WelChol® With Metformin in Treating Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00147719
• Lead Sponsor: Daiichi Sankyo

Brief Summary

The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in combination with other anti-diabetic drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age 18-75 years, inclusive
• Diagnosed with type 2 diabetes
• Hemoglobin (HbA1c) between 7.5% to 9.5%
• Prescribed an ADA accepted diet
• Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1

Exclusion Criteria

• History of type 1 diabetes or ketoacidosis
• History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment
• History of pancreatitis
• Uncontrolled hypertension
• Recent severe cardiovascular disease
• Allergy or toxic response to colesevelam or any of its components
• Body mass index (BMI) >45 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy

Secondary Outcome Measures

Name	Time	Method
To assess the effect on high sensitivity C-reactive protein;
To assess the improvement in insulin sensitivity;
To assess the fasting plasma glucose and fructosamine lowering effect;
To assess the glycemic control response rate;
To assess the improvement in lipids, and lipoproteins;
To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy

Trial Locations

Locations (1)

CRO; 🇺🇸 Jonesboro, Arkansas, United States