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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151762

Enrollment

780

Registered

2005-09-09

Start date

2004-12-31

Completion date

2007-07-31

Last updated

2008-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Open label, Diabetes Mellitus, Long term safety study, extension study

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.

Interventions

DRUGColesevelam hydrochloride

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To evaluate safety and tolerability of colesevelam hydrochloride as add-on therapy	—

Secondary

Measure	Time frame
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	—

Countries

Mexico, Peru, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026