GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

106

Recruiting sites

—

Enrollment

820

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 23-45•HbA1c 7.1-11%

Primary endpoints

•HbA1c, change•HbA1c <7.0% achievement

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 IDNCT00676338

Org study IDH8O-MC-GWCH (DURATION - 4)

Timeline

Milestones

Study first posted2008-05-13estimated

Results first posted2012-11-26estimated

Last update posted2015-04-09estimated

Study start2008-11 (month precision)

Primary completion2010-07actual (month precision)

Study completion2011-01actual (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

•have type 2 diabetes and are treated with diet and exercise alone.

•at least 18 years of age.

•HbA1c between 7.1% and 11.0%, inclusive.

•Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.

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

Exclusion criteria

•Have 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

•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 history of severe GI disorder (e.g., gastroparesis)

•Have a history of acute or chronic pancreatitis.

•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 with any antidiabetic agent for more than 7 days within 3 months prior to screening.

•Have had an organ transplant.

•Have previously completed or discontinued study drug in this study, 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 (11)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight 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	-2.04	—
Metformin	-2.00	—
Pioglitazone	1.52	—
Sitagliptin	-0.76	—

Least Squares Mean Difference-0.0495% CI-0.61 – 0.53p0.892Mixed Models Analysis

Least Squares Mean Difference-3.5695% CI-4.21 – -2.90p<.001Mixed Models Analysis

Least Squares Mean Difference-1.2895% CI-1.92 – -0.63p<.001Mixed Models Analysis

Glycemic / diabetes

3 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	-1.53	—
Metformin	-1.48	—
Pioglitazone	-1.63	—
Sitagliptin	-1.15	—

Least Squares Mean Difference-0.0598.3% CI-0.26 – 0.17p0.620Mixed Models Analysis

Least Squares Mean Difference0.1098.3% CI-0.15 – 0.35p0.328Mixed Models Analysis

Least Squares Mean Difference-0.3798.3% CI-0.62 – -0.13p<.001Mixed Models Analysis

Primary/protocol endpoint

Percentage of Patients Achieving HbA1c <=7% 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	64.2	—
Metformin	57.3	—
Pioglitazone	63.3	—
Sitagliptin	45.5	—

p0.151Fisher Exact

p0.913Fisher Exact

p<.001Fisher Exact

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	-2.25	—
Metformin	-1.98	—
Pioglitazone	-2.57	—
Sitagliptin	-1.13	—

Least Squares Mean Difference-0.2895% CI-0.66 – 0.10p0.155Mixed Models Analysis

Least Squares Mean Difference0.3295% CI-0.12 – 0.75p0.153Mixed Models Analysis

Least Squares Mean Difference-1.1295% CI-1.56 – -0.68p<.001Mixed Models Analysis

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Change in Fasting Total Cholesterol (TC) 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	-0.24	—
Metformin	-0.22	—
Pioglitazone	0.09	—
Sitagliptin	-0.01	—

Least Squares Mean Difference-0.0195% CI-0.18 – 0.15p0.873Mixed Models Analysis

Least Squares Mean Difference-0.3395% CI-0.52 – -0.14p<.001Mixed Models Analysis

Least Squares Mean Difference-0.2295% CI-0.41 – -0.03p0.022Mixed Models Analysis

Secondary/protocol endpoint

Change in Fasting High-Density Lipoprotein (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	0.01	—
Metformin	0.07	—
Pioglitazone	0.17	—
Sitagliptin	0.04	—

Least Squares Mean Difference-0.0595% CI-0.09 – -0.02p0.004Mixed Models Analysis

Least Squares Mean Difference-0.1595% CI-0.19 – -0.11p<.001Mixed Models Analysis

Least Squares Mean Difference-0.0395% CI-0.07 – 0.01p0.142Mixed Models Analysis

Secondary/protocol endpoint

Ratio of Fasting 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	0.98	—
Metformin	0.96	—
Pioglitazone	0.85	—
Sitagliptin	0.94	—

Geometric Least Squares Mean Ratio1.0295% CI0.94 – 1.10p0.657ANCOVA

Geometric Least Squares Mean Ratio1.1695% CI1.06 – 1.27p0.002ANCOVA

Geometric Least Squares Mean Ratio1.0495% CI0.95 – 1.14p0.398ANCOVA

Secondary/protocol endpoint

Change in Systolic 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 (least_squares_mean), mmHg	95% CI
Exenatide Once Weekly	-1.25	—
Metformin	0.14	—
Pioglitazone	-1.74	—
Sitagliptin	-1.81	—

Least Squares Mean Difference-1.3995% CI-3.52 – 0.74p0.201Mixed Models Analysis

Least Squares Mean Difference0.4995% CI-1.94 – 2.93p0.693Mixed Models Analysis

Least Squares Mean Difference0.5695% CI-1.84 – 2.96p0.646Mixed Models Analysis

Secondary/protocol endpoint

Change in Diastolic Blood Pressure From Baseline to Week 26.

Time frame:Baseline, Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exenatide Once Weekly	-0.50	—
Metformin	-0.86	—
Pioglitazone	-2.50	—
Sitagliptin	-0.45	—

Least Squares Mean Difference0.3695% CI-1.02 – 1.73p0.610Mixed Models Analysis

Least Squares Mean Difference2.0095% CI0.43 – 3.58p0.013Mixed Models Analysis

Least Squares Mean Difference-0.0595% CI-1.60 – 1.49p0.946Mixed Models Analysis

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events

Time frame:Baseline to Week 26

Severe hypoglycemia

event count, event

Posted result

Group	Value (mean), events per subject-year	95% CI
Exenatide Once Weekly	0.00	—
Metformin	0.00	—
Pioglitazone	0.00	—
Sitagliptin	0.00	—

Secondary/protocol endpoint

Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events

Time frame:Baseline to Week 26

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), events per subject-year	95% CI
Exenatide Once Weekly	0.05	—
Metformin	0.00	—
Pioglitazone	0.00	—
Sitagliptin	0.00	—

Publications (5)

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
Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data.
Postgraduate medicine2013 May (month)PMID23748507doi:10.3810/pgm.2013.05.2661via 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
Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study.
Diabetes care2012 Feb (month)PMID22210563doi:10.2337/dc11-1107via 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.