MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus
Phase 3
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: MK-0431/ONO-5435
- Registration Number
- NCT00854035
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 266
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E MK-0431/ONO-5435 - P MK-0431/ONO-5435 -
- Primary Outcome Measures
Name Time Method HbA1c 16 weeks Safety and Tolerability 16 weeks and 52 weeks
- Secondary Outcome Measures
Name Time Method 2 hour post-meal glucose 16 weeks Fasting plasma glucose 16 weeks
Trial Locations
- Locations (7)
Kinki Region
🇯🇵Kinki, Japan
Hokuriku Region
🇯🇵Hokuriku, Japan
Kyushu Region
🇯🇵Kyushu, Japan
Tohoku Region
🇯🇵Tohoku, Japan
Chubu Region
🇯🇵Chubu, Japan
Chugoku Region
🇯🇵Chugoku, Japan
Kanto Region
🇯🇵Kanto, Japan