The purpose of this study is to assess the efficacy and safety of sitagliptin/simvastatin fixed-dose combination (FDC) in participants with T2DM who have inadequate glycemic control while on metformin monotherapy. The primary hypothesis of this study is that after 16 weeks of therapy, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with sitagliptin/simvastatin FDC is non-inferior compared to sitagliptin alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
299
Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet
Sitagliptin 100 mg tablet
Simvastatin 40 mg tablet
Matching placebo to sitagliptin 100 mg tablet
Matching placebo to simvastatin 40 mg tablet
Matching placebo to sitagliptin 100 mg/simvastatin 40 mg FDC tablet
Participants will continue on their stable, pre-screening metformin daily dose of \>= 1500 mg for at least 12 weeks prior to randomization and during the study
Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 16 weeks
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.
Time frame: 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.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: 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.
Time frame: Week 16
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