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Safety and Efficacy of Exenatide as Monotherapy

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00381342
First received: September 25, 2006
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

September 25, 2006
February 5, 2013
September 2006
September 2007   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Change in HbA1c from Baseline to Week 24
To test the hypothesis that glycemic control with exenatide twice-daily is superior to placebo twice-daily in patients with type 2 diabetes experiencing inadequate glycemic control through diet and exercise.
Complete list of historical versions of study NCT00381342 on ClinicalTrials.gov Archive Site
  • Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 24 ] [ Designated as safety issue: No ]
    Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less
  • Change in fasting serum glucose (FSG) from Baseline to Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, and 24 ] [ Designated as safety issue: No ]
    Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between
  • Change in body weight from Baseline to Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, and 24 ] [ Designated as safety issue: No ]
    Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between
  • Change in glucose measurements from Baseline to Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 24 ] [ Designated as safety issue: No ]
    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
  • Changes in beta-cell function and insulin sensitivity from Baseline to Week 24 [ Time Frame: Baseline, Weeks 4, 8, 12, 16, and 24 ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: No ]
    Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin
To compare exenatide to placebo with regard to the following: various pharmacodynamic measurements, change in body weight, safety and tolerability, incidence of hypoglycemic events, and change in beta-cell function and insulin sensitivity.
Not Provided
Not Provided
 
Safety and Efficacy of Exenatide as Monotherapy
Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide
    Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
    Other Name: Byetta
  • Drug: exenatide
    Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day
    Other Name: Byetta
  • Drug: placebo
    subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day
  • Experimental: Exenatide 5 mcg/exenatide 5 mcg
    Exenatide 5 mcg; then exenatide 5 mcg
    Intervention: Drug: exenatide
  • Experimental: Exenatide 5 mcg/exenatide 10 mcg
    Exenatide 5 mcg, then exenatide 10 mcg
    Intervention: Drug: exenatide
  • Placebo Comparator: Placebo
    Placebo in volumes equivalent to exenatide
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
233
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Puerto Rico,   Romania,   Russian Federation
 
NCT00381342
H8O-MC-GWBJ
No
Amylin Pharmaceuticals, LLC.
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
Amylin Pharmaceuticals, LLC.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP