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Completed

NCT Number: NCT00381342

Safety and Efficacy of Exenatide as Monotherapy

This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Aligarh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with type 2 diabetes
  • Treating diabetes with diet and exercise
  • HbA1c between 6.5% and 10.0%, inclusive
  • Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive

Exclusion criteria

  • Have previously completed or withdrawn from this study
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
  • Have been treated with any antidiabetic agent
  • Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening
  • Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study

Treatment and study plan

exenatide

Drug

Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day

Other names: Byetta

Placebo

Drug

subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day

Primary outcomes

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24

    Time frame: Baseline, Week 24

    Change in HbA1c from Baseline to Week 24

Secondary outcomes

  1. Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less

    Time frame: Baseline, Weeks 4, 8, 12, 16, 24

    Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less

  2. Change in fasting serum glucose (FSG) from Baseline to Week 24

    Time frame: Baseline, Weeks 4, 8, 12, 16, and 24

    Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between

  3. Change in body weight from Baseline to Week 24

    Time frame: Baseline, Weeks 4, 8, 12, 16, and 24

    Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between

  4. Change in glucose measurements from Baseline to Week 24

    Time frame: Baseline, Weeks 4, 8, 12, 16, 24

    Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between

  5. Changes in beta-cell function and insulin sensitivity from Baseline to Week 24

    Time frame: Baseline, Weeks 4, 8, 12, 16, and 24

    Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between

  6. Changes in fasting and 30, 60, 120 and 180-minute glucose measurements

    Time frame: Immediately before glucose load, then 30, 60, 120, and 180 minutes post

    Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 27, 2006
Registry last updated
Feb 23, 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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