WelChol® With Metformin in Treating Patients With Type 2 Diabetes
NCT ID: NCT00147719
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
300 participants
INTERVENTIONAL
2004-06-30
2006-07-31
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
* Hemoglobin (HbA1c) between 7.5% to 9.5%
* Prescribed an ADA accepted diet
* Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1
Exclusion Criteria
* History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
* History of pancreatitis
* Uncontrolled hypertension
* Recent severe cardiovascular disease
* Allergy or toxic response to colesevelam or any of its components
* 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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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 D.C., 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 City, , Mexico
Lima, , Peru
Countries
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References
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Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975.
Other Identifiers
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WEL-301
Identifier Type: -
Identifier Source: org_study_id
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