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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: Placebo 0.01 mL
Drug: Placebo 0.02 mL
Drug: Placebo 0.03 mL
Drug: Placebo 0.04 mL
Drug: AC2993 2.5 mcg
Drug: AC2993 5.0 mcg
Drug: AC2993 7.5 mcg
Drug: AC2993 10.0 mcg
Phase 2

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 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 156
Study Start Date: August 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 0.01 mL
2 week placebo lead-in followed by Placebo 0.01 mL
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
Placebo Comparator: Placebo 0.02 mL
2 week placebo lead-in followed by Placebo 0.02 mL
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
Placebo Comparator: Placebo 0.03 mL
2 week placebo lead-in followed by Placebo 0.03 mL
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
Placebo Comparator: Placebo 0.04 mL
2 week placebo lead-in followed by Placebo 0.04 mL
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
Experimental: AC2993 2.5 mcg
2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL
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
Experimental: AC2993 5.0 mcg
2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL
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
Experimental: AC2993 7.5 mcg
2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL
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
Experimental: AC2993 10.0 mcg
2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044694

  Show 33 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: NCT00044694     History of Changes
Other Study ID Numbers: 2993-116
Study First Received: September 3, 2002
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Diabetes Mellitus, Type 2

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 23, 2014