Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)
Tracking Information
Start Date ICMJE | November 2008 |
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Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 9, 2008) | Test hypothesis that exenatide once weekly is superior to metformin, sitagliptin, and pioglitazone in HbA1c reduction at 26 weeks compared to baseline, in drug-naive patients with type 2 diabetes who are inadequately treated with diet and exercise. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00676338 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 9, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4) |
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Official Title ICMJE | Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes |
Brief Summary | This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Type 2 Diabetes Mellitus |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 822 | ||||
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Estimated Completion Date | September 2010 | ||||
Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Belgium, Brazil, Canada, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, South Africa, Spain, Turkey, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00676338 | ||||
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Responsible Party | Study Director, Eli Lilly and Company | ||||
Study ID Numbers ICMJE | H8O-MC-GWCH (DURATION - 4) | ||||
Study Sponsor ICMJE | Amylin Pharmaceuticals, Inc. | ||||
Collaborators ICMJE | Eli Lilly and Company | ||||
Investigators ICMJE |
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Information Provided By | Amylin Pharmaceuticals, Inc. |
Source: http://clinicaltrials.gov/