GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

A Comparator-Controlled Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control (HbA1c) and Safety in Asian Subjects With Type 2 Diabetes Mellitus Managed With Oral Antidiabetic Medications

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

691

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 21-35•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 IDNCT00917267

Org study IDH8O-MC-GWCK

Timeline

Milestones

Study first posted2009-06-10estimated

Results first posted2012-12-31estimated

Last update posted2015-04-09estimated

Study start2009-07 (month precision)

Primary completion2010-09actual (month precision)

Study completion2011-04actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have been diagnosed with type 2 diabetes.

•Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.

•Have a body mass index (BMI) of >21 kg/m2 and <35 kg/m2, inclusive.

•Have a history of stable body weight (not varying by >5% for at least 90 days prior to study start).

•Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.

Exclusion criteria

•Have any contraindication for the OAD(s) that they use.

•Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.

•Have received chronic >14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.

•Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.

•Have been treated for >2 weeks with any of the following excluded medications within 90 days prior to study start:

–Insulin

–Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)

–Pramlintide acetate

–Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.

•Have had prior exposure to exenatide

•Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.

•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	-1.63	—
Exenatide Twice Daily	-2.45	—

Least Squares Mean Difference0.8295% CI0.39 – 1.25p<.001Mixed Models Analysis

MMRM ANCOVA model includes treatment, baseline BW, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.

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	-1.43	—
Exenatide Twice Daily	-1.12	—

Least Squares Mean Difference-0.3195% CI-0.49 – -0.14p<.001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c Targets <=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	46.7	—
Exenatide Twice Daily	35.7	—

p0.003Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c Targets <=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	26.0	—
Exenatide Twice Daily	15.5	—

p<.001Cochran-Mantel-Haenszel

Percentage of patients achieving HbA1c target \<=6.5% at Week 26 were compared between treatments using a CMH test, in which country and background OAD 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), mg/dL	95% CI
Exenatide Once Weekly	-40.57	—
Exenatide Twice Daily	-23.90	—

Least Squares Mean Difference-16.6795% CI-22.50 – -10.83p<.001Mixed Models Analysis

MMRM ANCOVA model includes treatment, baseline FSG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change in 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), mg/dL	95% CI
Exenatide Once Weekly	-9.41	—
Exenatide Twice Daily	-8.10	—

Least Squares Mean Difference-1.3195% CI-6.33 – 3.71p0.609Mixed Models Analysis

MMRM ANCOVA model includes treatment, baseline TC, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.

Secondary/protocol endpoint

Change in 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), mg/dL	95% CI
Exenatide Once Weekly	-0.11	—
Exenatide Twice Daily	-0.48	—

Least Squares Mean Difference0.3795% CI-0.65 – 1.38p0.476Mixed Models Analysis

MMRM ANCOVA model includes treatment, baseline HDL, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.

Secondary/protocol endpoint

Ratio of Triglycerides (TG) 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	0.97	—
Exenatide Twice Daily	0.97	—

Geometic Least Squares Mean Ratio0.9995% CI0.93 – 1.06p0.807Mixed 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	-5.33	—
Diastolic Blood Pressure	-1.47	—
Exenatide Twice DailySystolic Blood Pressure	-5.22	—
Diastolic Blood Pressure	-2.24	—

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Assessment of Event Rate of Treatment-emergent 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 With SU Use at ScreeningMajor Hypoglycemia	0.00	—
Minor Hypoglycemia	0.24	—
Exenatide Twice Daily With SU Use at ScreeningMajor Hypoglycemia	0.01	—
Minor Hypoglycemia	0.59	—
Exenatide Once Weekly Without SU Use at ScreeningMajor Hypoglycemia	0.00	—
Minor Hypoglycemia	0.03	—
Exenatide Twice Daily Without SU Use at ScreeningMajor Hypoglycemia	0.00	—
Minor Hypoglycemia	0.11	—

Publications (2)

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 of exenatide once weekly for 52 weeks in Japanese patients with type 2 diabetes mellitus.
Journal of diabetes investigation2013 Mar 18PMID24843650doi:10.1111/jdi.12000via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus.
Journal of diabetes investigation2013 Jan 29PMID24843631doi:10.1111/j.2040-1124.2012.00238.xvia 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.