Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on long-term use in type 2 diabetes mellitus patients with renal or hepatic impairment or advanced age"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223922

Enrollment

1026

Registered

2018-06-01

Start date

2017-02-28

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 : Alogliptin and Metformin hydrochloride INN of investigational material : Alogliptin Benzoate, Metformin Hydrochloride Therapeutic category code : 396 Ant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants should meet one or more of the following: 1. Have renal impairment (mild) 2. Have hepatic impairment (mild or moderate) 3. Elderly (aged 65 years or more)

Exclusion criteria

Exclusion criteria: Participants with any contraindication for study drug.

Design outcomes

Primary

Measure	Time frame
safety Percentage of Participants Who Had One or More Adverse Events Time Frame: Up to 12 months An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	—

Secondary

Measure	Time frame
efficacy Change from Baseline in Glycosylated Hemoglobin (HbA1c) Timeframe: Baseline, up to final assessment point (up to Month 12) The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline. efficacy Change from Baseline in Fasting Blood Glucose Timeframe: Baseline, up to final assessment point (up to Month 12) The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline. efficacy Change from Baseline in Fasting Insulin Level Timeframe: Baseline, up to final assessment point (up to Month 12) The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.	—

Measure

Time frame

efficacy Change from Baseline in Glycosylated Hemoglobin (HbA1c) Timeframe: Baseline, up to final assessment point (up to Month 12) The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline. efficacy Change from Baseline in Fasting Blood Glucose Timeframe: Baseline, up to final assessment point (up to Month 12) The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline. efficacy Change from Baseline in Fasting Insulin Level Timeframe: Baseline, up to final assessment point (up to Month 12) The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.

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Countries

Japan

Outcome results

None listed

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