The purpose of this clinical 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
741
Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
Change From Baseline in 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: Weeks 0-24
Change From Baseline in FPG at Week 24
Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
Time frame: Weeks 0-24
Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24
Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.
Time frame: Weeks 0-24
Change From Baseline in A1C at Week 104
A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.
Time frame: Weeks 0-104
Change From Baseline in FPG at Week 104
Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.
Time frame: Weeks 0-104
Change From Baseline in 2-hr PMG at Week 104
Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.
Time frame: Weeks 0-104
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.