This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.
Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment
Safety \& tolerability were measured in terms of the # of participants with \>=1 adverse event (AE), \>=1 drug-related AE, \>=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.
Time frame: 4 weeks
Change From Baseline in Fasting Plasma Glucose at Week 4
Calculated as the mean change from baseline in fasting plasma glucose at Week 4.
Time frame: Baseline and Week 4
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