Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients
NCT02314637 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-01-05
Summary
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.
Conditions
Interventions
- DRUG
-
Teneligliptin
Teneligliptin for 52 weeks
- DRUG
-
Teneligliptin + Sulfonylurea
Teneligliptin for 52 weeks in combination with sulfonylurea
Sponsors & Collaborators
-
Tanabe Pharma Corporation
lead INDUSTRY
Principal Investigators
-
Takashi Kadowaki, Professor · Tokyo University
-
Kazuoki Kondo, MD · Tanabe Pharma Corporation
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2011-07-31
- Completion
- 2011-07-31
Countries
- Japan
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