Full Text View
Tabular View
No Study Results Posted
Related Studies
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
This study has been completed.
First Received: May 7, 2002   Last Updated: November 5, 2007   History of Changes
Sponsored by: Amylin Pharmaceuticals, Inc.
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00035984
  Purpose

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.


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

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035984

  Show 100 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Study ID Numbers: 2993-115
Study First Received: May 7, 2002
Last Updated: November 5, 2007
ClinicalTrials.gov Identifier: NCT00035984     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Hypoglycemic Agents
Metabolic Diseases
Exenatide
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009