Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00044694
First received: September 3, 2002
Last updated: September 18, 2013
Last verified: September 2013

September 3, 2002
September 18, 2013
August 2002
May 2003   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 [ Time Frame: Baseline (Day 1) to Day 28 ] [ Designated as safety issue: No ]
Change in HbA1c from Baseline (Day 1) to study termination (Day 28)
Not Provided
Complete list of historical versions of study NCT00044694 on ClinicalTrials.gov Archive Site
  • Change in HbA1c from Baseline to Day 14 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    Change in HbA1c from Baseline (Day 1) to Day 14
  • Change in fasting plasma glucose from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day28 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)
  • Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day 28 ] [ Designated as safety issue: No ]
    Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
Not Provided
Not Provided
Not Provided
 
Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus

This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Non-Insulin-Dependent
  • Drug: Placebo 0.01 mL
    2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
  • Drug: Placebo 0.02 mL
    2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
  • Drug: Placebo 0.03 mL
    2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
  • Drug: Placebo 0.04 mL
    2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
  • Drug: AC2993 2.5 mcg
    2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily
    Other Name: synthetic exendin-4
  • Drug: AC2993 5.0 mcg
    2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily
    Other Name: synthetic exendin-4
  • Drug: AC2993 7.5 mcg
    2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily
    Other Name: synthetic exendin-4
  • Drug: AC2993 10.0 mcg
    2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily
    Other Name: synthetic exendin-4
  • Placebo Comparator: Placebo 0.01 mL
    2 week placebo lead-in followed by Placebo 0.01 mL
    Intervention: Drug: Placebo 0.01 mL
  • Placebo Comparator: Placebo 0.02 mL
    2 week placebo lead-in followed by Placebo 0.02 mL
    Intervention: Drug: Placebo 0.02 mL
  • Placebo Comparator: Placebo 0.03 mL
    2 week placebo lead-in followed by Placebo 0.03 mL
    Intervention: Drug: Placebo 0.03 mL
  • Placebo Comparator: Placebo 0.04 mL
    2 week placebo lead-in followed by Placebo 0.04 mL
    Intervention: Drug: Placebo 0.04 mL
  • Experimental: AC2993 2.5 mcg
    2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL
    Intervention: Drug: AC2993 2.5 mcg
  • Experimental: AC2993 5.0 mcg
    2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL
    Intervention: Drug: AC2993 5.0 mcg
  • Experimental: AC2993 7.5 mcg
    2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL
    Intervention: Drug: AC2993 7.5 mcg
  • Experimental: AC2993 10.0 mcg
    2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL
    Intervention: Drug: AC2993 10.0 mcg
Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
May 2003
May 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
  • BMI 27-45 kg/m^2
  • HbA1c between 7.0 % and 8.0 %

Exclusion Criteria:

  • Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
  • Patients previously treated with AC2993
  • Patients presently treated with insulin
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00044694
2993-116
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
September 2013

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