GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

235

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 7.5-10%

Primary endpoint

•Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg) (HbA1c <7.0% achievement, Body weight, absolute change (kg))

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 IDNCT00360334

Org study IDH8O-BP-GWBG

Timeline

Milestones

Study first posted2006-08-04estimated

Results first posted2009-06-05estimated

Last update posted2015-04-07estimated

Study start2006-06 (month precision)

Primary completion2008-04actual (month precision)

Study completion2008-04actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes

•Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.

•HbA1c between 7.5% and 10.0%.

•BMI >27.

Exclusion criteria

•Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.

•Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.

•Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months.

•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.

Endpoints (28)

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

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

7 endpoints

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:26 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg/m^2	95% CI
ExenatideBaseline (Week 0)	34.49	—
Change at endpoint (Week 26)	-0.95	—
Insulin GlargineBaseline (Week 0)	33.71	—
Change at endpoint (Week 26)	1.01	—

p<0.001Mixed Model Repeated Measures

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:26 Weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
ExenatideBaseline (Week 0)	112.07	—
Change at endpoint (Week 26)	-2.19	—
Insulin GlargineBaseline (Week 0)	110.64	—
Change at endpoint (Week 26)	1.97	—

p<0.001Mixed Model Repeated Measures

Secondary/protocol endpoint

Change in Waist-to-hip Ratio

Time frame:26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Ratio	95% CI
ExenatideBaseline (Week 0)	0.99	—
Change at endpoint (Week 26)	-0.02	—
Insulin GlargineBaseline (Week 0)	0.98	—
Change at endpoint (Week 26)	0.01	—

p<0.001Mixed Model Repeated Measures

Secondary/protocol endpoint

Change in Body Weight

Time frame:26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
ExenatideBaseline (Week 0)	101.19	—
Change at endpoint (Week 26)	-2.73	—
Insulin GlargineBaseline (Week 0)	97.93	—
Change at endpoint (Week 26)	2.98	—

p<0.001Mixed Model Repeated Measures

Secondary/protocol endpoint

Percent Change in Body Weight

Time frame:26 Weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage	95% CI
Exenatide	-2.8	—
Insulin Glargine	3.1	—

p<0.001Mixed Models Repeated Measures

Secondary/protocol endpoint

Percent of Patients Achieving 5% Weight Loss

Time frame:26 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide	19.5	—
Insulin Glargine	0.9	—

Odds Ratio (OR)27.9195% CI3.70 – 210.54p0.001Regression, Logistic

Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome

Secondary/protocol endpoint

Percent of Patients Achieving 10% Weight Loss

Time frame:26 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide	4.2	—
Insulin Glargine	0.0	—

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)

Time frame:26 weeks

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg)

Posted result

Group	Value (number), percentage of participants	95% CI
Exenatide	53.4	—
Insulin Glargine	19.8	—

Odds Ratio (OR)4.7195% CI2.62 – 8.46p<0.001Regression, Logistic

Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the primary outcome divided by the odds of a patient in the insulin glargine arm achieving the primary outcome

Secondary/protocol endpoint/low confidence

Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg

Time frame:26 weeks

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg)

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide	52.5	—
Insulin Glargine	16.4	—

Odds Ratio (OR)5.7695% CI3.11 – 10.64p<0.001Regression, Logistic

Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome

Secondary/protocol endpoint

Change in Fasting Serum Glucose

Time frame:26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide	-2.12	—
Insulin Glargine	-3.61	—

p<0.001ANCOVA

Secondary/protocol endpoint

Percent of Patients Achieving HbA1c ≤ 7.4%

Time frame:26 weeks

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Exenatide	54.2	—
Insulin Glargine	61.2	—

Odds Ratio (OR)0.7595% CI0.44 – 1.26p0.280Regression, Logistic

Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome

Secondary/protocol endpoint

Percent 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	34.7	—
Insulin Glargine	43.1	—

Odds Ratio (OR)0.7095% CI0.42 – 1.19p0.191Regression, Logistic

Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome

Secondary/protocol endpoint

Percent 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	15.3	—
Insulin Glargine	11.2	—

