WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00147758
• 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 sulfonylurea 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: 2006-08
• Study Completion: 2006-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age 18-75 years, inclusive
• Diagnosed with type 2 diabetes
• Stable dose of sulfonylurea alone or in combination with other anti-diabetic medications for 90 days
• Hemoglobin A1c value 7.5% to 9.5%, inclusive
• C peptide > 0.5 ng/mL
• Prescribed ADA diet

Exclusion Criteria

• History of type 1 diabetes or ketoacidosis
• History of pancreatitis
• Uncontrolled hypertension
• Allergy or toxic response to colesevelam or any of its components
• Serum LDL-C < 60 mg/dL
• Serum TG > 500 mg/dL
• 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 fasting plasma glucose and fructosamine lowering efficacy;
To assess glycemic control response rate;
To assess the improvement in insulin sensitivity;
To assess the effect on C reactive protein;
To assess lipids and lipoproteins;
To assess the safety and tolerability of colesevelam hydrochloride as add-on therapy