Status:
COMPLETED
Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
Lead Sponsor:
Daiichi Sankyo
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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- Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00147745
Start Date
June 1 2005
End Date
January 1 2008
Last Update
April 2 2014
Active Locations (1)
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1
San Diego VMC
San Diego, California, United States, 92161