Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 148
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an extension treatment for up to 52 weeks.

Detailed description:

Arms:
arm 1: Teneligliptin for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin. arm 2: Placebo for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.

Interventions: intervention 1: Teneli (Teneligliptin) intervention 2: Placebo intervention 3: Insulin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: