Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus

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.

Timeline

Start

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Primary completion

2016-07

Completion

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Outcome

Met primary endpoint

registry analysis (superiority test); Placebo/KAD-1229 vs KAD-1229/KAD-1229; p <0.001; Mean Difference (Final Values) -0.66 (95% CI -0.95 to -0.37); t-test, 2 sided NCT02154347 ↗

Drugs

Indications