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Safety and Efficacy of Exenatide as Monotherapy

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.
 
ClinicalTrials.gov Identifier: NCT00381342
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : February 23, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 25, 2006
First Posted Date  ICMJE September 27, 2006
Last Update Posted Date February 23, 2015
Study Start Date  ICMJE September 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24 [ Time Frame: Baseline, Week 24 ]
Change in HbA1c from Baseline to Week 24
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2006)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2006)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Exenatide as Monotherapy
Official Title  ICMJE Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2008)
233
Original Enrollment  ICMJE
 (submitted: September 25, 2006)
258
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   Puerto Rico,   Romania,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00381342
Other Study ID Numbers  ICMJE H8O-MC-GWBJ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director: James Malone, MD Eli Lilly and Company
PRS Account AstraZeneca
Verification Date January 2015

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