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Clinical Trial Details

Trial ID: L4577
Source ID: NCT00147719
Associated Drug: Colesevelam Hydrochloride
Title: WelChol® With Metformin in Treating Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Colesevelam hydrochloride
Outcome Measures: Primary: To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy | Secondary: To assess the fasting plasma glucose and fructosamine lowering effect;|To assess the glycemic control response rate;|To assess the improvement in insulin sensitivity;|To assess the effect on high sensitivity C-reactive protein;|To assess the improvement in lipids, and lipoproteins;|To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy
Sponsor/Collaborators: Sponsor: Daiichi Sankyo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2004-06
Completion Date: 2006-07
Results First Posted:
Last Update Posted: 2012-01-18
Locations: CRO, Jonesboro, Arkansas, United States|Beverly Hills, California, United States|Carmichael, California, United States|Fresno, California, United States|Irvine, California, United States|La Jolla, California, United States|Los Gatos, California, United States|San Diego, California, United States|Spring Valley, California, United States|West Hills, California, United States|Washington, District of Columbia, United States|Coco Beach, Florida, United States|Largo, Florida, United States|Miami, Florida, United States|Pembroke Pines, Florida, United States|West Palm Beach, Florida, United States|Atlanta, Georgia, United States|Evansville, Indiana, United States|Louisville, Kentucky, United States|Detroit, Michigan, United States|Troy, Michigan, United States|Edina, Minnesota, United States|Chesterfield, Missouri, United States|Bozeman, Montana, United States|Butte, Montana, United States|Las Vegas, Nevada, United States|Rochester, New York, United States|Charlotte, North Carolina, United States|Winston-Salem, North Carolina, United States|Cincinnati, Ohio, United States|Cleveland, Ohio, United States|Lyndhurst, Ohio, United States|Marion, Ohio, United States|Oklahoma City, Oklahoma, United States|Tulsa, Oklahoma, United States|Portland, Oregon, United States|Beaver, Pennsylvania, United States|Charleston, South Carolina, United States|Columbia, South Carolina, United States|Morristown, Tennessee, United States|Corpus Christi, Texas, United States|Dallas, Texas, United States|Pharr, Texas, United States|San Antonio, Texas, United States|Arlington, Virginia, United States|Richmond, Virginia, United States|Mexico DF, Mexico|Lima, Peru
URL: https://clinicaltrials.gov/show/NCT00147719

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress