The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
133
Placebo to sitagliptin once daily for 12 weeks (double-blind period)
Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period). Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.
All participants received a stable dose of voglibose, in accordance with the package insert, throughout the study.
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c \[National Glycohemoglobin Standardization Program; NGSP\] = HbA1c (JDS-HbA1c \[%\]) + 0.4%).
Time frame: Baseline and Week 12
Change From Baseline in 2-hour Postprandial Glucose at Week 12
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
Time frame: Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
Time frame: Baseline and Week 12
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