Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus HbA1c
Enrollment: 178

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.

Detailed description:

Arms:
arm 1: Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study. arm 2: Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.

Interventions: intervention 1: KAD-1229 intervention 2: Placebo intervention 3: Insulin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: