GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-40•HbA1c 6.6-9.5%

Primary endpoint

•Beta-cell Function After 52 Weeks of Therapy

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 IDNCT00097500

Org study ID2993-114

Timeline

Milestones

Study first posted2004-11-25estimated

Results first posted2011-01-10estimated

Last update posted2015-04-07estimated

Study start2004-09 (month precision)

Primary completion2009-12actual (month precision)

Study completion2009-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of type 2 diabetes, but otherwise healthy

•HbA1c between 6.6% and 9.5%, inclusive.

•Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.

•Treated with a stable dose of metformin for at least 2 months prior to screening.

Exclusion criteria

•Patients previously in a study using exenatide.

•Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).

•Treated with insulin within 3 months of screening.

Endpoints (9)

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

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight

Time frame:0 weeks and 52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide Arm	-3.80	—
Insulin Glargine Arm	0.75	—

p<0.0001ANCOVA

Glycemic / diabetes

8 endpoints

Primary/protocol endpoint/low confidence

Beta-cell Function After 52 Weeks of Therapy

Time frame:Baseline (week -2) and 52 weeks

ratio, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Arm	2.89	—
Insulin Glargine Arm	1.15	—

p0.0001ANCOVA

Secondary/protocol endpoint

Beta-cell Function 4 Weeks After Cessation of Therapy

Time frame:Baseline (week -2) and 56 weeks

ratio, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Arm	1.02	—
Insulin Glargine Arm	1.08	—

p0.4185ANCOVA

Secondary/protocol endpoint

Change in First Phase C-peptide Release

Time frame:baseline (week -2), 52 weeks, and 56 weeks

ratio, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Arm52 weeks	1.72	—
56 weeks	0.95	—
Insulin Glargine Arm52 weeks	1.13	—
56 weeks	1.06	—

p<0.0001ANCOVA

Statistical analysis at week 52.

p0.1188ANCOVA

Statistical analysis at week 56.

Secondary/protocol endpoint

Change in Second Phase C-peptide Release

Time frame:baseline (-2 weeks), 52 weeks, and 56 weeks

C-peptide AUC

ratio, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Arm52 weeks	2.88	—
56 weeks	1.00	—
Insulin Glargine Arm52 weeks	1.01	—
56 weeks	1.08	—

p<0.0001ANCOVA

Statistical analysis at week 52.

p0.1996ANCOVA

Statistical analysis at week 56.

Secondary/protocol endpoint

Change in Glycosylated Hemoglobin (HbA1c)

Time frame:Week 0 and week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percent	95% CI
Exenatide Arm	-0.97	—
Insulin Glargine Arm	-0.87	—

p0.5522ANCOVA

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:0 weeks and 52 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Arm	-1.53	—
Insulin Glargine Arm	-3.10	—

p<0.0001ANCOVA

Secondary/protocol endpoint

Seven Point Self Monitored Blood Glucose (SMBG) Measurements

Time frame:0 weeks and 52 weeks

descriptive, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Exenatide ArmPre-breakfast measurement (week 0)	8.92	—
Pre-breakfast measurement (week 52)	7.27	—
2-hour post-breakfast measurement (week 0)	11.00	—
2-hour post-breakfast measurement (week 52)	6.98	—
Pre-lunch measurement (week 0)	8.14	—
Pre-lunch measurement (week 52)	6.52	—
2-hour post-lunch measurement (week 0)	9.90	—
2-hour post-lunch measurement (week 52)	7.97	—
Pre-dinner measurement (week 0)	8.38	—
Pre-dinner measurement (week 52)	7.53	—
2-hour post-dinner measurement (week 0)	10.42	—
2-hour post-dinner measurement (week 52)	6.98	—
Bedtime measurement (week 0)	9.76	—
Bedtime measurement (week 52)	7.61	—
Insulin Glargine ArmPre-breakfast measurement (week 0)	8.38	—
Pre-breakfast measurement (week 52)	5.63	—
2-hour post-breakfast measurement (week 0)	11.17	—
2-hour post-breakfast measurement (week 52)	7.53	—
Pre-lunch measurement (week 0)	8.54	—
Pre-lunch measurement (week 52)	6.24	—
2-hour post-lunch measurement (week 0)	10.52	—
2-hour post-lunch measurement (week 52)	8.15	—
Pre-dinner measurement (week 0)	8.07	—
Pre-dinner measurement (week 52)	6.98	—
2-hour post-dinner measurement (week 0)	10.26	—
2-hour post-dinner measurement (week 52)	8.81	—
Bedtime measurement (week 0)	9.85	—
Bedtime measurement (week 52)	8.03	—

Secondary/protocol endpoint

M-value at Baseline, Week 52 and Week 56

Time frame:baseline (week -2), 52 weeks, and 56 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), mg/min/kg	95% CI
Exenatide Armbaseline (week -2)	2.24	—
week 52	3.18	—
week 56	3.19	—
Insulin Glargine Armbaseline (week -2)	2.79	—
week 52	3.85	—
week 56	2.81	—

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

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial.
Diabetes research and clinical practice2019 Jul (month)PMID31078666doi:10.1016/j.diabres.2019.05.001via clinicaltrials gov reference derived + pubmed nct search
Effects of exenatide on measures of β-cell function after 3 years in metformin-treated patients with type 2 diabetes.
Diabetes care2011 Sep (month)PMID21868779doi:10.2337/dc11-0291via clinicaltrials gov reference derived + pubmed nct search
One-year treatment with exenatide vs. insulin glargine: effects on postprandial glycemia, lipid profiles, and oxidative stress.
Atherosclerosis2010 Sep (month)PMID20494360doi:10.1016/j.atherosclerosis.2010.04.024via clinicaltrials gov reference derived + pubmed nct search
One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial.
Diabetes care2009 May (month)PMID19196887doi:10.2337/dc08-1797via 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.