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Clinical Trial Details

Trial ID: L4529
Source ID: NCT00151749
Associated Drug: Colesevelam Hydrochloride
Title: WelChol® and Insulin 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 WelChol® to current antidiabetic therapy | Secondary: To assess: the effects on fasting plasma glucose and|fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add-|on therapy to patients receiving insulin alone or with|other oral drugs
Sponsor/Collaborators: Sponsor: Daiichi Sankyo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 260
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2004-06
Completion Date: 2005-12
Results First Posted:
Last Update Posted: 2012-01-18
Locations: Tuscumbia, Alabama, United States|Sierra Vista, Arizona, United States|Jonesboro, Arkansas, United States|Searcy, Arkansas, United States|Carmichael, California, United States|Concord, California, United States|Fullerton, California, United States|La Jolla, California, United States|San Diego, California, United States|West Hills, California, United States|Washington, District of Columbia, United States|Largo, Florida, United States|Miami, Florida, United States|New Port Richey, Florida, United States|West Palm Beach, Florida, United States|Chicago, Illinois, United States|Indianapolis, Indiana, United States|Lexington, Kentucky, United States|Louisville, Kentucky, United States|New Orleans, Louisiana, United States|Boston, Massachusetts, United States|Troy, Michigan, United States|Edina, Minnesota, United States|Chesterfield, Missouri, United States|Kansas City, Missouri, United States|St. Louis, Missouri, United States|Bozeman, Montana, United States|Butte, Montana, United States|Englewood, New Jersey, United States|Charlotte, North Carolina, United States|Hickory, North Carolina, United States|Raleigh, North Carolina, United States|Statesville, North Carolina, United States|Winston-Salem, North Carolina, United States|Cincinnati, Ohio, United States|Marion, Ohio, United States|Portland, Oregon, United States|Beaver, Pennsylvania, United States|Charleston, South Carolina, United States|Bristol, Tennessee, United States|Morristown, Tennessee, United States|Dallas, Texas, United States|Houston, Texas, United States|Midland, Texas, United States|San Antonio, Texas, United States|Mexico DF, Mexico|Lima, Peru
URL: https://clinicaltrials.gov/show/NCT00151749