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

Tracking Information
First Received Date ^ICMJE	May 7, 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 NCT00035984 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
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 medications (metformin and a sulfonylurea) 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 both metformin and a sulfonylurea at defined doses 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 and sulfonylurea 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	NCT00035984
Responsible Party
Study ID Numbers ^ICMJE	2993-115
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