The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
701
Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)
Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
Change From Baseline in Hemoglobin A1C (A1C) at Week 24
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Time frame: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Change from baseline at Week 24 is defined as FPG at Week 24 minus FPG at Week 0.
Time frame: Baseline and Week 24
Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24
Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
Time frame: Baseline and Week 24
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Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period \[Phase A\], from Visit 5 (Week 6) to Visit 8 (Week 24)