Trial | NCT00044668  Report issue

Title

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
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    exenatide ...

  • Study Participants

    155
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.
Study Started
Aug 31
2002
Primary Completion
Sep 30
2005
Study Completion
Sep 30
2005
Last Update
Feb 20
2015
Estimate

Drug AC2993

Subjects will receive 5 μg AC2993, subcutaneously injected twice daily, for 4 weeks followed by 10 μg AC2993, subcutaneously injected twice daily, during a maintenance period that is expected to continue for at least 11 months.

  • Other names: synthetic exendin-4

AC2993 Experimental

5 μg AC2993, twice daily, for 4 weeks followed by 10 μg AC2993, twice daily, during a maintenance period

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
No Results Posted