MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: MK-0431/ONO-5435

Study type: Interventional

Funder types: Industry

Identifiers

NCT00854035

ONO-5435-15

Details and patient eligibility

About

This Phase III clinical trial will examine the efficacy, safety, and tolerability 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 insulin monotherapy.

Enrollment: 266 patients

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 insulin monotherapy

Exclusion criteria

• Patients with Type 1 Diabetes Mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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266 participants in 2 patient groups, including a placebo group

E

Experimental group

Treatment:

Drug: MK-0431/ONO-5435

Drug: MK-0431/ONO-5435

P

Placebo Comparator group

Treatment:

Drug: MK-0431/ONO-5435

Drug: MK-0431/ONO-5435