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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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

Key facts

Study ID

NCT00147745

Run by

Daiichi Sankyo

People needed

36

Starts

2005-06-01

Expected to finish

2008-01-01

Last updated by the study team

2014-04-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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• Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)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

You may not qualify if…

• 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

Where it is running

• San Diego VMC — San Diego, California, United States

Full record on ClinicalTrials.gov

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