Alogliptin tablets special drug use surveillance: Mild type 2 diabetes mellitus

Nesina tablets special drug use surveillance: "Mild type 2 diabetes mellitus"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080222234

Enrollment

19192

Registered

2013-09-24

Start date

2011-08-03

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 : Nesina tablet (alogliptin) INN of investigational material : Alogliptin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with HbA1c (JDS value) less and equal 7.0% at the time of enrolment (within 3 months before initiation of Nesina therapy), regardless of the use of antidiabetic medication.

Exclusion criteria

Exclusion criteria: Patients contraindicated for Nesina (1) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus. (2) Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury. (3) Patients with a history of hypersensitivity to any ingredient of Nesina.

Design outcomes

Primary

Measure	Time frame
safety Percentage of Participants who had One or More Adverse Reactions Time Frame: Up to Month 36 efficacy Change from Baseline in Glycosylated Hemoglobin (HbA1c) Time Frame: Baseline, and final assessment point (up to Month 36)	—

Secondary

Measure	Time frame
efficacy Change from Baseline in Fasting Blood Glucose Level Time Frame: Baseline, and final assessment point (up to Month 36)	—

Countries

Japan

Outcome results

None listed

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