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: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: AC2993 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Lisa Porter, MD, Study Director, Affiliation: Amylin Pharmaceuticals, LLC.
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visitChange in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Week 24, to Week 52, and to each intermediate visit
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
Diagnostic Units Hungary Kft., Budapest H 1036, Hungary
Peterfy Teaching Hospital, Budapest H 1076, Hungary
Uzsoki Street Municipal Hospital, Budapest H 1145, Hungary
Additional Information
Starting date: August 2002
Last updated: February 19, 2015
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