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  • Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)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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Page 1 of 1 (1 locations)

1

San Diego VMC

San Diego, California, United States, 92161

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