WelChol® and Sulfonylurea in Treating Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Colesevelam Hydrochloride

Criteria

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