Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Colesevelam Hydrochloride; Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Patients between the ages of 18 - 75, inclusive

• Diagnosed with type 2 diabetes

• Hemoglobin A1c value greater than or equal to 8.0%

• Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)

• Overweight, obese (body mass index 25-45 kg/m2)

Exclusion Criteria:

• Change of dose of lipid or blood pressure lowering therapy within past three months

• Previous treatment with colesevelam for hyperlipidemia

• Serum triglyceride greater than 500 mg/dL

• Serum low density lipoprotein-cholesterol less than 60 mg/dL