Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: exenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00241423

H8O-US-GWAW

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has an HbA1c between 7.0% and 10.0%, inclusive.
• Subject has a body mass index (BMI) >25 kg/m^2 and <50 kg/m^2.
• Subject is on a stable dose of metformin or metformin plus a thiazolidinedione.

Exclusion criteria

• Subject has been treated with any of the following medications: *exogenous insulin for more than 1 week within 3 months of screening, *sulfonylureas or meglitinides within 2 months of screening, *alpha-glucosidase inhibitors within 2 months of screening, *pramlintide acetate injection within 2 months of screening.
• Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Exenatide

Experimental group

Description:

Exenatide and the subject's current oral antidiabetic agent regimen

Treatment:

Drug: exenatide

Placebo

Placebo Comparator group

Description:

Placebo and the subject's current oral antidiabetic agent regimen

Treatment:

Drug: Placebo