GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)

Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

467

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7.1-11%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

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

Identifiers

Registered as

NCT IDNCT00641056

Org study IDH8O-MC-GWBR (DURATION - 3)

Timeline

Milestones

Study first posted2008-03-21estimated

Results first posted2012-07-04estimated

Last update posted2015-06-15estimated

Study start2008-04 (month precision)

Primary completion2009-05actual (month precision)

Study completion2009-11actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Has type 2 diabetes and at least 18 years of age at screening.

•Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.

•Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.

•Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

•Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR

•Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.

Exclusion criteria

•Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.

•Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.

•Have a history of renal transplantation or are currently receiving renal dialysis.

•Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.

•Have had greater than three episodes of major hypoglycemia within 6 months prior to screening.

•Have any contraindication for the oral antidiabetic agent which they use.

•Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.

•Are known to have active proliferative retinopathy.

•Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.

•Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:

–Insulin

–Thiazolidinediones (e.g., Actos® [pioglitazone] or Avandia® [rosiglitazone])

–Alpha-glucosidase inhibitors (e.g., Glyset® [miglitol] or Precose® [acarbose])

–Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide]).

–Byetta® (exenatide BID formulation)

–Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin])

–Symlin® (pramlintide acetate).

•Have had an organ transplant.

•Have donated blood within 30 days of screening.

•Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.

•Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

•Are currently enrolled in any other clinical study.

Endpoints (10)

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

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight (BW) From Baseline to Week 26

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide Once Weekly	-2.63	—
Insulin Glargine	1.42	—

Least Squares Mean Difference-4.0595% CI-4.57 – -3.52p<.001Mixed Models Analysis

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change in HbA1c From Baseline to Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of total hemoglobin	95% CI
Exenatide Once Weekly	-1.47	—
Insulin Glargine	-1.31	—

Least Squares Mean Difference-0.1695% CI-0.29 – -0.03p0.017Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <=7.0% at Week 26

Time frame:Baseline, Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide Once Weekly	62.2	—
Insulin Glargine	54.1	—

p0.097Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <=6.5% at Week 26

Time frame:Baseline, Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of patients	95% CI
Exenatide Once Weekly	43.2	—
Insulin Glargine	28.4	—

p0.002Cochran-Mantel-Haenszel

Percentage of patients achieving HbA1c \<=6.5% at Week 26 were compared between treatments using a CMH test, in which background OAD and country served as the stratification factors.

Secondary/protocol endpoint

Change in Fasting Serum Glucose (FSG) From Baseline to Week 26

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Once Weekly	-2.13	—
Insulin Glargine	-2.76	—

Least Squares Mean Difference0.6395% CI0.25 – 1.00p0.001Mixed Models Analysis

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change in Total Cholesterol From Baseline to Week 26

Time frame:Baseline, Week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Once Weekly	-0.12	—
Insulin Glargine	-0.04	—

Least Squares Mean Difference-0.0795% CI-0.21 – 0.06p0.292Mixed Models Analysis

Secondary/protocol endpoint

Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26

Time frame:Baseline, Week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Once Weekly	-0.00	—
Insulin Glargine	0.01	—

Least Squares Mean Difference-0.0295% CI-0.05 – 0.02p0.377Mixed Models Analysis

Secondary/protocol endpoint

Ratio of Triglycerides at Week 26 to Baseline

Time frame:Baseline, Week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Once Weekly	0.96	—
Insulin Glargine	0.89	—

Geometric Least Squares Mean Ratio1.0795% CI0.99 – 1.15p0.077Mixed Models Analysis

Secondary/protocol endpoint

Change in Blood Pressure From Baseline to Week 26

Time frame:Baseline, Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide Once WeeklySystolic Blood Pressure	-3.03	—
Diastolic Blood Pressure	-1.15	—
Insulin GlargineSystolic Blood Pressure	-0.63	—
Diastolic Blood Pressure	-0.72	—

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes

Time frame:Baseline to Week 26

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), rate per subject-year	95% CI
Exenatide Once Weekly With SUMajor Hypoglycemia	0.00	—
Minor Hypoglycemia	1.14	—
Insulin Glargine With SUMajor Hypoglycemia	0.03	—
Minor Hypoglycemia	2.66	—
Exenatide Once Weekly No SUMajor Hypoglycemia	0.01	—
Minor Hypoglycemia	0.10	—
Insulin Glargine No SUMajor Hypoglycemia	0.01	—
Minor Hypoglycemia	0.63	—

Publications (7)

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

Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 Jul (month)PMID32306296doi:10.1007/s13300-020-00815-zvia clinicaltrials gov reference derived + pubmed nct search
Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial.
The lancet. Diabetes & endocrinology2014 Jun (month)PMID24731672doi:10.1016/S2213-8587(14)70029-4via clinicaltrials gov reference derived + pubmed nct search
Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials.
Postgraduate medicine2013 May (month)PMID23748506doi:10.3810/pgm.2013.05.2660via clinicaltrials gov reference derived + pubmed nct search
Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals.
Cardiovascular diabetology2013 Mar 23PMID23522121doi:10.1186/1475-2840-12-48via clinicaltrials gov reference derived + pubmed nct search
Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.
Diabetes, obesity & metabolism2012 Jun (month)PMID22236356doi:10.1111/j.1463-1326.2012.01561.xvia clinicaltrials gov reference derived + pubmed nct search
Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks.
Diabetes care2012 Apr (month)PMID22357185doi:10.2337/dc11-1233via CT.gov reference
Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial.
Lancet (London, England)2010 Jun 26PMID20609969doi:10.1016/S0140-6736(10)60406-0via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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