NCT00854035
Completed
Phase 3
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 MK-0431/ONO-5435 in Japansese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Insulin Monotherapy
Overview
- Phase
- Phase 3
- Intervention
- MK-0431/ONO-5435
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Ono Pharmaceutical Co. Ltd
- Enrollment
- 266
- Locations
- 7
- Primary Endpoint
- HbA1c
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This Phase III clinical trial will examine the efficacy, safety, and tolerability of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Japanese Patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy
Exclusion Criteria
- •Patients with Type 1 Diabetes Mellitus
Arms & Interventions
E
Intervention: MK-0431/ONO-5435
P
Intervention: MK-0431/ONO-5435
Outcomes
Primary Outcomes
HbA1c
Time Frame: 16 weeks
Safety and Tolerability
Time Frame: 16 weeks and 52 weeks
Secondary Outcomes
- 2 hour post-meal glucose(16 weeks)
- Fasting plasma glucose(16 weeks)
Study Sites (7)
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