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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00363844

ONO-5435-10

Details and patient eligibility

About

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

Enrollment: 209 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes mellitus on diet and exercise therapy

Exclusion criteria

• Patients with type 1 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

209 participants in 1 patient group

E

Experimental group

Treatment:

Drug: Sitagliptin phosphate