Status:
COMPLETED
Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes
Lead Sponsor:
Daiichi Sankyo
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Inclusion/Rollover Criteria:
- Patients who have completed studies WEL-301, WEL-302, or WEL-303 with treatment compliance at least 80%
- Patients who have completed studies WEL-301, WEL-302, or WEL-303 who have not met withdrawal criteria
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT00151762
Start Date
December 1 2004
End Date
July 1 2007
Last Update
January 9 2008
Active Locations (64)
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1
Birmingham, Alabama, United States
2
Tuscumbia, Alabama, United States
3
Jonesboro, Arkansas, United States
4
Little Rock, Arkansas, United States