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Clinical Trial Details

Trial ID: L2195
Source ID: NCT00637273
Associated Drug: Exenatide Once Weekly
Title: A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00637273/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: exenatide once weekly|DRUG: sitagliptin|DRUG: pioglitazone|DRUG: placebo tablet|DRUG: placebo once weekly
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 26, Absolute change in HbA1c from baseline (Day 1) to Week 26 \[Week 26 - Baseline\]., Day 1, Week 26 | Secondary: Percentage of Subjects Achieving HbA1c Target of <7% at Week 26, Percentages of subjects achieving HbA1c target values of \<7% at Week 26., Week 26|Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26, Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 26., Week 26|Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26, Percentages of subjects achieving HbA1c target values of \<=6.0% at Week 26., Week 26|Change in Body Weight From Baseline to Week 26, Change in body weight from baseline (Day 1) to Week 26., Day 1, Week 26|Change in Fasting Plasma Glucose From Baseline to Week 26, Change in fasting plasma glucose from baseline (Day 1) to Week 26., Day 1, Week 26|Change in Systolic Blood Pressure From Baseline to Week 26, Change in systolic blood pressure from baseline (Day 1) to Week 26., Day 1, Week 26|Change in Diastolic Blood Pressure From Baseline to Week 26, Change in diastolic blood pressure from baseline (Day 1) to Week 26., Day 1, Week 26|Change in Fasting Total Cholesterol From Baseline to Week 26, Change in fasting total cholesterol from baseline (Day 1) to Week 26., Day 1, Week 26|Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26, Change in fasting HDL from baseline (Day 1) to Week 26., Day 1, Week 26|Ratio of Fasting Triglycerides at Week 26 to Baseline, Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline., Day 1, Week 26|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events, Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration \< 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration \< 54 mg/dL prior to treatment and not classified as major hypoglycemia., Day 1 to Week 26
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 514
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-01
Completion Date: 2009-07
Results First Posted: 2012-06-19
Last Update Posted: 2015-04-07
Locations: Research Site, Peoria, Arizona, United States|Research Site, Artesia, California, United States|Research Site, Concord, California, United States|Research Site, Encino, California, United States|Research Site, Greenbrae, California, United States|Research Site, La Mesa, California, United States|Research Site, Orange, California, United States|Research Site, Walnut Creek, California, United States|Research Site, Whittier, California, United States|Research Site, Colorado Springs, Colorado, United States|Research Site, Washington, District of Columbia, United States|Research Site, Coral Gables, Florida, United States|Research Site, Deland, Florida, United States|Research Site, Melbourne, Florida, United States|Research Site, Miami, Florida, United States|Research Site, New Port Richey, Florida, United States|Research Site, Decatur, Georgia, United States|Research Site, Avon, Indiana, United States|Research Site, Wichita, Kansas, United States|Research Site, Paducah, Kentucky, United States|Research Site, Baton Rouge, Louisiana, United States|Research Site, New Orleans, Louisiana, United States|Research Site, Oxon Hill, Maryland, United States|Research Site, Boston, Massachusetts, United States|Research Site, Chelsea, Michigan, United States|Research Site, Ypsilanti, Michigan, United States|Research Site, St. Louis Park, Minnesota, United States|Research Site, St. Louis, Missouri, United States|Research Site, Butte, Montana, United States|Research Site, Lincoln, Nebraska, United States|Research Site, Las Vegas, Nevada, United States|Research Site, New Hyde Park, New York, United States|Research Site, New Windsor, New York, United States|Research Site, New York, New York, United States|Research Site, Rochester, New York, United States|Research Site, Durham, North Carolina, United States|Research Site, Statesville, North Carolina, United States|Research Site, Winston-Salem, North Carolina, United States|Research Site, Athens, Ohio, United States|Research Site, Cincinnati, Ohio, United States|Research Site, Dayton, Ohio, United States|Research Site, Philadelphia, Pennsylvania, United States|Research Site, Rapid City, South Dakota, United States|Research Site, Memphis, Tennessee, United States|Research Site, Austin, Texas, United States|Research Site, Dallas, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Richmond, Virginia, United States|Research Site, Olympia, Washington, United States|Research Site, Spokane, Washington, United States|Research Site, Tacoma, Washington, United States|Research Site, Bangalore, India|Research Site, Indore, India|Research Site, Karnal, India|Research Site, Mumbai, India|Research Site, Pune, India|Research Site, Mexico City, Distrito Federal, Mexico|Research Site, Guadalajara, Jalisco, Mexico|Research Site, Zapopan, Jalisco, Mexico|Research Site, Cuernavaca, Morelos, Mexico|Research Site, Monterrey, NuevoLeon, Mexico|Research Site, Toluca, Mexico
URL: https://clinicaltrials.gov/show/NCT00637273