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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00039013
First received: June 6, 2002
Last updated: February 23, 2015
Last verified: January 2015
June 6, 2002
February 23, 2015
March 2002
June 2003   (Final data collection date for primary outcome measure)
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).
Not Provided
Complete list of historical versions of study NCT00039013 on ClinicalTrials.gov Archive Site
  • 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
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Not Provided
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Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • 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
  • 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
  • Experimental: AC2993 5 mcg (0.02 mL)
    Placebo, then AC2993 5 mcg, then AC2993 5 mcg
    Intervention: Drug: AC2993
  • Experimental: AC2993 10mcg (0.04 mL)
    Placebo, then AC2993 5 mcg, then AC2993 10 mcg
    Intervention: Drug: AC2993
  • Placebo Comparator: Placebo 0.02 mL
    Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo 0.04 mL
    Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
June 2003
June 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00039013
2993-112
No
Not Provided
Not Provided
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AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
January 2015

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