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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035984
First Posted: May 8, 2002
Last Update Posted: February 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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
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 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 AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c from Baseline to Week 30 [ Time Frame: Baseline (Day 1) to Week 30 ]
    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 ]
    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


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00035984


  Show 100 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00035984     History of Changes
Other Study ID Numbers: 2993-115
First Submitted: May 7, 2002
First Posted: May 8, 2002
Last Update Posted: February 24, 2015
Last Verified: January 2015

Keywords provided by AstraZeneca:
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists