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Completed

NCT Number: NCT00044694

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

This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this 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

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Healthsouth Clinical Research, Birmingham, 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
  • Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
  • BMI 27-45 kg/m^2
  • HbA1c between 7.0 % and 8.0 %

Exclusion criteria

  • Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
  • Patients previously treated with AC2993
  • Patients presently treated with insulin

Treatment and study plan

Placebo 0.01 mL

Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily

Placebo 0.02 mL

Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily

Placebo 0.03 mL

Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily

Placebo 0.04 mL

Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily

AC2993 2.5 mcg

Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily

Other names: synthetic exendin-4

AC2993 5.0 mcg

Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily

Other names: synthetic exendin-4

AC2993 7.5 mcg

Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily

Other names: synthetic exendin-4

AC2993 10.0 mcg

Drug

2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily

Other names: synthetic exendin-4

Primary outcomes

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28

    Time frame: Baseline (Day 1) to Day 28

    Change in HbA1c from Baseline (Day 1) to study termination (Day 28)

Secondary outcomes

  1. Change in HbA1c from Baseline to Day 14

    Time frame: Baseline, Day 14

    Change in HbA1c from Baseline (Day 1) to Day 14

  2. Change in fasting plasma glucose from Baseline to Day 14 and to Day 28

    Time frame: Baseline, Day 14, Day28

    Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)

  3. Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28

    Time frame: Baseline, Day 14, Day 28

    Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Sep 5, 2002
Registry last updated
Feb 20, 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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