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

This study has been completed.

First Received on December 10, 2004. Last Updated on November 5, 2007 History of Changes

Sponsor:	Amylin Pharmaceuticals, Inc.
Collaborator:	Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00099320

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Exenatide Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

* 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.

Secondary Outcome Measures:

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

Estimated Enrollment:	280
Study Start Date:	May 2004

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099320

Show 51 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

James Malone, MD

Eli Lilly and Company

More Information

No publications provided by Amylin Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00099320 History of Changes
Other Study ID Numbers:	H8O-MC-GWAP
Study First Received:	December 10, 2004
Last Updated:	November 5, 2007
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Spain: Spanish Agency of Medicines

Keywords provided by Amylin Pharmaceuticals, Inc.:

exenatide
exendin-4
diabetes
Amylin
Lilly

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide

2,4-thiazolidinedione
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012