The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
521
sitagliptin 100 mg oral tablet once daily for 54 weeks
sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks
placebo oral tablet once daily during Phase A (Weeks 0-18)
Change From Baseline in A1C at Week 18
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Time frame: Weeks 0-18
Change From Baseline in FPG at Week 18
The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.
Time frame: Weeks 0-18
Change From Baseline in A1C at Week 54
A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.
Time frame: Weeks 0-54
Change From Baseline in FPG at Week 54
The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.
Time frame: Weeks 0-54
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pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)