Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Mechanism of action insulin sensitivity
Eligibility 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greater than or equal to 8.0% Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn) Overweight, obese (body mass index 25-45 kg/m2) Exclusion Criteria: Change of dose of lipid or blood pressure lowering therapy within past three months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
Sites / Locations
- San Diego VMC
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Active Comparator
1
2
3
colesevelam 3.8g administered daily for 12 weeks
Colesevelam matching placebo for 12 weeks
open-label Insulin Glargine for 12 weeks