Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 204
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with thiazolidinedione with an extension treatment for up to 52 weeks.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Placebo / Teneli (Teneligliptin) + pio (pioglitazone) intervention 2: Teneli / Teneli + pio
Intervention descriptions: intervention 1: Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. intervention 2: Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.

Protocol document: