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
Information source: Amylin Pharmaceuticals, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: AC2993 (synthetic exendin-4) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amylin Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
Lisa Porter, MD, Study Director, Affiliation: Amylin Pharmaceuticals, Inc.
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: *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: *Examine long-term effect on various pharmacodynamic measurements of SC injected AC2993 administered BID in subjects with T2DM.
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Peterfy Teaching Hospital, Budapest H 1076, Hungary
Diagnostic Units Hungary Kft., Budapest H 1036, Hungary
Uzsoki Street Municipal Hospital, Budapest H 1145, Hungary
Additional Information
Link to study results on ClinicalStudyResults.org
Starting date: August 2002
Last updated: November 5, 2007
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