Overview

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be withdrawn)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