GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

514

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 IDNCT00637273

Org study IDBCB106 (DURATION - 2)

Timeline

Milestones

Study first posted2008-03-17estimated

Results first posted2012-06-19estimated

Last update posted2015-04-07estimated

Study start2008-01 (month precision)

Primary completion2009-02actual (month precision)

Study completion2009-07actual (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 been diagnosed with type 2 diabetes mellitus

•Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start

•Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start

•Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start

•Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:

1. Hormone replacement therapy (female subjects)

2. Oral contraceptives (female subjects)

3. Antihypertensive agents

4. Lipid-lowering agents

5. Thyroid replacement therapy

6. Antidepressant agents

7. Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents

Exclusion criteria

•Has been previously exposed to exenatide once weekly

•Has donated blood within 60 days of study start or is planning to donate blood during the study

•Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:

1. Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start

2. Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start

3. Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start

4. Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption

5. Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin

•Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start

•Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use

Endpoints (12)

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 From Baseline to Week 26

Time frame:Day 1, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide Once Weekly	-2.31	—
Sitagliptin	-0.77	—
Pioglitazone	2.79	—

Least Squares Mean Difference1.5495% CI0.72 – 2.35p0.0002ANCOVA

Least Squares Mean Difference5.1095% CI4.28 – 5.91p<.0001ANCOVA

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change in HbA1c From Baseline to Week 26

Time frame:Day 1, 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	-1.55	—
Sitagliptin	-0.92	—
Pioglitazone	-1.23	—

Least Squares Mean Difference0.6395% CI0.37 – 0.89p<.0001ANOVA

Least Squares Mean Difference0.3295% CI0.06 – 0.57p0.0165ANOVA

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of <7% at Week 26

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly	58.8	—
Sitagliptin	30.7	—
Pioglitazone	43.6	—

p<.0001Cochran-Mantel-Haenszel

p0.0015Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly	38.8	—
Sitagliptin	15.7	—
Pioglitazone	26.7	—

p<.0001Cochran-Mantel-Haenszel

p0.0120Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26

Time frame:Week 26

HbA1c <6.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly	13.8	—
Sitagliptin	9.0	—
Pioglitazone	4.8	—

p0.1700Cochran-Mantel-Haenszel

p0.0091Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Change in Fasting Plasma Glucose From Baseline to Week 26

Time frame:Day 1, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly	-31.8	—
Sitagliptin	-16.3	—
Pioglitazone	-27.3	—

Least Squares Mean Difference15.595% CI5.7 – 25.2p0.0038ANCOVA

Least Squares Mean Difference4.495% CI-5.3 – 14.2p0.3729ANCOVA

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Change in Systolic Blood Pressure From Baseline to Week 26

Time frame:Day 1, 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	-3.6	—
Sitagliptin	0.2	—
Pioglitazone	-1.6	—

Least Squares Mean Difference3.895% CI1.3 – 6.3p0.0055ANCOVA

Least Squares Mean Difference2.095% CI-0.5 – 4.5p0.1117ANCOVA

Secondary/protocol endpoint

Change in Diastolic Blood Pressure From Baseline to Week 26

Time frame:Day 1, 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	-1.4	—
Sitagliptin	-0.4	—
Pioglitazone	-2.5	—

Least Squares Mean Difference1.095% CI-0.4 – 2.5p0.1685ANCOVA

Least Squares Mean Difference-1.195% CI-2.6 – 0.4p0.1685ANCOVA

Secondary/protocol endpoint

Change in Fasting Total Cholesterol From Baseline to Week 26

Time frame:Day 1, Week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly	-0.6	—
Sitagliptin	3.1	—
Pioglitazone	6.2	—

Least Squares Mean Difference3.795% CI-2.8 – 10.2p0.2686ANCOVA

Least Squares Mean Difference6.895% CI0.3 – 13.2p0.0814ANCOVA

Secondary/protocol endpoint

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

Time frame:Day 1, Week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly	2.0	—
Sitagliptin	2.0	—
Pioglitazone	6.2	—

Least Squares Mean Difference-0.095% CI-1.6 – 1.5p0.9546ANCOVA

Least Squares Mean Difference4.295% CI2.6 – 5.7p<.0001ANCOVA

Secondary/protocol endpoint

Ratio of Fasting Triglycerides at Week 26 to Baseline

Time frame:Day 1, Week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Once Weekly	0.95	—
Sitagliptin	0.95	—
Pioglitazone	0.84	—

Geometric Least Squares Mean Ratio1.0095% CI0.93 – 1.08p0.9718ANCOVA

Geometric Least Squares Mean Ratio0.8995% CI0.82 – 0.96p0.0062ANCOVA

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Assessment on Event Rate of Treatment-emergent Hypoglycemic Events

Time frame:Day 1 to Week 26

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), rate per subject-year	95% CI
Exenatide Once WeeklyTreatment-Emergent Major Hypoglycemia	0.00	—
Treatment-Emergent Minor Hypoglycemia	0.03	—
SitagliptinTreatment-Emergent Major Hypoglycemia	0.00	—
Treatment-Emergent Minor Hypoglycemia	0.12	—
PioglitazoneTreatment-Emergent Major Hypoglycemia	0.00	—
Treatment-Emergent Minor Hypoglycemia	0.01	—

Publications (8)

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, 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
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
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
Development and validation of the self-management profile for type 2 diabetes (SMP-T2D).
Health and quality of life outcomes2012 Oct 5PMID23039868doi:10.1186/1477-7525-10-125via 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
DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide.
Diabetic medicine : a journal of the British Diabetic Association2011 Jun (month)PMID21434995doi:10.1111/j.1464-5491.2011.03301.xvia clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial.
Lancet (London, England)2010 Aug 7PMID20580422doi:10.1016/S0140-6736(10)60590-9via 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.