GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

165

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c 7.1-10%

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 IDNCT00603239

Org study IDH8O-MC-GWCG

Timeline

Milestones

Study first posted2008-01-29estimated

Results first posted2010-09-02estimated

Last update posted2015-04-07estimated

Study start2008-01 (month precision)

Primary completion2009-07actual (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

•Diagnosed with type 2 diabetes

•If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days

•The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)

•The metformin dose has been stable for at least 90 days

•Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.

•Have a body mass index (BMI): 25 kg/m2 < BMI < 45 kg/m2.

Exclusion criteria

•Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs

•Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.

•Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening

•Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.

•Are currently treated with any of the following excluded medications:

–Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening

–Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening

–Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening

–Pramlintide acetate injection within 3 months prior to screening

–Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics

–Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding 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

Weight & body composition

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight

Time frame:baseline and 26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Exenatide Twice Daily (BID)	-1.43	—
Placebo	-0.75	—

p0.176ANCOVA

Null hypothesis = Change from baseline to endpoint in body weight is equal between the two treatment groups.

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:baseline and 26 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Exenatide Twice Daily (BID)	-2.26	—
Placebo	-1.85	—

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Change in Glycosylated Hemoglobin (HbA1c)

Time frame:baseline and 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage	95% CI
Exenatide Twice Daily (BID)	-0.84	—
Placebo	-0.10	—

p<0.001ANCOVA

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <= 7%

Time frame:26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Exenatide Twice Daily (BID)	49.0	—
Placebo	36.5	—

p0.113CMH test

Null hypothesis = Proportion of subjects with HbA1c \<= 7% is equal between the two treatment groups.

Secondary/protocol endpoint

Percentage of Patients Achieving HbA1c <= 6.5%

Time frame:26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Exenatide Twice Daily (BID)	33.6	—
Placebo	13.0	—

p0.004CMH test

Null hypothesis = Proportion of subjects achieving HbA1c \<= 6.5% is equal between the two treatment groups.

Secondary/protocol endpoint

Change in Fasting Serum Glucose (FSG)

Time frame:baseline and 26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide Twice Daily (BID)	-0.65	—
Placebo	0.37	—

p0.009ANCOVA

Null hypothesis = Change from baseline in FSG is equal between the two treatment groups.

Secondary/protocol endpoint

Change in Beta-cell Function

Time frame:baseline and 26 weeks

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Exenatide Twice Daily (BID)	1.08	—
Placebo	0.84	—

p0.009ANCOVA

Null hypothesis = Change form baseline in HOMA-B is equal between the two treatment groups.

Secondary/protocol endpoint

Change in Insulin Sensitivity.

Time frame:baseline and 26 weeks

HOMA-IR (insulin sensitivity)

ratio, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
Exenatide Twice Daily (BID)	1.09	—
Placebo	1.07	—

p0.794ANCOVA

Null hypothesis = Change from baseline in HOMA-S is equal between the two treatment groups.

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score

Time frame:baseline and 26 weeks

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
Exenatide Twice Daily (BID)Change in Total Score	-1.56	—
Change in Physical Function component	-3.84	—
Change in Self-Esteem component	0.20	—
Change in Sexual Life component	0.12	—
Change in Public Distress component	-0.48	—
Change in Work component	-0.91	—
PlaceboChange in Total Score	0.11	—
Change in Physical Function component	-1.05	—
Change in Self-Esteem component	-0.54	—
Change in Sexual Life component	5.01	—
Change in Public Distress component	-0.28	—
Change in Work component	0.08	—

p0.342ANCOVA

Null hypothesis = Change from baseline in IWQOL-Lite Total Score is equal between the two treatment groups. This statistical analysis is for the Total Score only.

Secondary/protocol endpoint

Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score

Time frame:baseline and 26 weeks

EQ-5D index

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	95% CI
Exenatide Twice Daily (BID)Change in Health State Score	0.79	—
Change in Mobility component	0.14	—
Change in Self Care component	0.08	—
Change Usual Activities component	0.17	—
Change in Pain/Discomfort component	0.29	—
Change in Anxiety/Depression component	-0.10	—
PlaceboChange in Health State Score	-2.94	—
Change in Mobility component	0.15	—
Change in Self Care component	0.03	—
Change Usual Activities component	0.19	—
Change in Pain/Discomfort component	0.23	—
Change in Anxiety/Depression component	-0.26	—

p0.186ANCOVA

Null hypothesis = Change from baseline in EQ-5D score is equal between the two treatment groups. This statistical analysis is for the EQ-5D Health State Score only.

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of Subjects Who Experienced an Episode of Minor Hypoglycemia

Time frame:26 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Participants	95% CI
Exenatide Twice Daily (BID)	4	—
Placebo	1	—

p1.00Fisher Exact

Null hypothesis = Incidence of minor hypoglycemia episodes is equal between the two treatment groups.

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

Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index.
Postgraduate medicine2012 Jul (month)PMID22913891doi:10.3810/pgm.2012.07.2567via clinicaltrials gov reference derived + pubmed nct search
A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin.
Diabetes, obesity & metabolism2010 Dec (month)PMID20977576doi:10.1111/j.1463-1326.2010.01251.xvia 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.