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 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 3, 2002

Last Updated Date

November 5, 2007

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

*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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00044668 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: AC2993 (synthetic exendin-4)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Hungary

Administrative Information

NCT ID ^ICMJE

NCT00044668

Responsible Party

Study ID Numbers ^ICMJE

2993-117

Study Sponsor ^ICMJE

Amylin Pharmaceuticals, Inc.

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, Inc.

Information Provided By

Amylin Pharmaceuticals, Inc.

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP