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

Tracking Information
First Received Date ^ICMJE	June 6, 2002
Last Updated Date	November 5, 2007
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00039013 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
Official Title ^ICMJE
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel 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
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	16 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00039013
Responsible Party
Study ID Numbers ^ICMJE	2993-112
Study Sponsor ^ICMJE	Amylin Pharmaceuticals, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
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