WelChol® and Insulin in Treating Patients With Type 2 Diabetes
NCT ID: NCT00151749
Last Updated: 2012-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
260 participants
INTERVENTIONAL
2004-06-30
2005-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Colesevelam hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes
* Stable insulin therapy for 6 weeks
* Stable dose of any other antidiabetic medications for 90 days
* Hemoglobin A1c value between 7.5% to 9.5%
* C peptide greater than 0.5 ng/mL
* Prescribed ADA diet
Exclusion Criteria
* History of pancreatitis
* Uncontrolled hypertension
* Allergy or toxic response to colesevelam or any of its components
* Serum LDL-C less than 60 mg/dL
* Serum TG greater than 500 mg/dL
* Body mass index (BMI) greater than 45 kg/m2-
18 Years
75 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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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 D.C., 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 City, , Mexico
Lima, , Peru
Countries
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References
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Goldberg RB, Fonseca VA, Truitt KE, Jones MR. Efficacy and safety of colesevelam in patients with type 2 diabetes mellitus and inadequate glycemic control receiving insulin-based therapy. Arch Intern Med. 2008 Jul 28;168(14):1531-40. doi: 10.1001/archinte.168.14.1531.
Other Identifiers
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WEL-302
Identifier Type: -
Identifier Source: org_study_id
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