Status:

COMPLETED

Study of the Safety of Substituting Exenatide for Insulin in Patients Using Insulin and Oral Antidiabetic Agents

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

35-70 years

Phase:

PHASE2

Brief Summary

This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).

Detailed Description

This is an exploratory, multicenter, open-label, 2-arm, parallel trial. Approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy...

Eligibility Criteria

Inclusion

  • Patients have been treated with insulin for \>=3 months up to 12 years.
  • HbA1c \<=10.5%.
  • Body mass index (BMI) between 27 kg/m2 and 40 kg/m2.

Exclusion

  • Patients previously received exenatide or GLP-1 analogs.
  • Patients have been treated for greater than 2 weeks with thiazolidinediones or alpha-glucosidase inhibitors within 3 months prior to screening.

Key Trial Info

Start Date :

February 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2005

Estimated Enrollment :

49 Patients enrolled

Trial Details

Trial ID

NCT00099333

Start Date

February 1 2004

End Date

August 1 2005

Last Update

February 23 2015

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Research Site

Chula Vista, California, United States

2

Research Site

Butte, Montana, United States

3

Research Site

Portland, Oregon, United States

4

Research Site

Nashville, Tennessee, United States