GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

254

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 IDNCT00877890

Org study IDBCB108 (DURATION-5)

Timeline

Milestones

Study first posted2009-04-08estimated

Results first posted2012-06-19estimated

Last update posted2015-04-07estimated

Study start2009-03 (month precision)

Primary completion2009-10actual (month precision)

Study completion2010-01actual (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

•Has been diagnosed with type 2 diabetes mellitus

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

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

•Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening

•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 screening:

–Hormone replacement therapy (female subjects)

–Oral contraceptives (female subjects)

–Antihypertensive agents

–Lipid-lowering agents

–Thyroid replacement therapy

–Antidepressant agents

–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 ever been exposed to exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog

•Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening

•Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:

–Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening

–Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening

–Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening

–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

Endpoints (13)

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

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 24

Time frame:Day 1, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide Once Weekly	-2.33	-3.05 – -1.60
Exenatide Twice Daily	-1.37	-2.13 – -0.61

Least Squares Mean Difference-0.9595% CI-1.91 – 0.01p0.0514ANCOVA

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change in HbA1c From Baseline to Week 24

Time frame:Day 1, Week 24

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	-1.57	-1.77 – -1.36
Exenatide Twice Daily	-0.90	-1.12 – -0.69

Least Squares Mean Difference-0.6795% CI-0.94 – -0.39p<.0001ANOVA

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of <7%

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly	58.1	—
Exenatide Twice Daily	30.1	—

p<.0001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c Target of <=6.5%

Time frame:Week 24

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly	41.1	—
Exenatide Twice Daily	16.3	—

p<.0001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Change in Fasting Plasma Glucose From Baseline to Week 24

Time frame:Day 1, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly	-25.1	-33.6 – -16.6
Exenatide Twice Daily	-4.6	-13.5 – 4.2

Least Squares Mean Difference-20.495% CI-31.4 – -9.5p0.0006ANCOVA

Secondary/protocol endpoint

Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL

Time frame:Week 24

threshold achievement, improvement

LOINC 1558-6

Posted result

Group	Value (number), percentage of subjects	95% CI
Exenatide Once Weekly	50.4	—
Exenatide Twice Daily	30.9	—

p0.0008Cochran-Mantel-Haenszel

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Change in Sitting Systolic Blood Pressure From Baseline to Week 24

Time frame:Day 1, Week 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exenatide Once Weekly	-2.9	-5.2 – -0.7
Exenatide Twice Daily	-1.2	-3.5 – 1.2

Least Squares Mean Difference-1.895% CI-4.7 – 1.2p0.2367ANCOVA

Secondary/protocol endpoint

Change in Sitting Diastolic Blood Pressure From Baseline to Week 24

Time frame:Day 1, Week 24

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Exenatide Once Weekly	0.2	-1.3 – 1.6
Exenatide Twice Daily	-0.1	-1.7 – 1.4

Least Squares Mean Difference0.395% CI-1.7 – 2.2p0.7717ANCOVA

Secondary/protocol endpoint

Change in Total Cholesterol From Baseline to Week 24

Time frame:Day 1, Week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly	-15.4	-20.5 – -10.2
Exenatide Twice Daily	0.6	-4.9 – 6.1

Least Squares Mean Difference-16.095% CI-22.9 – -9.1p<.0001ANCOVA

Secondary/protocol endpoint

Change in High-density Lipoprotein (HDL) From Baseline to Week 24

Time frame:Day 1, Week 24

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Exenatide Once Weekly	0.0	-1.2 – 1.2
Exenatide Twice Daily	1.3	0.0 – 2.5

Least Squares Mean Difference-1.295% CI-2.8 – 0.3p0.1251ANCOVA

Secondary/protocol endpoint

Ratio of Triglycerides at Week 24 to Baseline

Time frame:Day 1, Week 24

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Once Weekly	0.94	0.88 – 1.00
Exenatide Twice Daily	0.99	0.92 – 1.06

Geometric Least Squares Mean Ratio0.9595% CI0.87 – 1.04p0.2558ANCOVA

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events

Time frame:Day 1 to Week 24

Severe hypoglycemia

event count, event

Posted result

Group	Value (mean), rate per subject-year	95% CI
Exenatide Once Weekly With SU	0.00	—
Exenatide Twice Daily With SU	0.00	—
Exenatide Once Weekly No SU	0.00	—
Exenatide Twice Daily No SU	0.00	—

Secondary/protocol endpoint

Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events

Time frame:Day 1 to Week 24

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), rate per subject-year	95% CI
Exenatide Once Weekly With SU	0.75	—
Exenatide Twice Daily With SU	0.31	—
Exenatide Once Weekly No SU	0.00	—
Exenatide Twice Daily No SU	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

Onset of Glycemic and Weight Outcomes in Patients Initiating Exenatide Once Weekly: The Relationship of Exenatide Exposure with Efficacy over the First 24 Weeks of Treatment.
Diabetes therapy : research, treatment and education of diabetes and related disorders2016 Jun (month)PMID27146799doi:10.1007/s13300-016-0172-0via 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
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-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes.
The Journal of clinical endocrinology and metabolism2011 May (month)PMID21307137doi:10.1210/jc.2010-2081via CT.gov reference

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.