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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00044668
First received: September 3, 2002
Last updated: September 18, 2013
Last verified: September 2013

September 3, 2002
September 18, 2013
August 2002
September 2005   (final data collection date for primary outcome measure)
  • Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24, Week 52, and to each intermediate visit [ Time Frame: Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]
    Change in HbA1c from Baseline to Week 24, Week 52, and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
  • Change 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 [ Time Frame: Baseline, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ] [ Designated as safety issue: No ]
    Change in concentrations of fasting plasma glucose and lipids from Baseline Visit 2 (Day 1) to Visit 10 (Week 24), to Visit 14 (Week 52) and to each intermediate visit (Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
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Complete list of historical versions of study NCT00044668 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
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 Name: synthetic exendin-4
Experimental: AC2993
5 μg AC2993, twice daily, for 4 weeks followed by 10 μg AC2993, twice daily, during a maintenance period
Intervention: Drug: AC2993
Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
September 2005
September 2005   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT00044668
2993-117
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Eli Lilly and Company
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
Bristol-Myers Squibb
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP