Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin - Tabular View

Tracking Information

First Received Date ^ICMJE

December 10, 2004

Last Updated Date

November 5, 2007

Start Date ^ICMJE

May 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

* To test the hypothesis that glycemic control with exenatide is superior to placebo in patients with type 2 diabetes and inadequate glycemic control taking thiazolidinediones alone or thiazolidinediones and metformin.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00099320 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

* To compare exenatide and placebo groups with respect to various pharmacodynamic measurements and safety and tolerability.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Official Title ^ICMJE

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Brief Summary

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: exenatide

Study Arms / Comparison Groups

Publications *

Zinman B, Hoogwerf BJ, Duran Garcia S, Milton DR, Giaconia JM, Kim DD, Trautmann ME, Brodows RG. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Apr 3;146(7):477-85. Erratum in: Ann Intern Med. 2007 Jun 19;146(12):896. Summary for patients in: Ann Intern Med. 2007 Apr 3;146(7):I18.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

280

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
HbA1c between 7.1% and 10.0%, inclusive.
Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.

Exclusion Criteria:

Patient previously in a study using exenatide or GLP-1 analogs.
Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
Treated with oral insulin within 3 months of screening.

Gender

Both

Ages

21 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Spain

Administrative Information

NCT ID ^ICMJE

NCT00099320

Responsible Party

Study ID Numbers ^ICMJE

H8O-MC-GWAP

Study Sponsor ^ICMJE

Amylin Pharmaceuticals, Inc.

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Study Director:

James Malone, MD

Eli Lilly and Company

Information Provided By

Amylin Pharmaceuticals, Inc.

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP