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Clinical Trial Details

Trial ID: L4107
Source ID: NCT00147758
Associated Drug: Colesevelam Hydrochloride
Title: WelChol® and Sulfonylurea 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 efficacy;|To assess glycemic control response rate;|To assess the improvement in insulin sensitivity;|To assess the effect on C reactive protein;|To assess lipids and lipoproteins;|To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy
Sponsor/Collaborators: Sponsor: Daiichi Sankyo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 400
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2004-06
Completion Date: 2006-08
Results First Posted:
Last Update Posted: 2012-01-18
Locations: Birmingham, Alabama, United States|Tuscumbia, Alabama, United States|Little Rock, Arkansas, United States|Searcy, Arkansas, United States|Concord, California, United States|Irvine, California, United States|La Jolla, California, United States|Los Angeles, California, United States|Los Gatos, California, United States|West Hills, California, United States|Coral Gables, Florida, United States|Miami, Florida, United States|New Port Richey, Florida, United States|Pembroke Pines, Florida, United States|West Palm Beach, Florida, United States|Atlanta, Georgia, United States|Chicago, Illinois, United States|Indianapolis, Indiana, United States|New Orleans, Louisiana, United States|Boston, Massachusetts, United States|Kansas City, Missouri, United States|St. Louis, Missouri, United States|Rochester, New York, United States|Charlotte, North Carolina, United States|Hickory, North Carolina, United States|Statesville, North Carolina, United States|Winston-Salem, North Carolina, United States|Cincinnati, Ohio, United States|Cleveland, Ohio, United States|Marion, Ohio, United States|Perrysburg, 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|Bristol, Tennessee, United States|Dallas, Texas, United States|Houston, Texas, United States|Midland, Texas, United States|San Antonio, Texas, United States|Arlington, Virginia, United States|Richmond, Virginia, United States|Lakewood, Washington, United States|Renton, Washington, United States|Mexico DF, Mexico|Lima, Peru
URL: https://clinicaltrials.gov/show/NCT00147758