Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.

PHASE3CompletedINTERVENTIONAL
Enrollment

502

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

April 30, 2009

Study Completion Date

May 31, 2009

Conditions
Type 2 Diabetes MellitusHypercholesterolemiaPre-diabetes
Interventions
DRUG

Metformin HCl and Colesevelam Placebo

One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks

DRUG

Metformin HCl tablets and Colesevelam tablets

One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks

DRUG

Colesevelam placebo

Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks

DRUG

Colesevelam

Six colesevelam 625 mg tablets will be given once a day for 16 weeks.

Trial Locations (31)

70112

New Orleans

Unknown

Birmingham

Los Gatos

Tarzana

Ocala

Pocatello

Gary

Olive Branch

Dundee

West Seneca

Statesville

Kent

Marion

Portland

Corpus Christi

Dallas

San Antonio

Barranquilla

Bogota

Bucaramanga

Mumbai

Durgāpura

Bangalore

Kochi

Nashik

Las Palmas

Delegacion

Guadalajara

Monterrey

Hermosillo

Mérida

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY