| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin), A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures., Baseline and Week 16|Number of Participants Who Experienced at Least One Adverse Event (AE), Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product., Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs|Number of Participants Who Discontinued Study Drug Due to an Adverse Event, Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product., Up to 16 weeks | Secondary: Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin), A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures., Baseline and Week 16|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16, Change from baseline reflects the Week 16 value minus the Week 0 value., Baseline and Week 16|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in Total Cholesterol (TC) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in Triglycerides (TG) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percentage of Participants With A1C Level <7% at Week 16, Percentage of participants achieving glycemic goal (A1C \<7%) after 16 weeks of treatment. Data as observed., Week 16
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