Odds Ratio (OR)1.4395% CI0.66 – 3.07p0.363Regression, Logistic

Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome

Secondary/protocol endpoint

Change in 7 Point Self Monitored Blood Glucose Profile

Time frame:26 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
ExenatidePre-breakfast: Baseline (Week 0)	9.98	—
Pre-breakfast: Change at endpoint (Week 26)	-2.01	—
2 hrs after breakfast: Baseline (Week 0)	13.53	—
2 hrs after breakfast: Change at endpt (Week 26)	-5.09	—
Pre-lunch: Baseline (Week 0)	9.95	—
Pre-lunch: Change at endpoint (Week 26)	-2.21	—
2 hrs after lunch: Baseline (Week 0)	12.07	—
2 hrs after lunch: Change at endpoint (Week 26)	-3.20	—
Pre-dinner: Baseline (Week 0)	9.95	—
Pre-dinner: Change at endpoint (Week 26)	-2.13	—
2 hrs after dinner: Baseline (Week 0)	12.59	—
2 hrs after dinner: Change at endpoint (Week 26)	-4.59	—
Bedtime: Baseline (Week 0)	11.63	—
Bedtime: Change at endpoint (Week 26)	-3.56	—
Insulin GlarginePre-breakfast: Baseline (Week 0)	9.88	—
Pre-breakfast: Change at endpoint (Week 26)	-3.99	—
2 hrs after breakfast: Baseline (Week 0)	13.33	—
2 hrs after breakfast: Change at endpt (Week 26)	-3.95	—
Pre-lunch: Baseline (Week 0)	9.54	—
Pre-lunch: Change at endpoint (Week 26)	-2.59	—
2 hrs after lunch: Baseline (Week 0)	11.15	—
2 hrs after lunch: Change at endpoint (Week 26)	-2.48	—
Pre-dinner: Baseline (Week 0)	9.37	—
Pre-dinner: Change at endpoint (Week 26)	-1.46	—
2 hrs after dinner: Baseline (Week 0)	11.80	—
2 hrs after dinner: Change at endpoint (Week 26)	-2.06	—
Bedtime: Baseline (Week 0)	11.24	—
Bedtime: Change at endpoint (Week 26)	-2.20	—

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
ExenatideBaseline (Week 0)	134.0	—
Change at endpoint (Week 26)	-3.6	—
Insulin GlargineBaseline (Week 0)	134.7	—
Change at endpoint (Week 26)	0.6	—

p0.014Mixed Model Repeated Measures

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
ExenatideBaseline (Week 0)	79.6	—
Change at endpoint (Week 26)	-0.8	—
Insulin GlargineBaseline (Week 0)	79.7	—
Change at endpoint (Week 26)	0.9	—

p0.100Mixed Model Repeated Measures

Secondary/protocol endpoint

Change in Fasting Serum Total Cholesterol (TC)

Time frame:26 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide	-0.36	—
Insulin Glargine	-0.21	—

p0.125ANCOVA

Secondary/protocol endpoint

Change in High Density Lipoprotein (HDL) Cholesterol

Time frame:26 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide	0.01	—
Insulin Glargine	0.02	—

p0.471ANCOVA

Secondary/protocol endpoint

Change in TC to HDL Cholesterol Ratio

Time frame:26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Ratio	95% CI
Exenatide	-0.40	—
Insulin Glargine	-0.34	—

p0.601ANCOVA

Secondary/protocol endpoint

Change in Fasting Serum Triglycerides

Time frame:26 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide	-0.33	—
Insulin Glargine	-0.38	—

p0.650ANCOVA

Secondary/protocol endpoint

Change in Low Density Lipoprotein (LDL) Cholesterol

Time frame:26 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Exenatide	-0.25	—
Insulin Glargine	-0.07	—

p0.017ANCOVA

Secondary/protocol endpoint

Change in Apolipoprotein-B

Time frame:26 weeks

ApoB, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), g/L	95% CI
Exenatide	-0.09	—
Insulin Glargine	-0.08	—

p0.667ANCOVA

Safety / tolerability / PK

6 endpoints

Secondary/protocol endpoint

Incidence of Hypoglycemic Episodes

Time frame:26 weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percent	95% CI
Exenatide	50.0	—
Insulin Glargine	59.6	—

Odds Ratio (OR)0.67595% CI0.401 – 1.136p0.139Regression, Logistic

Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome

Secondary/protocol endpoint

Incidence of Nocturnal Hypoglycemic Episodes

Time frame:26 weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percent	95% CI
Exenatide	11.9	—
Insulin Glargine	29.8	—

Odds Ratio (OR)0.31795% CI0.159 – 0.630p0.001Regression, Logistic

Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome

Secondary/protocol endpoint

Incidence of Severe Hypoglycemic Episodes

Time frame:26 weeks

Severe hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percent	95% CI
Exenatide	4.2	—
Insulin Glargine	5.3	—

Odds Ratio (OR)0.79795% CI0.235 – 2.705p0.716Regression, Logistic

Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome

Secondary/protocol endpoint

Hypoglycemic Rate Per 30 Days

Time frame:26 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (median), Number of episodes per 30 days	95% CI
Exenatide	0.069	0.000 – 0.495
Insulin Glargine	0.164	0.000 – 0.686

p0.113ANCOVA on ranks

Secondary/protocol endpoint

Nocturnal Hypoglycemic Rate Per 30 Days

Time frame:26 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (median), Number of episodes per 30 days	95% CI
Exenatide	0.000	0.000 – 0.000
Insulin Glargine	0.000	0.000 – 0.163

p<0.001ANCOVA on ranks

Secondary/protocol endpoint

Severe Hypoglycemic Rate Per 30 Days

Time frame:26 weeks

Severe hypoglycemia

event count, event

Posted result

Group	Value (median), Number of episodes per 30 days	95% CI
Exenatide	0.000	0.000 – 0.989
Insulin Glargine	0.000	0.000 – 0.328

p0.740ANCOVA on ranks

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
Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study.
Diabetes, obesity & metabolism2009 Dec (month)PMID19930005doi:10.1111/j.1463-1326.2009.01154.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.