Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
Information source: Daiichi Sankyo Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Colesevelam (Drug); Colesevelam matching placebo (Drug); Insulin glargine (Lantus) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Daiichi Sankyo Inc.
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
Clinical Details
Official title: Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: - To evaluate the effect of WelChol® on hepatic insulin sensitivity- To evaluate the acute effect of WelChol®, single or multi dose, on oral glucose absorption
Secondary outcome: - To evaluate the acute effect of WelChol®, single or multidose, on oral glucose absorption - To evaluate the effect of WelChol® on hemoglobin A1c
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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be withdrawn)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 (BMI 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 LDL-C less than 60 mg/dL
Locations and Contacts
San Diego VMC, San Diego, California 92161, United States
Additional Information
Starting date: May 2005
Ending date: January 2008
Last updated: April 10, 2008
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