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

MK-0431/ONO-5435 Phase III Clinical Study - Metformin Add-On Study for Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00363948

Enrollment

188

Registered

2006-08-15

Start date

2006-08-31

Completion date

Unknown

Last updated

2012-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

MK-0431, ONO-5435, Type 2 diabetes mellitus

Brief summary

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 metformin as monotherapy

Interventions

DRUGPlacebo

Double-blind period (12 wk); Placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD

DRUGSitagliptin phosphate

Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Patients with type 2 diabetes mellitus on diet/exercise therapy and metformin as monotherapy

Exclusion criteria

* Patients with type 1 diabetes mellitus

Design outcomes

Primary

Measure	Time frame
HbA1c	12 weeks
safety	52 weeks
tolerability	52 weeks

Secondary

Measure	Time frame
Plasma glucose	12 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026