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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001393

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. Glimepiride will be administered orally 1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and ev

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The subject has been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period. 2)The subject has been taking sulfonylurea at a stable dose regimen for at least 12 weeks prior to the initiation of the treatment period (Week 0). 3)The subject has an HbA1c of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).

Exclusion criteria

Exclusion criteria: The subject has taken other diabetic medications than sulfonylurea within 12 weeks before the initiation of the treatment period (Week 0).

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