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Clinical Trial Details

Trial ID: L2430
Source ID: NCT01376557
Associated Drug: 75 Mg Lx4211
Title: Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01376557/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: 75 mg LX4211|DRUG: 200 mg LX4211|DRUG: 400 mg LX4211|DRUG: 200 mg LX4211|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in HbA1c to Week 12, 12 weeks | Secondary: Number of Participants Achieving a HbA1c Value of <7% at Week 12, 12 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12, 12 weeks|Change From Baseline in Body Weight at Week 12, 12 weeks|Change From Baseline in Systolic Blood Pressure (SPB) at Week 12, 12 weeks|Change From Baseline in Triglycerides at Week 12, 12 weeks
Sponsor/Collaborators: Sponsor: Lexicon Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 299
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-06
Completion Date: 2012-05
Results First Posted: 2014-10-31
Last Update Posted: 2014-10-31
Locations: Lexicon Investigational Site, Anaheim, California, 92801, United States|Lexicon Investigational Site, Carmichael, California, 95608, United States|Lexicon Investigational Site, Greenbrae, California, 94904, United States|Lexicon Investigational Site, La Jolla, California, 92037, United States|Lexicon Investigational Site, Northridge, California, 91325, United States|Lexicon Investigational Site, Orange, California, 92868, United States|Lexicon Investigational Site, Pismo Beach, California, 93449, United States|Lexicon Investigational Site, Tarzana, California, 91356, United States|Lexicon Investigational Site, Tustin, California, 92780, United States|Lexicon Investigational Site, Denver, Colorado, 80209, United States|Lexicon Investigational Site, Denver, Colorado, 80220, United States|Lexicon Investigational Site, Newark, Delaware, 19713, United States|Lexicon Investigational Site, Edgewater, Florida, 32132, United States|Lexicon Investigational Site, Miami, Florida, 33135, United States|Lexicon Investigational Site, Orlando, Florida, 32806, United States|Lexicon Investigational Site, West Palm Beach, Florida, 33401, United States|Lexicon Investigational Site, Winter Park, Florida, 32792, United States|Lexicon Investigational Site, Blue Ridge, Georgia, 30513, United States|Lexicon Investigational Site, Savannah, Georgia, 31406, United States|Lexicon Investigational Site, Lafayette, Indiana, 47904, United States|Lexicon Investigational Site, Madisonville, Kentucky, 42431, United States|Lexicon Investigational Site, Baton Rouge, Louisiana, 70808, United States|Lexicon Investigational Site, Brockton, Massachusetts, 02301, United States|Lexicon Investigational Site, Waltham, Massachusetts, 02453, United States|Lexicon Investigational Site, Traverse City, Michigan, 49684, United States|Lexicon Investigational Site, Olive Branch, Mississippi, 38654, United States|Lexicon Investigational Site, Kansas City, Missouri, 64111, United States|Lexicon Investigational Site, Omaha, Nebraska, 68131, United States|Lexicon Investigational Site, Las Vegas, Nevada, 89101, United States|Lexicon Investigational Site, Las Vegas, Nevada, 89128, United States|Lexicon Investigational Site, Great Neck, New York, 11023, United States|Lexicon Investigational Site, West Seneca, New York, 14224, United States|Lexicon Investigational Site, Greensboro, North Carolina, 27455, United States|Lexicon Investigational Site, Winston-Salem, North Carolina, 27103, United States|Lexicon Investigational Site, Grand Forks, North Dakota, 58201, United States|Lexicon Investigational Site, Canal Fulton, Ohio, 44614, United States|Lexicon Investigational Site, Dayton, Ohio, 45439, United States|Lexicon Investigational Site, Kettering, Ohio, 45429, United States|Lexicon Investigational Site, Perrysburg, Ohio, 43551, United States|Lexicon Investigational Site, Eugene, Oregon, 97404, United States|Lexicon Investigational Site, Uniontown, Pennsylvania, 15401, United States|Lexicon Investigational Site, Clinton, South Carolina, 29325, United States|Lexicon Investigational Site, Mt. Pleasant, South Carolina, 29464, United States|Lexicon Investigational Site, Chattanooga, Tennessee, 37411, United States|Lexicon Investigational Site, Chattanooga, Tennessee, 37421, United States|Lexicon Investigational Site, Austin, Texas, 78728, United States|Lexicon Investigational Site, Dallas, Texas, 75230, United States|Lexicon Investigational Site, Houston, Texas, 77024, United States|Lexicon Investigational Site, Houston, Texas, 77098, United States|Lexicon Investigational Site, Killeen, Texas, 76543, United States|Lexicon Investigational Site, San Antonio, Texas, 78229, United States|Lexicon Investigational Site, San Antonio, Texas, 78258, United States|Lexicon Investigational Site, Tomball, Texas, 77375, United States|Lexicon Investigational Site, Ogden, Utah, 84403, United States|Lexicon Investigational Site, Salt Lake City, Utah, 84109, United States|Lexicon Investigational Site, Virginia Beach, Virginia, 23454, United States
URL: https://clinicaltrials.gov/show/NCT01376557