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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151762
• Other study ID #: WEL-304
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: December 26, 2007
• Start date: December 2004
• Est. completion date: July 2007

Study information

• Verified date: December 2007
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPeru: General Directorate of Pharmaceuticals, Devices, and DrugsMexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial Summary

This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Colesevelam hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Inc.

Countries where clinical trial is conducted

United States,  Mexico,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy
Secondary	To assess the long-term effect on hemoglobin A1c
Secondary	To assess the long-term effect on fasting plasma glucose
Secondary	To assess effects on lipids and lipoproteins