Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 133
Healthy volunteers: no

Brief summary:
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

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Comparator: Placebo intervention 2: Sitagliptin intervention 3: Voglibose
Intervention descriptions: intervention 1: Placebo to sitagliptin once daily for 12 weeks (double-blind period) intervention 2: 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. intervention 3: All participants received a stable dose of voglibose, in

accordance with the package insert, throughout the study.

Protocol document: