MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes

NCT01517321 Phase 3 COMPLETED

This Phase III clinical trial will examine the safety, tolerability, and efficacy of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy.

Details

Lead sponsor	Ono Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	COMPLETED

Conditions

• Type 2 Diabetes

Interventions

• MK-0431/ONO-5435
• Placebo, MK-0431/ONO-5435

Primary outcomes

• Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability — 12 weeks and 52 weeks

Countries

Japan