WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes
NCT ID: NCT00147758
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
400 participants
INTERVENTIONAL
2004-06-30
2006-08-31
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 dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days
* Hemoglobin A1c value 7.5% to 9.5%, inclusive
* C peptide \> 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 \< 60 mg/dL
* Serum TG \> 500 mg/dL
* Body mass index (BMI) \> 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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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 City, , Mexico
Lima, , Peru
Countries
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References
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Fonseca VA, Rosenstock J, Wang AC, Truitt KE, Jones MR. Colesevelam HCl improves glycemic control and reduces LDL cholesterol in patients with inadequately controlled type 2 diabetes on sulfonylurea-based therapy. Diabetes Care. 2008 Aug;31(8):1479-84. doi: 10.2337/dc08-0283. Epub 2008 May 5.
Other Identifiers
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WEL-303
Identifier Type: -
Identifier Source: org_study_id
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