A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,615
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.
Matching placebo to sitagliptin orally once daily for 54 weeks.
Change From Baseline in Hemoglobin A1C (A1C) at Week 24
A1C represents the percentage of glycosylated hemoglobin.
Time frame: Baseline and Week 24
Change From Baseline in A1C at Week 54
A1C represents the percentage of glycosylated hemoglobin.
Time frame: Baseline and Week 54
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24
PMG was measured using the Meal Tolerance Test (MTT).
Time frame: Baseline and Week 24
Change From Baseline in FPG at Week 54
Time frame: Baseline and Week 54
Change From Baseline in 2-Hour PMG at Week 54
PMG was measured using the Meal Tolerance Test (MTT).
Time frame: Baseline and Week 54
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks.
Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.