Effect of Insulin Sensitizer Therapy on Atherothrombotic and Inflammatory Profiles Associated With Insulin Resistance

PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Type 2 DiabetesInsulin ResistanceMetabolic Syndrome
Interventions
DRUG

metformin

To minimize side effects the metformin will be initiated at 500 mg twice daily with meals and increased to 1 gm twice daily with meals after two weeks and continue to a total of 3 months of dosing.

DRUG

pioglitazone

To minimize side effects, the pioglitazone will be initiated at 30 mg daily and increased to 45 mg daily after two weeks, and continue to a total of 3 months of dosing.

DRUG

Placebo

Placebo tablets matching the metformin and pioglitazone tablets are given in the same regimen as the active drug arm for 3 months.

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

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

NIH

collaborator

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

collaborator

National Center for Research Resources (NCRR)

NIH

lead

Mayo Clinic

OTHER