A 30-week extension to a 24-week study assessing the hemoglobin A1c (HbA1c)- and fasting plasma glucose (FPG)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (T2DM) with inadequate glycemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
317
Patients will receive combination therapy with blinded sitagliptin 100 mg q.d. (q.d. = once daily) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. Sitagliptin 100 mg q.d. and pioglitazone 45 mg q.d. will be administered as oral tablets.
Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. during the up to 30 week extension study. The placebo to match sitagliptin 100 mg q.d. (blinded) and open-label pioglitazone 45 mg q.d. will be administered as oral tablets.
Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54
HbA1c is measured as percent. Thus this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
Time frame: Baseline and 54 Weeks
Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) at Week 54
Change from baseline at Week 54 is defined as Week 54 minus Week 0.
Time frame: Baseline and Week 54
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Patients not meeting specific glycemic goals during the 30-week extension study will receive open-label metformin at a dose determined by the investigator.