n=359,361	130.22	-

Mean difference (final values)-56.3895% CI-59.19 - -53.57

Week 4

Mean difference (final values)-63.7095% CI-67.78 - -59.62

Week 10

Mean difference (final values)-62.0095% CI-67.29 - -56.70

Week 18

Secondary/protocol endpoint/low confidence

Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits

Time frame:Weeks 4, 10, 18, and 26

descriptive

Posted result

Group	Least-squares mean · International Units	95% CI
Albiglutide + Insulin GlargineWeek 4, n=388,403	49.97	-
Week 10, n=375,386	56.14	-
Week 18, n=359,361	59.42	-
Week 26, n=342,341	59.83	-
Insulin Lispro + Insulin GlargineWeek 4, n=388,403	50.94	-
Week 10, n=375,386	55.79	-
Week 18, n=359,361	59.18	-
Week 26, n=342,341	59.43	-

Mean difference (final values)-0.9795% CI-2.25 - 0.30

Week 4

Mean difference (final values)0.3495% CI-1.64 - 2.33

Week 10

Mean difference (final values)0.2495% CI-2.21 - 2.69

Week 18

Mean difference (final values)0.3995% CI-2.25 - 3.04p0.7699t-test, 2 sided

Week 26

Secondary/protocol endpoint

Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits

Time frame:Weeks 4, 10, 18, and 26

change from baseline, improvement

Posted result

Group	Least-squares mean · International Units	95% CI
Albiglutide + Insulin GlargineWeek 4, n=388,403	0.62	-
Week 10, n=375,386	1.90	-
Week 18, n=359,361	8.89	-
Week 26, n=342,341	10.64	-
Insulin Lispro + Insulin GlargineWeek 4, n=388,403	56.67	-
Week 10, n=375,386	66.66	-
Week 18, n=359,361	71.81	-
Week 26, n=342,341	72.47	-

Mean difference (final values)-56.0595% CI-58.17 - -53.94

Week 4

Mean difference (final values)-64.7695% CI-67.68 - -61.85

Week 10

Mean difference (final values)-62.9295% CI-66.69 - -59.15

Week 18

Mean difference (final values)-61.8395% CI-65.85 - -57.81p<0.0001t-test, 2 sided

week 26

Secondary/protocol endpoint

Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26

Time frame:Baseline (Day -1) and Weeks 4, 10, 18 and 26

descriptive

Posted result

Group	Mean · Insulin Injections	95% CI
Albiglutide + Insulin GlargineBaseline, n=401,412	28.79	-
Week 4, n=388,403	8.11	-
Week 10, n=375,386	9.06	-
Week 18, n=359,361	12.62	-
Week 26, n=342,341	13.22	-
Insulin Lispro + Insulin GlargineBaseline, n=401,412	28.00	-
Week 4, n=388,403	28.00	-
Week 10, n=375,386	28.00	-
Week 18, n=359,361	28.00	-
Week 26, n=342,341	28.00	-

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · Percentage of participants	95% CI
Albiglutide + Insulin Glargine	49.8	-
Insulin Lispro + Insulin Glargine	21.4	-

Odds ratio (or)3.5095% CI2.52 - 4.86p<0.0001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · Percentage of participants	95% CI
Albiglutide + Insulin Glargine	21.1	-
Insulin Lispro + Insulin Glargine	9.5	-

Odds ratio (or)2.3695% CI1.54 - 3.60p<0.0001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · Percentage of participants	95% CI
Albiglutide + Insulin Glargine	15.9	-
Insulin Lispro + Insulin Glargine	3.9	-

Odds ratio (or)3.7895% CI2.21 - 6.48p<0.0001Cochran-Mantel-Haenszel

Renal / kidney

6 endpoints

Secondary/protocol endpoint

Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26

Time frame:Week 0 and Week 26

uACR, change

ratio, improvement

LOINC 9318-7

Posted result

Group	Mean · Grams per mole	95% CI
Albiglutide + Insulin GlargineWeek 0, n=369,376	14.40	-
Week 26, n=317,324	10.37	-
Insulin Lispro + Insulin GlargineWeek 0, n=369,376	11.57	-
Week 26, n=317,324	11.55	-

