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

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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

266 participants in 2 patient groups, including a placebo group

E
Experimental group
Treatment:
Drug: MK-0431/ONO-5435
P
Placebo Comparator group
Treatment:
Drug: MK-0431/ONO-5435

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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