GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

427

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 18-35•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 IDNCT00935532

Org study IDH8O-JE-GWBX

Timeline

Milestones

Study first posted2009-07-09estimated

Results first posted2012-10-24estimated

Last update posted2015-06-15estimated

Study start2009-07 (month precision)

Primary completion2010-09actual (month precision)

Study completion2011-07actual (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

•present with type 2 diabetes mellitus

•HbA1c between 7.1% and 11.0% inclusive

•body mass index (BMI) of >18kg/m2 and <35kg/m2, inclusive

•treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start

Exclusion criteria

•Have received chronic (>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.

•Have been treated with drugs that promote weight loss within 90 days prior to study start.

•Have been treated with drugs that directly affect gastrointestinal motility for > 21 consecutive days within 90 days prior to study start.

•Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).

•Have been treated for >2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs

•Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.

•Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.

•Have donated blood within 30 days prior to study start.

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

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight From Baseline to Endpoint (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	-1.67	—
Insulin Glargine	0.34	—

Least Squares Mean Difference-2.0195% CI-2.46 – -1.56p<.001ANCOVA

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change in HbA1c From Baseline to Endpoint (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	-1.11	—
Insulin Glargine	-0.68	—

Least Squares Mean Difference-0.4395% CI-0.59 – -0.26p<.001ANCOVA

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c<=7%

Time frame:Baseline, 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	42.2	—
Insulin Glargine	21.0	—

p<.001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Percentage of Subjects Achieving HbA1c<=6.5%

Time frame:Baseline, 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	20.6	—
Insulin Glargine	4.2	—

p<.001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (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	-46.09	—
Insulin Glargine	-40.82	—

Least Squares Mean Difference-5.2895% CI-11.62 – 1.07p0.103ANCOVA

Change in FSG from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline FSG as a covariate.

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change in Total Cholesterol From Baseline to Endpoint (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	-14.21	—
Insulin Glargine	-6.32	—

Least Squares Mean Difference-7.8995% CI-12.33 – -3.45p<.001ANCOVA

Secondary/protocol endpoint

Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (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	-0.99	—
Insulin Glargine	-0.71	—

Least Squares Mean Difference-0.2895% CI-1.64 – 1.09p0.689ANCOVA

Secondary/protocol endpoint

Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline

Time frame:Baseline, Week 26

Triglycerides, change

ratio, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Once Weekly	1.00	—
Insulin Glargine	1.00	—

Geometric Least Squares Mean Ratio1.0095% CI0.94 – 1.06p0.990ANCOVA

Secondary/protocol endpoint

Change in Blood Pressure From Baseline to Endpoint (Week 26)

Time frame:Baseline, Week 26

change from baseline, improvement

Posted result

Group	Value (mean), mmHg	95% CI
Exenatide Once WeeklySystolic Blood Pressure	-4.5	—
Diastolic Blood Pressure	-1.1	—
Insulin GlargineSystolic Blood Pressure	-2.6	—
Diastolic Blood Pressure	-2.5	—

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	—
Insulin Glargine	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	0.01	—
Insulin Glargine	0.16	—

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 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 safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study.
Clinical therapeutics2012 Sep (month)PMID22884767doi:10.1016/j.clinthera.2012.07.007via 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.