Secondary/protocol endpoint

Mean Albumin at Week 0 and Week 26

Time frame:Week 0 and Week 26

descriptive, improvement

Posted result

Group	Mean · Milligrams per Liter	95% CI
Albiglutide + Insulin GlargineWeek 0, n=394,405	127.7	-
Week 26, n=348,345	110.5	-
Insulin Lispro + Insulin GlargineWeek 0, n=394,405	108.2	-
Week 26, n=348,345	146.3	-

Secondary/protocol endpoint

Mean Creatinine at Week 0 and Week 26

Time frame:Week 0 and Week 26

descriptive

Posted result

Group	Mean · Micromoles per Liter	95% CI
Albiglutide + Insulin GlargineWeek 0, n=395,406	10646.3	-
Week 26, n=350,345	11364.6	-
Insulin Lispro + Insulin GlargineWeek 0, n=395,406	10663.8	-
Week 26, n=350,345	11394.2	-

Secondary/protocol endpoint

Mean Specific Gravity at Week 0 and Week 26

Time frame:Week 0 and Week 26

descriptive

Posted result

Group	Mean · Ratio	95% CI
Albiglutide + Insulin GlargineWeek 0, n=388,402	1.0182	-
Week 26, n=347,343	1.0180	-
Insulin Lispro + Insulin GlargineWeek 0, n=388,402	1.0180	-
Week 26, n=347,343	1.0186	-

Secondary/protocol endpoint

Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26

Time frame:Week 0 and Week 26

descriptive

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineNone Seen; Week 0, n=171,187	119	-
0 to 1; Week 0, n=171,187	34	-
1 to 3; Week 0, n=171,187	9	-
3 to 5; Week 0, n=171,187	3	-
5 to 10; Week 0, n=171,187	2	-
10 to 15; Week 0, n=171,187	0	-
15 to 25; Week 0, n=171,187	2	-
50 to 100; Week 0, n=171,187	0	-
>100; Week 0, n=171,187	2	-
None Seen; Week 26, n=166,144	98	-
0 to 1; Week 26, n=166,144	48	-
1 to 3; Week 26, n=166,144	8	-
3 to 5; Week 26, n=166,144	4	-
5 to 10; Week 26, n=166,144	4	-
25 to 50; Week 26, n=166,144	1	-
50 to 100; Week 26, n=166,144	2	-
>100; Week 26, n=166,144	1	-
Insulin Lispro + Insulin GlargineNone Seen; Week 0, n=171,187	101	-
0 to 1; Week 0, n=171,187	51	-
1 to 3; Week 0, n=171,187	14	-
3 to 5; Week 0, n=171,187	12	-
5 to 10; Week 0, n=171,187	4	-
10 to 15; Week 0, n=171,187	2	-
15 to 25; Week 0, n=171,187	1	-
50 to 100; Week 0, n=171,187	1	-
>100; Week 0, n=171,187	1	-
None Seen; Week 26, n=166,144	79	-
0 to 1; Week 26, n=166,144	36	-
1 to 3; Week 26, n=166,144	19	-
3 to 5; Week 26, n=166,144	3	-
5 to 10; Week 26, n=166,144	4	-
25 to 50; Week 26, n=166,144	2	-
50 to 100; Week 26, n=166,144	0	-
>100; Week 26, n=166,144	1	-

