A Phase 2/3 Study of SYR-322 as an Add-on to an Alpha-Glucosidase Inhibitor

A Phase 2/3 Study of SYR-322 as an Add-on to an Alpha-Glucosidase Inhibitor - A Phase 2/3 Study of SYR-322 as an Add-on to an Alpha-Glucosidase Inhibitor

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001381

Enrollment

210

Registered

2008-10-01

Start date

2007-02-01

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. Voglibose 0.2mg will also be administered orally three times daily before each meal for 20 weeks(8 weeks scr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The subject has been taking a stable dosage regimen of an Alpha-glucosidase inhibitor for the last 4 weeks or longer prior to the initiation of screening period(week -8) and during the screening period. 2)The subject has an HbA1c value of 6.5% or more and below 10.0% at 4 weeks after the initiation of screening period (week -4). 3)The subject is receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (week -8).

Exclusion criteria

Exclusion criteria: The subject has taken any antidiabetic medications except Alpha-glucosidase inhibitors within the last 4 weeks prior to the initiation of screening period(week -8) and during screening period.

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