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Completed

NCT Number: NCT00039026

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

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 (sulfonylurea) throughout the study.

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Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pinnacle Research Group, Anniston, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with Type 2 diabetes mellitus
  • Treated with 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 a sulfonylurea within 3 months of screening
  • Patients treated previously with AC2993
  • Patients presently treated with insulin

Treatment and study plan

AC2993

Drug

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 names: synthetic exendin-4

Placebo

Drug

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

Primary outcomes

  1. 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 outcomes

  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 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

  5. 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%

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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 a Sulfonylurea Alone

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Jun 10, 2002
Registry last updated
Feb 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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