Secondary/protocol endpoint

Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26

Time frame:Week 0 and Week 26

categorical status, descriptive

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineNone Seen; Week 0, n=171,187	69	-
0 to 1; Week 0, n=171,187	27	-
1 to 3; Week 0, n=171,187	20	-
3 to 5; Week 0, n=171,187	16	-
5 to 10; Week 0, n=171,187	17	-
10 to 15; Week 0, n=171,187	7	-
15 to 25; Week 0, n=171,187	5	-
25 to 50; Week 0, n=171,187	5	-
50 to 100; Week 0, n=171,187	1	-
>100; Week 0, n=171,187	4	-
Innumerable; Week 0, n=171,187	0	-
None Seen; Week 26, n=166,144	65	-
0 to 1; Week 26, n=166,144	25	-
1 to 3; Week 26, n=166,144	22	-
3 to 5; Week 26, n=166,144	10	-
5 to 10; Week 26, n=166,144	22	-
10 to 15; Week 26, n=166,144	8	-
15 to 25; Week 26, n=166,144	3	-
20 to 50; Week 26, n=166,144	0	-
25 to 50; Week 26, n=166,144	5	-
50 to 100; Week 26, n=166,144	5	-
>100; Week 26, n=166,144	1	-
Innumerable; Week 26, n=166,144	0	-
Insulin Lispro + Insulin GlargineNone Seen; Week 0, n=171,187	67	-
0 to 1; Week 0, n=171,187	31	-
1 to 3; Week 0, n=171,187	18	-
3 to 5; Week 0, n=171,187	13	-
5 to 10; Week 0, n=171,187	19	-
10 to 15; Week 0, n=171,187	6	-
15 to 25; Week 0, n=171,187	11	-
25 to 50; Week 0, n=171,187	11	-
50 to 100; Week 0, n=171,187	7	-
>100; Week 0, n=171,187	3	-
Innumerable; Week 0, n=171,187	1	-
None Seen; Week 26, n=166,144	44	-
0 to 1; Week 26, n=166,144	29	-
1 to 3; Week 26, n=166,144	20	-
3 to 5; Week 26, n=166,144	15	-
5 to 10; Week 26, n=166,144	14	-
10 to 15; Week 26, n=166,144	5	-
15 to 25; Week 26, n=166,144	3	-
20 to 50; Week 26, n=166,144	1	-
25 to 50; Week 26, n=166,144	6	-
50 to 100; Week 26, n=166,144	5	-
>100; Week 26, n=166,144	1	-
Innumerable; Week 26, n=166,144	1	-

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26

Time frame:Baseline, Week 10 and Week 26

change from baseline, improvement

componentsTotal cholesterol, change, LDL-C, change, HDL-C, change, Triglycerides, change, Free fatty acids, change

Posted result

Group	Mean · Millimoles per Liters	95% CI
Albiglutide + Insulin GlargineTC: Week 10, n=376,393	-0.244	-
TC: Week 26, n=348,351	-0.059	-
HDL-c: Week 10, n=376,393	-0.041	-
HDL-c: Week 26, n=348,351	-0.013	-
TG: Week 10, n=376,393	-0.039	-
TG: Week 26, n=348,351	0.025	-
Insulin Lispro + Insulin GlargineTC: Week 10, n=376,393	0.041	-
TC: Week 26, n=348,351	0.073	-
HDL-c: Week 10, n=376,393	0.016	-
HDL-c: Week 26, n=348,351	0.005	-
TG: Week 10, n=376,393	-0.065	-
TG: Week 26, n=348,351	-0.028	-

Safety / tolerability / PK

12 endpoints

Secondary/protocol endpoint

Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26

Time frame:Up to Week 26

Documented hypoglycemia

threshold achievement, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Number · Percentage of participants	95% CI
Albiglutide + Insulin Glargine	57.2	-
Insulin Lispro + Insulin Glargine	75.0	-

Odds ratio (or)0.4395% CI0.31 - 0.60p<0.0001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication

Time frame:Up to Week 26

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any), Discontinuation due to AE

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineAE	261	-
SAE	23	-
AE leading to study medication discontinuation	12	-
Insulin Lispro + Insulin GlargineAE	254	-
SAE	31	-
AE leading to study medication discontinuation	6	-

Secondary/protocol endpoint

Number of Participants With Other AE of Special Interest

Time frame:Up to Week 26

event count, event

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineHypoglycemic Events	305	-
Cardiovascular Events	7	-
Gastrointestinal Events	102	-
Injection Site Reactions	8	-
Systemic Allergic Reactions	3	-
Pancreatitis	1	-
Pancreatic cancer	0	-
Malignant Neoplasm	2	-
Diabetic Retinopathy	4	-
Appendicitis	1	-
Liver Events	0	-
Pneumonia	1	-
Atrial Fibrillation/Flutter	4	-
Insulin Lispro + Insulin GlargineHypoglycemic Events	361	-
Cardiovascular Events	9	-
Gastrointestinal Events	53	-
Injection Site Reactions	1	-
Systemic Allergic Reactions	0	-
Pancreatitis	0	-
Pancreatic cancer	0	-
Malignant Neoplasm	2	-
Diabetic Retinopathy	17	-
Appendicitis	0	-
Liver Events	2	-
Pneumonia	3	-
Atrial Fibrillation/Flutter	1	-

Secondary/protocol endpoint

Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26

Time frame:Up to Week 26

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Number · Percentage of participants	95% CI
Albiglutide + Insulin GlargineAny event: Onset date falls under 0 to <= 12 weeks	55.3	-
Any event: Onset date falls > 12 to <= 26 Weeks	60.3	-
Severe: Onset date falls under 0 to <= 12 weeks	1.8	-
Severe: Onset date falls > 12 to <= 26 Weeks	0.8	-
DS: Onset date falls under 0 to <= 12 weeks	33.8	-
DS: Onset date falls > 12 to <= 26 Weeks	40.8	-
Asymptomatic: Onset date under 0 to <= 12 weeks	38.3	-
Asymptomatic: Onset date falls > 12 to <= 26 Weeks	44.3	-
Insulin Lispro + Insulin GlargineAny event: Onset date falls under 0 to <= 12 weeks	79.2	-
Any event: Onset date falls > 12 to <= 26 Weeks	79.4	-
Severe: Onset date falls under 0 to <= 12 weeks	3.6	-
Severe: Onset date falls > 12 to <= 26 Weeks	1.9	-
DS: Onset date falls under 0 to <= 12 weeks	63.0	-
DS: Onset date falls > 12 to <= 26 Weeks	62.0	-
Asymptomatic: Onset date under 0 to <= 12 weeks	56.9	-
Asymptomatic: Onset date falls > 12 to <= 26 Weeks	54.7	-

Secondary/protocol endpoint

Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria)

Time frame:Up to Week 26

Documented hypoglycemia

event count, event

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineSevere	9	-
Documented Symptomatic	203	-
Asymptomatic	230	-
Probably Symptomatic	29	-
Pseudohypoglycemia	45	-
Missing	9	-
Total	305	-
Insulin Lispro + Insulin GlargineSevere	22	-
Documented Symptomatic	299	-
Asymptomatic	293	-
Probably Symptomatic	52	-
Pseudohypoglycemia	83	-
Missing	13	-
Total	361	-

Secondary/protocol endpoint

Number of Participants With Daytime and Nocturnal Hypoglycemia

Time frame:Up to Week 26

Documented hypoglycemia

event count, event

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineAny (Total) Daytime Hypoglycemic Event	288	-
Any (Total) Nocturnal Hypoglycemic Event	155	-
Severe Daytime Hypoglycemic Event	6	-
Severe Nocturnal Hypoglycemic Event	4	-
Documented Symptomatic Daytime Hypoglycemic event	187	-
Documented Symptomatic Nocturnal Hypoglycemia	101	-
Asymptomatic Daytime Hypoglycemic event	217	-
Asymptomatic Nocturnal Hypoglycemic event	77	-
Probably Symptomatic Daytime Hypoglycemic event	22	-
Probably Symptomatic Nocturnal Hypoglycemic event	7	-
Pseudohypoglycemia Daytime Hypoglycemic event	36	-
Pseudohypoglycemia Nocturnal Hypoglycemic event	17	-
Missing Daytime Hypoglycemic Event	9	-
Mising Nocturnal Hypoglycemic Event	2	-
Insulin Lispro + Insulin GlargineAny (Total) Daytime Hypoglycemic Event	356	-
Any (Total) Nocturnal Hypoglycemic Event	225	-
Severe Daytime Hypoglycemic Event	14	-
Severe Nocturnal Hypoglycemic Event	6	-
Documented Symptomatic Daytime Hypoglycemic event	293	-
Documented Symptomatic Nocturnal Hypoglycemia	152	-
Asymptomatic Daytime Hypoglycemic event	281	-
Asymptomatic Nocturnal Hypoglycemic event	106	-
Probably Symptomatic Daytime Hypoglycemic event	44	-
Probably Symptomatic Nocturnal Hypoglycemic event	21	-
Pseudohypoglycemia Daytime Hypoglycemic event	70	-
Pseudohypoglycemia Nocturnal Hypoglycemic event	34	-
Missing Daytime Hypoglycemic Event	11	-
Mising Nocturnal Hypoglycemic Event	4	-

Secondary/protocol endpoint

Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms

Time frame:Up to Week 26

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin Glargine	141	-
Insulin Lispro + Insulin Glargine	239	-

Secondary/protocol endpoint

Number of Participants With Hematology Values of Clinical Concern

Time frame:Up to 30 weeks

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineHematocrit: >0.05 (fraction) below LLN	5	-
Hematocrit: >0.04 (fraction) above ULN	9	-
Hemoglobin: >20 g/L below LLN	9	-
Hemoglobin: >10 g/L above ULN	2	-
Leukocytes: >1 GI/L below LLN	1	-
Leukocytes: >5 GI/L above ULN	4	-
Neutrophils: <1 GI/L	2	-
Neutrophils, Segmented: <0.5 x LLN	2	-
Platelets: <80 GI/L	1	-
Platelets: >500 GI/L	3	-
Insulin Lispro + Insulin GlargineHematocrit: >0.05 (fraction) below LLN	6	-
Hematocrit: >0.04 (fraction) above ULN	12	-
Hemoglobin: >20 g/L below LLN	9	-
Hemoglobin: >10 g/L above ULN	3	-
Leukocytes: >1 GI/L below LLN	1	-
Leukocytes: >5 GI/L above ULN	1	-
Neutrophils: <1 GI/L	3	-
Neutrophils, Segmented: <0.5 x LLN	3	-
Platelets: <80 GI/L	1	-
Platelets: >500 GI/L	1	-

Secondary/protocol endpoint

Number of Participants With Clinical Chemistry Values of Clinical Concern

Time frame:Up to 30 weeks

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineFasting Serum Glucose: <3 mmol/L, n= 394,405	12	-
Fasting Serum Glucose: >22 mmol/L, n= 394,405	0	-
Fasting Plasma Glucose: <3 mmol/L, n= 388,406	9	-
Fasting Plasma Glucose: >22 mmol/L, n= 388,406	1	-
Albumin: >5 g/L below LLN, n=394,407	0	-
Albumin: >5 g/L above ULN, n=394,407	0	-
Calcium: <1.8 mmol/L, n=394,407	1	-
Calcium: >3.0 mmol/L, n=394,407	0	-
Carbon Dioxide: <16 mmol/L, n=394,407	5	-
Carbon Dioxide: >40 mmol/L, n=394,407	0	-
Magnesium: <0.411 mmol/L, n=394,407	1	-
Magnesium: >1.644 mmol/L, n=394,407	0	-
Phosphate: >0.323 mmol/L below LLN, n=394,407	0	-
Phosphate: >0.323 mmol/L above ULN, n=394,407	2	-
Potassium: >0.5 mmol/L below LLN, n=394,407	1	-
Potassium: >1.0 mmol/L above ULN, n=394,407	0	-
Protein: >15 g/L below LLN, n=394,407	0	-
Protein: >15 g/L above ULN, n=394,407	0	-
Sodium: >5 mmol/L below LLN, n=394,407	1	-
Sodium: >5 mmol/L above ULN, n=394,407	1	-
Triglycerides: >9.04 mmol/L, n=393,405	7	-
Urate: >654 μmol/L, n=394,407	0	-
Urea: >2 x ULN, n=394,407	2	-
Alanine Aminotransferase: >3 x ULN, n=396,410	0	-
Alkaline Phosphatase: >3 x ULN, n=396,410	1	-
Aspartate Aminotransferase: >3 x ULN, n=396,410	0	-
Bilirubin: >1.5 x ULN, n=396,410	1	-
Creatinine: >159 μmol/L, n=396,410	20	-
Direct Bilirubin: >1.35 x ULN, n=396,410	0	-
Gamma Glutamyl Transferase: >3 x ULN, n=396,410	14	-
Insulin Lispro + Insulin GlargineFasting Serum Glucose: <3 mmol/L, n= 394,405	16	-
Fasting Serum Glucose: >22 mmol/L, n= 394,405	1	-
Fasting Plasma Glucose: <3 mmol/L, n= 388,406	14	-
Fasting Plasma Glucose: >22 mmol/L, n= 388,406	0	-
Albumin: >5 g/L below LLN, n=394,407	0	-
Albumin: >5 g/L above ULN, n=394,407	0	-
Calcium: <1.8 mmol/L, n=394,407	1	-
Calcium: >3.0 mmol/L, n=394,407	0	-
Carbon Dioxide: <16 mmol/L, n=394,407	8	-
Carbon Dioxide: >40 mmol/L, n=394,407	0	-
Magnesium: <0.411 mmol/L, n=394,407	1	-
Magnesium: >1.644 mmol/L, n=394,407	0	-
Phosphate: >0.323 mmol/L below LLN, n=394,407	0	-
Phosphate: >0.323 mmol/L above ULN, n=394,407	4	-
Potassium: >0.5 mmol/L below LLN, n=394,407	0	-
Potassium: >1.0 mmol/L above ULN, n=394,407	1	-
Protein: >15 g/L below LLN, n=394,407	0	-
Protein: >15 g/L above ULN, n=394,407	0	-
Sodium: >5 mmol/L below LLN, n=394,407	0	-
Sodium: >5 mmol/L above ULN, n=394,407	0	-
Triglycerides: >9.04 mmol/L, n=393,405	1	-
Urate: >654 μmol/L, n=394,407	2	-
Urea: >2 x ULN, n=394,407	1	-
Alanine Aminotransferase: >3 x ULN, n=396,410	5	-
Alkaline Phosphatase: >3 x ULN, n=396,410	0	-
Aspartate Aminotransferase: >3 x ULN, n=396,410	2	-
Bilirubin: >1.5 x ULN, n=396,410	1	-
Creatinine: >159 μmol/L, n=396,410	16	-
Direct Bilirubin: >1.35 x ULN, n=396,410	1	-
Gamma Glutamyl Transferase: >3 x ULN, n=396,410	14	-

Secondary/protocol endpoint

Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26

Time frame:Week 0 and Week 26

descriptive

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlarginepH=5; Week 0, n=388,402	92	-
pH=5.5; Week 0, n=388,402	132	-
pH=6; Week 0, n=388,402	86	-
pH=6.5; Week 0, n=388,402	29	-
pH=7; Week 0, n=388,402	29	-
pH=7.5; Week 0, n=388,402	13	-
pH=8; Week 0, n=388,402	6	-
pH=8.5; Week 0, n=388,402	1	-
pH=5; Week 26, n=347,343	80	-
pH=5.5; Week 26, n=347,343	107	-
pH=6; Week 26, n=347,343	69	-
pH=6.5; Week 26, n=347,343	42	-
pH=7; Week 26, n=347,343	19	-
pH=7.5; Week 26, n=347,343	17	-
pH=8; Week 26, n=347,343	7	-
pH=8.5; Week 26, n=347,343	5	-
pH>9; Week 26, n=347,343	1	-
Insulin Lispro + Insulin GlarginepH=5; Week 0, n=388,402	107	-
pH=5.5; Week 0, n=388,402	132	-
pH=6; Week 0, n=388,402	77	-
pH=6.5; Week 0, n=388,402	43	-
pH=7; Week 0, n=388,402	24	-
pH=7.5; Week 0, n=388,402	11	-
pH=8; Week 0, n=388,402	7	-
pH=8.5; Week 0, n=388,402	1	-
pH=5; Week 26, n=347,343	100	-
pH=5.5; Week 26, n=347,343	104	-
pH=6; Week 26, n=347,343	70	-
pH=6.5; Week 26, n=347,343	23	-
pH=7; Week 26, n=347,343	23	-
pH=7.5; Week 26, n=347,343	18	-
pH=8; Week 26, n=347,343	5	-
pH=8.5; Week 26, n=347,343	0	-
pH>9; Week 26, n=347,343	0	-

Secondary/protocol endpoint

Number of Participants With Vital Signs of Clinical Concern

Time frame:Up to 30 weeks

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineSBP: < 100 mmHg	21	-
SBP: > 170 mmHg	27	-
DBP: < 50 mmHg	1	-
DBP: > 110 mmHg	1	-
Pulse Rate: < 50 bpm	4	-
Pulse Rate: > 120 bpm	3	-
Insulin Lispro + Insulin GlargineSBP: < 100 mmHg	20	-
SBP: > 170 mmHg	30	-
DBP: < 50 mmHg	4	-
DBP: > 110 mmHg	5	-
Pulse Rate: < 50 bpm	9	-
Pulse Rate: > 120 bpm	1	-

Secondary/protocol endpoint

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters

Time frame:Up to 30 weeks

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide + Insulin GlargineClinically Significant Change: Favorable	18	-
Clinically Significant Change: Unfavorable	4	-
Insulin Lispro + Insulin GlargineClinically Significant Change: Favorable	9	-
Clinically Significant Change: Unfavorable	5	-

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

Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial.
Diabetes care2020 Oct (month)PMID32694215doi:10.2337/dc19-2316via CT.gov background + pubmed nct search

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.