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

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: MK-0431/ONO-5435; Drug: Placebo, MK-0431/ONO-5435

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01517321

Japic CTI-111668 (Registry Identifier)

ONO-5435-17

Details and patient eligibility

About

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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy

Exclusion criteria

• Patients with Type 1 Diabetes Mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

E

Experimental group

Treatment:

Drug: MK-0431/ONO-5435

P

Placebo Comparator group

Treatment:

Drug: Placebo, MK-0431/ONO-5435