At a glance
ClinicalIndex Comparison Record- ✓Japanese patients with type 2 diabetes mellitus
- ✓Inadequate glycemic control on diet/exercise therapy and voglibose monotherapy
- ✕History of type 1 diabetes mellitus
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Placebo-controlled, Double-blind Clinical Trial and Subsequent Open-label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Voglibose Monotherapy
In Brief
A Phase 3 clinical trial evaluating Comparator: Placebo, Sitagliptin, and 1 other intervention for Diabetes Mellitus, Non-Insulin-Dependent. Completed, enrolled 133 participants.
Detailed 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
Study Details
Timeline
Interventions
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.