Efficacy and Safety Study of Pioglitazone Combined With Metformin on Metabolic Syndrome in Subjects With Type 2 Diabetes

PHASE3CompletedINTERVENTIONAL
Enrollment

418

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Diabetes Mellitus
Interventions
DRUG

Pioglitazone and Metformin

Pioglitazone 15 mg, tablets, orally, two-times daily and metformin stable dose, orally, three-times daily for 4 weeks; then increased to pioglitazone 15 mg, tablets, orally, three-times daily and metformin stable dose, orally, three-times daily for up to 20 weeks.

DRUG

Metformin

Pioglitazone placebo-matching tablets, orally, two-times daily and metformin stable dose, orally, three-times daily for 4 weeks; then increased to pioglitazone placebo-matching tablets, orally, three-times daily and metformin stable dose, orally, three-times daily for up to 20 weeks.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY