Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00151762
• Lead Sponsor: Daiichi Sankyo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-26
• Last Update Posted: 2008-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy

Secondary Outcome Measures

Name	Time	Method
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