Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sitagliptin phosphate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00363519

ONO-5435-09

Details and patient eligibility

About

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 glimepiride as monotherapy

Enrollment: 195 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Type 2 diabetes mellitus on diet/exercise therapy and glimepiride as monotherapy

Exclusion criteria

• Patients with Type 1 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 2 patient groups, including a placebo group

P

Placebo Comparator group

Treatment:

Drug: Placebo

E

Experimental group

Treatment:

Drug: Sitagliptin phosphate