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

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

This study has been completed.

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. 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

MedlinePlus related topics:

Diabetes

Drug Information available for:

Exenatide Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

Link to study results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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.

Study ID Numbers:	H8O-MC-GWAP
First Received:	December 10, 2004
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00099320
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

Study placed in the following topic categories:

Metabolic Diseases

Exenatide

Metformin

Diabetes Mellitus, Type 2

Diabetes Mellitus

2,4-thiazolidinedione

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008