Evaluation of the Effect on Glucose Control 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:
NCT00035984
First received: May 7, 2002
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: AC2993
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Twice Daily in Subjects With Type 2 Diabetes Mellitus Treated With Metformin and a Sulfonylurea

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change in HbA1c from Baseline to Week 30 [ Time Frame: Baseline (Day 1) to Week 30 ] [ Designated as safety issue: No ]
    Change in HbA1c from Baseline (Day 1) to study termination (Week 30)


Secondary Outcome Measures:
  • Change in HbA1c from baseline (Day 1) to each of the intermediate visits [ Time Frame: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24 ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24)

  • The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30 [ Time Frame: Baseline (Day 1) and Week 30 ] [ Designated as safety issue: No ]
    The number of subjects achieving HbA1c target values of < 7% and < 8% by study termination (Week 30)

  • The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30 [ Time Frame: Baseline (Day 1), and Week 30 ] [ Designated as safety issue: No ]
    The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by study termination (Week 30)

  • The time to achieve specific HbA1c target values of < 7% and < 8% [ Time Frame: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30 ] [ Designated as safety issue: No ]
    The time it takes subjects to achieve HbA1c target values of < 7% and < 8%

  • The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more [ Time Frame: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30 ] [ Designated as safety issue: No ]
    The time it takes subjects to achieve HbA1c reductions of 0.5% or more and >1.0% or more

  • Change in body weight from Baseline to each intermediate visit and Week 30 [ Time Frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30 ] [ Designated as safety issue: No ]
    Change in body weight (kg) from Baseline to each intermediate visit and Week 30


Enrollment: 734
Study Start Date: May 2002
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AC2993 5 mcg (0.02 mL)
Placebo, then AC2993 5 mcg, then AC2993 5 mcg
Drug: AC2993
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Other Name: synthetic exendin-4
Experimental: AC2993 10mcg (0.04 mL)
Placebo, then AC2993 5 mcg, then AC2993 10 mcg
Drug: AC2993
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
Other Name: synthetic exendin-4
Placebo Comparator: Placebo 0.02 mL
Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL
Drug: Placebo
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Placebo Comparator: Placebo 0.04 mL
Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL
Drug: Placebo
Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with Type 2 diabetes mellitus
  • Treated with both metformin and a sulfonylurea at defined doses for at least 3 months prior to screening
  • BMI= 27-45 kg/m2
  • HbA1c value between 7.5% and 11%

Exclusion Criteria:

  • Treated with oral anti-diabetic medications other than metformin and sulfonylurea within 3 months of screening
  • Patients treated previously with AC2993
  • Patients presently treated with insulin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035984

  Show 100 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00035984     History of Changes
Other Study ID Numbers: 2993-115
Study First Received: May 7, 2002
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Type 2 Diabetes Mellitis

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014