Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

This study has been completed.

First Received: June 6, 2002 Last Updated: November 5, 2007 History of Changes

Sponsor:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00039013

Purpose

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (metformin) throughout the study.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: AC2993 (synthetic exendin-4)	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with Type 2 diabetes mellitus
Treated with metformin within a defined dose range for at least 3 months prior to screening
BMI= 27-45 kg/m2
HbA1c value between 7.5% and 11%

Exclusion Criteria:

Treated with oral anti-diabetic medications other than metformin within 3 months of screening
Patients treated previously with AC2993
Patients presently treated with insulin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039013

Show 129 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	2993-112
Study First Received:	June 6, 2002
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00039013 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009