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

MK-0431/ONO-5435 Phase III Clinical Study - Long-term Treatment Study for Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00363844

Enrollment

209

Registered

2006-08-15

Start date

2006-08-31

Completion date

Unknown

Last updated

2012-06-14

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

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

Interventions

DRUGSitagliptin phosphate

50 mg QD or 100 mg QD for 12 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Patients with type 1 diabetes mellitus

Design outcomes

Primary

Measure	Time frame
safety	52 weeks
tolerability	52 weeks

Secondary

Measure	Time frame
HbA1c	52 weeks
Plasma glucose	52 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026