Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes
A Multi-Center, 52-Week, Open-Label Extension Study (From Studies WEL-301, WEL-302, and WEL-303) to Evaluate the Long-Term Safety and Tolerability of WelChol® in Type 2 Diabetic Patients
1 other identifier
interventional
780
3 countries
64
Brief Summary
This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Dec 2004
Typical duration for phase_3 type-2-diabetes
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJanuary 9, 2008
December 1, 2007
2.6 years
September 7, 2005
December 26, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy
Secondary Outcomes (3)
To assess the long-term effect on hemoglobin A1c
To assess the long-term effect on fasting plasma glucose
To assess effects on lipids and lipoproteins
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (64)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tuscumbia, Alabama, United States
Unknown Facility
Jonesboro, Arkansas, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Searcy, Arkansas, United States
Unknown Facility
Carmichael, California, United States
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Concord, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Gatos, California, United States
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San Diego, California, United States
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Spring Valley, California, United States
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West Hills, California, United States
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Washington D.C., District of Columbia, United States
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Cocoa Beach, Florida, United States
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Coral Gables, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Pembroke Pines, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Troy, Michigan, United States
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Edina, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Bozeman, Montana, United States
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Butte, Montana, United States
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Las Vegas, Nevada, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Statesville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Marion, Ohio, United States
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Perrysburg, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Bristol, Tennessee, United States
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Morristown, Tennessee, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Lakewood, Washington, United States
Unknown Facility
Mexico City, Mexico
Unknown Facility
Lima, Peru
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 9, 2005
Study Start
December 1, 2004
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
January 9, 2008
Record last verified: 2007-12