A study in subjects with impaired glucose tolerance (IGT) to evaluate effects of AO-128 on prevention of type 2 diabetes mellitus (Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison)

A study in subjects with impaired glucose tolerance (IGT) to evaluate effects of AO-128 on prevention of type 2 diabetes mellitus (Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison) - A study in subjects with impaired glucose tolerance (IGT) to evaluate effects of Voglibose on prevention of type 2 diabetes mellitus (Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001109

Enrollment

1782

Registered

2008-04-07

Start date

2003-04-01

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

Impaired glucose tolerance (IGT)

Interventions

AO-128 (Voglibose) 0.2mg tab. tid At least 144 weeks, or by progression type 2 diabetes or improvement to normal OGTT Placebo tab. tid At least 144 weeks, or by progression type 2 diabetes or improv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Fasting plasma/serum glucose level: <125mg/dL and 2-hour plasma/serum glucose level: 140mg/dL to 199mg/dL in a 75g oral glucose tolerance test 2. HbA1c:<6.5%

Exclusion criteria

Exclusion criteria: 1. Patient has a history of diabetes mellitus 2. Patient with serious hepatic or renal disorders

Design outcomes

Primary

Measure	Time frame
Progression from IGT to type 2 diabetes mellitus	—

Countries

Japan

Outcome results

None listed

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