MK-0431/ONO-5435 Phase III Clinical Study - Metformin Add-On Study for Patients With Type 2 Diabetes Mellitus

NCT00363948 Phase 3 COMPLETED

The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and metformin as monotherapy

Details

Lead sponsor	Ono Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	COMPLETED
Enrolment	188
Start date	2006-08

Conditions

• Type 2 Diabetes Mellitus

Interventions

• Placebo
• Sitagliptin phosphate

Primary outcomes

• HbA1c — 12 weeks
• safety — 52 weeks
• tolerability — 52 weeks

Countries

Japan