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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001382

Enrollment

240

Registered

2008-10-01

Start date

2007-11-01

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 12.5mg once daily before breakfast for 12 weeks. Pioglitazone will be administered as 15 mg or 30 mg once daily before breakfast for 28 weeks(16 weeks screen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The subject has been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 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 14 weeks after the initiation of the observation period (Week -2) 3)The subject is receiving specific diet and exercise therapies (if any) during the observation period

Exclusion criteria

Exclusion criteria: 1)The subject has taken other diabetic medications than pioglitazone within 16 weeks before the initiation of the treatment period (Week 0) 2)The subject with a history or symptoms of cardiac failure

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