The Effect of Welchol on Glucose Metabolism in Type 2 Diabetics

PHASE4CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

July 31, 2012

Study Completion Date

December 31, 2012

Conditions
Type 2 Diabetes
Interventions
DRUG

Colesevelam

Colesevelam hydrochloride; three 625mg tablets taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period.

OTHER

Placebo

Three placebo tablets matching the active drug colesevelam in appearance, taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period.

BEHAVIORAL

Diet

Subjects were instructed to follow a weight maintenance diet (\~55% carbohydrate, 30% fat and 15% protein) for the 12 week study period.

DRUG

Metformin

Subjects continued to take their pre-study therapeutic doses of metformin (Metformin 500mg tablets taken by mouth twice daily for a total daily dose of 1000 to 2000 mg) through the 12 week study period.

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

National Center for Research Resources (NCRR)

NIH

lead

Mayo Clinic

OTHER