A Phase 2/3 Study of SYR-322 as an Add-on to a Metformin

A Phase 2/3 Study of SYR-322 as an Add-on to a Metformin - A Phase 2/3 Study of SYR-322 as an Add-on to a Metformin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001394

Enrollment

240

Registered

2009-04-01

Start date

2008-08-01

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

Each subject will orally receive SYR-322 12.5 mg once daily before breakfast. Metformin will be administered orally 500 mg/day, twice daily after meal, or 750 mg thrice daily after meal for 24 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The subject has been taking metformin at a stable dose regimen for at least 12 weeks prior to the initiation of the treatment period (Week 0). 2)The subject has an HbA1c of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).

Exclusion criteria

Exclusion criteria: 1)The subject has taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0). 2)The subject with a history or symptoms of lactic acidosis.

Design outcomes

Primary

Measure	Time frame
HbA1c change at the completion of treatment from baseline	—

Countries

Japan

Outcome results

None listed

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