Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

Overview

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 medication (metformin) throughout the study.

Full Title of Study: “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 Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With Metformin Alone”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2003

Interventions

  • 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
  • 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
  • Drug: Placebo
    • Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks – All are subcutaneously injected twice daily
  • 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

Arms, Groups and Cohorts

  • Experimental: AC2993 5 mcg (0.02 mL)
    • Placebo, then AC2993 5 mcg, then AC2993 5 mcg
  • Experimental: AC2993 10mcg (0.04 mL)
    • Placebo, then AC2993 5 mcg, then AC2993 10 mcg
  • Placebo Comparator: Placebo 0.02 mL
    • Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL
  • Placebo Comparator: Placebo 0.04 mL
    • Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL

Clinical Trial Outcome Measures

Primary Measures

  • Change in HbA1c (glycosylated hemoglobin) from baseline to study termination (Week 30)
    • Time Frame: Baseline (Day 1), Week 30
    • Change in HbA1c from from baseline, measured from Visit 3 (Day 1) to study termination (Week 30).

Secondary 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • Change in body weight (kg) from Baseline to each intermediate visit and Week 30

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects with Type 2 diabetes mellitus – Treated with metformin within a defined dose range 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 within 3 months of screening – Patients treated previously with AC2993 – Patients presently treated with insulin

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

DeFronzo RA, Ratner RE, Han J, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005 May;28(5):1092-100. doi: 10.2337/diacare.28.5.1092.

Ratner RE, Maggs D, Nielsen LL, Stonehouse AH, Poon T, Zhang B, Bicsak TA, Brodows RG, Kim DD. Long-term effects of exenatide therapy over 82 weeks on glycaemic control and weight in over-weight metformin-treated patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2006 Jul;8(4):419-28. doi: 10.1111/j.1463-1326.2006.00589.x.

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