MK-0431A/ONO-5435A Phase III Clinical Trial -Metformin Add-on Regimen Comparison Study in Japanese Patients with Type 2 Diabetes Mellitus

A Phase III, Randomized, Placebo and Active-Controlled, Double-Blind Clinical Trial to Study the Efficacy and Safety of the Addition of Metformin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Sitagliptin Monotherapy

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221725

Enrollment

337

Registered

2012-02-28

Start date

2012-02-28

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Type 2 Diabetes Mellitus

Interventions

investigational material(s) Generic name etc : Sitagliptin, Metformin INN of investigational material : Sitagliptin, Metformin Therapeutic category code : 396 Antidiabetic agents Dosage and Administra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Type 2 Diabetes Mellitus 2.Currently being treated with diet/exercise and on stable dose of sitagliptin for >=4 weeks, on any additional oral hypoglycemic agent (AHA) in the prior 8 weeks, and HbA1c >=6.0% and ==10 weeks, not on any additional oral AHA in the prior 8 weeks, and HbA1c >=6.5% and <10.0%

Exclusion criteria

Exclusion criteria: 1.Type 1 diabetes mellitus, secondary diabetes mellitus, or gestational diabetes mellitus

Design outcomes

Primary

Measure	Time frame
HbA1c	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026