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Clinical Trial Details

Trial ID: L5435
Source ID: NCT00519142
Associated Drug: Placebo For Mitiglinide
Title: Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: placebo for mitiglinide|DRUG: mitiglinide|DRUG: mitiglinide
Outcome Measures: Primary: change from baseline in HbA1c, after 24 weeks of treatment | Secondary: change from baseline in 2-hour post-prandial glucose, after 24 weeks of treatment|change from baseline in fasting plasma glucose, after 24 weeks of treatment
Sponsor/Collaborators: Sponsor: Elixir Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 367
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2007-08
Completion Date: 2008-10
Results First Posted:
Last Update Posted: 2009-09-17
Locations: Elixir Study Site, Glendale, Arizona, United States|Elixir Study Site, Greenbrae, California, United States|Elixir Study Site, La Jolla, California, United States|Elixir Study Site, Los Angeles, California, United States|Elixir Study Site, Los Gatos, California, United States|Elixir Study Site(s), Oakland Area, California, United States|Elixir Study Site, Orange, California, United States|Elixir Study Site, West Hills, California, 91307, United States|Elixir Study Site, Westlake Village, California, United States|Elixir Study Site, Pueblo, Colorado, United States|Elixir Study Site(s), Washington, District of Columbia, United States|Elixir Study Site, Chiefland, Florida, 32626, United States|Elixir Study Site, Coral Gables, Florida, United States|Elixir Study Site, Kissimmee, Florida, United States|Elixir Study Site(s), Miami, Florida, United States|Elixir Study Site, St. Cloud, Florida, United States|Elixir Study Site, Winter Park, Florida, United States|Elixir Study Site, Atlanta, Georgia, 30080, United States|Elixir Study Site, Austell, Georgia, United States|Elixir Study Site, Perry, Georgia, United States|Elixir Study Site(s), Chicago, Illinois, United States|Elixir Study Site, Wichita, Kansas, United States|Elixir Study Site, Kansas City, Missouri, 64132, United States|Elixir Study Site, St Louis, Missouri, 63110, United States|Elixir Study Site, Las Vegas, Nevada, United States|Elixir Study Site, Hamilton, New Jersey, United States|Elixir Study Site, Hillsborough, New Jersey, United States|Elixir Study Site, Sewell, New Jersey, United States|Elixir Study Site(s), New York, New York, United States|Elixir Study Site, Mooresville, North Carolina, United States|Elixir Study Site, Morehead City, North Carolina, United States|Elixir Study Site, Akron, Ohio, United States|Elixir Study Site, Cincinnati, Ohio, United States|Elixir Study Site, Gallipolis, Ohio, United States|Elixir Study Site, Kettering, Ohio, United States|Elixir Study Site, Medford, Oregon, United States|Elixir Study Site, Harleysville, Pennsylvania, United States|Elixir Study Site, Levittown, Pennsylvania, United States|Elixir Study Site, Uniontown, Pennsylvania, United States|Elixir Study Site, Columbia, South Carolina, United States|Elixir Study Site, Simpsonville, South Carolina, United States|Elixir Study Site, Memphis, Tennessee, United States|Elixir Study Site, Tullahoma, Tennessee, United States|Elixir Study Site(s), Dallas, Texas, United States|Elixir Study Site, El Paso, Texas, United States|Elixir Study Site(s), Fort Worth, Texas, United States|Elixir Study Site(s), Houston, Texas, United States|Elixir Study Site, Humble, Texas, United States|Elixir Study Site, Midland, Texas, United States|Elixir Study Site, N. Richland Hills, Texas, United States|Elixir Study Site, New Braunfels, Texas, United States|Elixir Study Site, Pearland, Texas, United States|Elixir Study Site, Plano, Texas, 75074, United States|Elixir Study Site(s), San Antonio, Texas, United States|Elixir Study Site, Temple, Texas, United States|Elixir Study Site, Norfolk, Virginia, United States|Elixir Study Site, Federal Way, Washington, United States|Elixir Study Site, Carolina, 00983, Puerto Rico|Elixir Study Site, Fajardo, 00738, Puerto Rico|Elixir Study Site(s), Ponce, Puerto Rico|Elixir Study Site(s), San Juan, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00519142

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress