The purpose of this study is to examine the safety and tolerability of sitagliptin 100 mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks
Participants will continue pre-study dose of metformin tablet(s) \>=1000 per day
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.
Time frame: Baseline and Week 6
Percentage of Participants Who Experienced at Least One Adverse Event
An 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 8 weeks (including 14 days after final dose of study drug)
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.
Time frame: Up to 6 weeks
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
Time frame: Baseline and Week 6
Change From Baseline in Total Cholesterol (TC)
Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
Time frame: Baseline and Week 6
Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)
Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
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Time frame: Baseline and Week 6
Change From Baseline in Triglycerides (TG)
Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).
Time frame: Baseline and Week 6
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.
Time frame: Baseline and Week 6