CompletedPhase 4Results posted

Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Comparison of the Effect of Exenatide vs. Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 25-45•HbA1c 7-11%

Primary endpoint

•Time-averaged Glucose During a 24 Hour Period

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00729326

Org study IDH8O-US-GWCV

Timeline

Milestones

Study first posted2008-08-07estimated

Results first posted2011-01-20estimated

Last update posted2015-04-09estimated

Study start2008-08 (month precision)

Primary completion2009-10actual (month precision)

Study completion2009-10actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have type 2 diabetes

•Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.

•Have a fasting glucose concentration <280 mg/dL at Visit 1

•Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.

•Are between 18 and 70 years of age, inclusive.

•Have body mass index ≥25 kg/m2 and ≤45 kg/m2.

•Have a history of stable body weight (not varying by >10% for at least 3 months prior to screening).

•Can swallow oral study drug capsule, without splitting or crushing.

Exclusion criteria

•Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:

-Are breastfeeding.

-Test positive for pregnancy at the time of screening.

-Intend to become pregnant during the study.

-Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.

•Treated with any of the following medications:

-Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening

-Alpha-glucosidase inhibitor within 2 months of screening.

-Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.

-Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1.

-Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.

•Have a history of renal transplantation or are currently receiving renal dialysis.

•Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.

•Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.

•Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.

•Have had organ transplantation.

•Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 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 (19)

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

Safety / tolerability / PK

Cardiometabolic biomarkers

Glycemic / diabetes

9 endpoints

Primary/protocol endpoint

Change in Time-averaged Glucose During a 24 Hour Period

Time frame:baseline and 8 Weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · mg/dL	95% CI
Exenatide	-41.65	-
Sitagliptin	-29.56	-

p<.001ANCOVA

Secondary/protocol endpoint

Change in Two-hour Postprandial Glucose After the Morning Meal

Time frame:baseline and 8 Weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Least-squares mean · mg/dL	95% CI
Exenatide	-108.35	-
Sitagliptin	-44.43	-

p<.001ANCOVA

Secondary/protocol endpoint

Change in Fasting Blood Glucose After the Morning Meal

Time frame:baseline and 8 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mg/dL	95% CI
Exenatide	-28.93	-
Sitagliptin	-28.22	-

p.766ANCOVA

Secondary/protocol endpoint

Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal

Time frame:baseline and 8 Weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · pmol*hours/L	95% CI
Exenatide	-29.60	-
Sitagliptin	-16.91	-

p<.001ANCOVA

Secondary/protocol endpoint

Change in Postprandial Glucagon AUC Excursion After the Morning Meal

Time frame:baseline and 8 Weeks

postprandial glucagon auc excursion

change from baseline, improvement

Posted result

Group	Least-squares mean · pmol*hours/L	95% CI
Exenatide	-30.94	-
Sitagliptin	-14.93	-

p<.001ANCOVA

Secondary/protocol endpoint

Change in Postprandial C-peptide AUC After the Morning Meal

Time frame:baseline and 8 Weeks

C-peptide AUC

change from baseline, improvement

Posted result

Group	Least-squares mean · nmol*hours/L	95% CI
Exenatide	-1.78	-
Sitagliptin	0.25	-

p<.001ANCOVA

Secondary/protocol endpoint

Change in Postprandial C-peptide AUC Excursion After the Morning Meal

Time frame:baseline and 8 Weeks

C-peptide AUC

change from baseline, improvement

Posted result

Group	Least-squares mean · nmol*hours/L	95% CI
Exenatide	-2.83	-
Sitagliptin	0.14	-

p<.001ANCOVA

Secondary/protocol endpoint

Change in Postprandial Insulin AUC After the Morning Meal

Time frame:baseline and 8 Weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · pmol*hours/L	95% CI
Exenatide	-396.12	-
Sitagliptin	-8.79	-

p<.001ANCOVA

Secondary/protocol endpoint

Change in Postprandial Insulin AUC Excursion After the Morning Meal

Time frame:baseline and 8 Weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · pmol*hours/L	95% CI
Exenatide	-525.01	-
Sitagliptin	-34.83	-

p<.001ANCOVA

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change in Postprandial Triglyceride AUC After the Morning Meal

Time frame:baseline and 8 Weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Least-squares mean · mg*hours/dL	95% CI
Exenatide	0.83	-
Sitagliptin	0.87	-

p.117ANCOVA

Secondary/protocol endpoint

Change in Postprandial Triglyceride AUC Excursion After the Morning Meal

Time frame:baseline and 8 Weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Least-squares mean · mg*hours/dL	95% CI
Exenatide	-108.16	-
Sitagliptin	-41.39	-

p<.001ANCOVA

Secondary/protocol endpoint

Change in Postprandial Active GLP-1 AUC After the Morning Meal

Time frame:baseline and 8 Weeks

postprandial active glp1 auc

change from baseline, improvement

Posted result

Group	Least-squares mean · pmol*hours/L	95% CI
Exenatide	-14.28	-
Sitagliptin	47.37	-

p<.001ANCOVA

Secondary/protocol endpoint

Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal

Time frame:baseline and 8 Weeks

postprandial active glp1 auc

change from baseline, improvement

Posted result

Group	Least-squares mean · pmol*hours/L	95% CI
Exenatide	-14.04	-
Sitagliptin	23.53	-

p<.001ANCOVA

Safety / tolerability / PK

6 endpoints

Secondary/protocol endpoint

Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)

Time frame:4 Weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Number · Percentage of patients	95% CI
Exenatide	2.9	-
Sitagliptin	2.7	-

Secondary/protocol endpoint

Episodes of Hypoglycemia (Baseline to Week 4)

Time frame:4 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Number · episodes of hypoglycemia	95% CI
Exenatide	1	-
Sitagliptin	1	-

Secondary/protocol endpoint

Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)

Time frame:8 weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Number · Percentage of patients	95% CI
Exenatide	5.7	-
Sitagliptin	0.0	-

Secondary/protocol endpoint

Episodes of Hypoglycemia (Week 4 to Week 8)

Time frame:8 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Number · episodes of hypoglycemia	95% CI
Exenatide	2	-
Sitagliptin	0	-

Secondary/protocol endpoint

Percentage of Patients Experiencing Hypoglycemia (Overall)

Time frame:4 weeks and 8 weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Number · Percentage of patients	95% CI
Exenatide	4.3	-
Sitagliptin	1.4	-

Secondary/protocol endpoint

Episodes of Hypoglycemia (Overall)

Time frame:4 weeks and 8 weeks

event count, event

Posted result

Group	Number · episodes of hypoglycemia	95% CI
Exenatide	3	-
Sitagliptin	1	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.