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.

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. 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

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide Metformin Metformin hydrochloride Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

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

Study ID Numbers:	2993-117
Study First Received:	September 3, 2002
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00044668
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

Study placed in the following topic categories:

Metabolic Diseases
Exenatide
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

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 January 16, 2009