38
Participants
Start Date
August 31, 2009
Primary Completion Date
July 31, 2012
Study Completion Date
December 31, 2012
Colesevelam
Colesevelam hydrochloride; three 625mg tablets taken orally twice per day before breakfast and before the evening meal over a 12-week treatment period.
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.
Diet
Subjects were instructed to follow a weight maintenance diet (\~55% carbohydrate, 30% fat and 15% protein) for the 12 week study period.
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.
Mayo Clinic, Rochester
Lead Sponsor
Collaborators (1)
Daiichi Sankyo
INDUSTRY
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
National Center for Research Resources (NCRR)
NIH
Mayo Clinic
OTHER