AY4166 Phase III Long-term Study in Type 2 Diabetes Patients

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221882

Enrollment

120

Registered

2012-08-10

Start date

2012-08-10

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

investigational material(s) Generic name etc : AY4166 INN of investigational material : nateglinide Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational ma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes inadequately controlled with sitagliptin monotherapy - HbA1c (NGSP) in the range of ≥ 6.9 to < 8.9 % - postprandial plasma glucose 1 hour or 2hour after meal in the range of ≥ 200 mg/dL

Exclusion criteria

Exclusion criteria: - Type 1 diabetes mellitus - Patients with significant complications

Design outcomes

Primary

Measure	Time frame
Safety adverse events, laboratory evaluations, vital signs, 12-lead electrocardiograms	—

Secondary

Measure	Time frame
Efficacy HbA1c (NGSP)	—

Outcome results

None listed

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