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Clinical Trial Details

Trial ID: L5752
Source ID: NCT00789737
Associated Drug: Welchol
Title: Welchol as Monotherapy for Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00789737/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Welchol|DRUG: Placebo
Outcome Measures: Primary: Percent Change in Hemoglobin A1c, change in HbA1c from baseline to Week 24, 24 week | Secondary: Change in Fasting Plasma Glucose, to determine changes in Glycemic control after 24 weeks on therapy, from baseline to 24 weeks|% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units, to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline., 24 weeks|% Subjects Achieving an HbA1C Goal of <7.0, % Subjects achieving an HbA1C goal of \<7.0 at 24 weeks, 24 weeks|% Subjects With a Decrease in FPG >=30 mg/dL, % Subjects with a decrease in Fasting Plasma Glucose \>=30 mg/dL from baseline to 24 weeks, from baseline to 24 weeks|Changes in Total Cholesterol [TC], To assess the effects of Welchol on changes in total cholesterol \[TC\], from baseline to 24 weeks|Changes in Low Density Lipoprotein Cholesterol [LDL-C], To assess the effects of Welchol on changes in low density lipoprotein cholesterol \[LDL-C\], from baseline to 24 weeks|Changes in High Density Lipoprotein Cholesterol [HDL-C], To assess the effects of Welchol on changes in high density lipoprotein cholesterol \[HDL-C\], from baseline to 24 weeks|Changes in Non-HDL-C, To assess the effects of Welchol on changes in non-HDL-C, from baseline to 24 weeks|Changes in Triglycerides [TG], To assess the effects of Welchol on changes in triglycerides \[TG\], from baseline to 24 weeks|Changes in Apolipoprotein A-I (apoA-I), To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I), from baseline to 24 weeks|Changes in Apolipoprotein B (apoB), To assess the effects of Welchol on changes in apolipoprotein B (apoB), from baseline to 24 weeks|Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test, To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test, from baseline to 24 weeks
Sponsor/Collaborators: Sponsor: Daiichi Sankyo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 357
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-01
Completion Date: 2011-12
Results First Posted: 2014-01-22
Last Update Posted: 2014-02-27
Locations: Birmingham, Alabama, 35216, United States|Birmingham, Alabama, 35294, United States|Montgomery, Alabama, 36117, United States|Muscle Shoals, Alabama, 35662, United States|Green Valley, Arizona, 85614, United States|Mesa, Arizona, 85203, United States|Mesa, Arizona, 85210, United States|Tucson, Arizona, 85705, United States|Tucson, Arizona, 85723, United States|Tucson, Arizona, 85741, United States|Searcy, Arkansas, 72143, United States|Buena Park, California, 90620, United States|Burbank, California, 91505, United States|Chula Vista, California, 91910, United States|Garden Grove, California, 92844, United States|Huntington Park, California, 90255, United States|Irvine, California, 92618, United States|La Mirada, California, 90638, United States|Lincoln, California, 95648, United States|Lomita, California, 90717, United States|Los Angeles, California, 90015, United States|Los Angeles, California, 90057, United States|Los Gatos, California, 95032, United States|Santa Ana, California, 92701, United States|Tustin, California, 92780, United States|Walnut creek, California, 94598, United States|Brooksville, Florida, 34601, United States|Coral Gables, Florida, 33134, United States|DeLand, Florida, 32720, United States|Delray Beach, Florida, 33484, United States|Gulf Breeze, Florida, 32561, United States|Hialeah, Florida, 33012, United States|Jacksonville, Florida, 32223, United States|Kissimmee, Florida, 34741, United States|Miami, Florida, 33135, United States|Miami, Florida, 33169, United States|Miami, Florida, 33175, United States|New Port Richey, Florida, 34652, United States|Ocala, Florida, 34471, United States|Ormond Beach, Florida, 32174, United States|Pembroke Pines, Florida, 33026, United States|Vero Beach, Florida, 32960, United States|Wellington, Florida, 33449, United States|Winter Park, Florida, 32789, United States|Decatur, Georgia, 30035, United States|East Point, Georgia, 30344, United States|Roswell, Georgia, 30076, United States|Stockbridge, Georgia, 30281, United States|Stone Mountain, Georgia, 30083, United States|Nampa, Idaho, 83686, United States|Chicago, Illinois, 60607, United States|Evansville, Indiana, 47714, United States|LaPorte, Indiana, 46350, United States|South Bend, Indiana, 46614, United States|Crestview Hills, Kentucky, 41017, United States|Lafayette, Louisiana, 70503, United States|Prince Frederick, Maryland, 20678, United States|Silver Spring, Maryland, 20910, United States|New Bedford, Massachusetts, 02740, United States|Southfield, Michigan, 48034, United States|Port Gibson, Mississippi, 39150, United States|St. Louis, Missouri, 63128, United States|St. Louis, Missouri, 63141, United States|Billings, Montana, 59101, United States|Las Vegas, Nevada, 89123, United States|Berlin, New Jersey, 08009, United States|Clifton, New Jersey, 07013, United States|Mine Hill, New Jersey, 07803, United States|New Windsor, New York, 12553, United States|North Massapequa, New York, 11758-1802, United States|West Seneca, New York, 14224, United States|Lexington, North Carolina, 27295, United States|Statesville, North Carolina, 28625, United States|Wilmington, North Carolina, 28401, United States|Cincinnati, Ohio, 45219, United States|Cincinnati, Ohio, 45227, United States|Cincinnati, Ohio, 45245, United States|Cleveland, Ohio, 44122, United States|Cuyahoga Falls, Ohio, 44223, United States|Marion, Ohio, 43302, United States|Munroe Falls, Ohio, 44262, United States|Shaker Heights, Ohio, 44120, United States|Oklahoma City, Oklahoma, 73103, United States|Oklahoma City, Oklahoma, 73159, United States|Portland, Oregon, 97220, United States|Harrisburg, Pennsylvania, 17112, United States|Jersey Shore, Pennsylvania, 17740, United States|Charleston, South Carolina, 29412, United States|Charleston, South Carolina, 29414, United States|Columbia, South Carolina, 29201, United States|Greer, South Carolina, 29651, United States|Arlington, Texas, 76012, United States|Dallas, Texas, 75230, United States|Dallas, Texas, 75235, United States|Fort Worth, Texas, 76117, United States|Houston, Texas, 77008, United States|Houston, Texas, 77074, United States|Houston, Texas, 77081, United States|Houston, Texas, 77083, United States|San Antonio, Texas, 78229, United States|Sugar Land, Texas, 77479, United States|Tomball, Texas, 77375, United States|Salt Lake City, Utah, 84102, United States|Salt Lake City, Utah, 84107, United States|Manassas, Virginia, 20110, United States|Salem, Virginia, 24153, United States|Milwaukee, Wisconsin, 53209, United States
URL: https://clinicaltrials.gov/show/NCT00789737

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress