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Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.
Details
| Lead sponsor | Tanabe Pharma Corporation |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 462 |
| Start date | 2011-02 |
| Completion | 2012-09 |
Conditions
- Type 2 Diabetes Mellitus
Interventions
- teneligliptin
- glinide
- biguanide
- alpha-glucosidase inhibitor
Primary outcomes
- Number of Participants With Adverse Events — 52 Weeks
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Countries
Japan