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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: exenatide; Drug: Placebo

• Registration Number: NCT00241423
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-17
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-19
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exenatide	exenatide	Exenatide and the subject's current oral antidiabetic agent regimen
Placebo	Placebo	Placebo and the subject's current oral antidiabetic agent regimen

Primary Outcome Measures

Name	Time	Method
Time-averaged serum glucose during a 24-hour period	Every half-hour to hour for 24 hours	Time-averaged serum glucose during a 24-hour period

Secondary Outcome Measures

Name	Time	Method
To compare the effects of exenatide and placebo on serum glucose	Each half-hour to 2 hours for 24 hours	To compare the effects of exenatide and placebo on serum glucose measured as averaged daytime glucose, averaged nighttime glucose, time-averaged postprandial glucose 2 hours after each meal, time-averaged postprandial glucose 4 hours after each meal, 2-hour postprandial glucose averaged across morning and evening meals, and averaged across the three meals, and fluctuation evaluations

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States