Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

This study has been completed.

First Received on September 3, 2002. 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:	NCT00044668

Purpose

This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Study to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety of AC2993 Given Two Times a Day to Subjects With Type 2 Diabetes Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination

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:

*Examine long-term effect on glucose control of subcutaneously (SC) injected AC2993 administered twice a day (BID) in subjects with type 2 diabetes (T2DM);*Assess long-term safety of SC injected AC2993 administered BID in subjects with T2DM

Secondary Outcome Measures:

*Examine long-term effect on various pharmacodynamic measurements of SC injected AC2993 administered BID in subjects with T2DM.

Estimated Enrollment:	150
Study Start Date:	August 2002

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with type 2 diabetes
Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination
BMI 25-45 kg/m^2
HbA1c between 7.5 % and 12.0 %, inclusive

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044668

Locations

Hungary
Peterfy Teaching Hospital
Budapest, Hungary, H 1076
Diagnostic Units Hungary Kft.
Budapest, Hungary, H 1036
Uzsoki Street Municipal Hospital
Budapest, Hungary, H 1145

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00044668 History of Changes
Other Study ID Numbers:	2993-117
Study First Received:	September 3, 2002
Last Updated:	November 5, 2007
Health Authority:	United States: Food and Drug Administration; Hungary: National Institute of Pharmacy

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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012