Conditions: Type 2 Diabetes
Keywords: insulin resistance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 324
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.

Detailed description:

Arms:
arm 1: Teneligliptin 10 mg, orally, once daily arm 2: Teneligliptin 20 mg, orally, once daily arm 3: Teneligliptin 40 mg, orally, once daily arm 4: Teneligliptin placebo-matching tablets, orally, once daily

Interventions: intervention 1: Teneligliptin 10mg intervention 2: Teneligliptin 20 mg intervention 3: Teneligliptin 40 mg intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: