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

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ClinicalTrials.gov Identifier: NCT00039013
Recruitment Status : Completed
First Posted : June 10, 2002
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: AC2993 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Two Times a Day in Subjects With Type 2 Diabetes Mellitus Treated With Metformin Alone
Study Start Date : March 2002
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
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Arm Intervention/treatment
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 / Placebo (0.02 mL) for 4 weeks / Placebo (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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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%

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039013


Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00039013    
Other Study ID Numbers: 2993-112
First Posted: June 10, 2002    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists