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

Daiichi Sankyo780 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

780

Conditions

Type 2 Diabetes

Interventions

Colesevelam hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (64)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

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Tuscumbia, Alabama, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Searcy, Arkansas, United States

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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

...and 54 more locations