Overview

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

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Collaborator:
Eli Lilly and Company
Treatments:
Exenatide
Criteria
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.