A study to test how well empagliflozin works in Japanese people with type 2 diabetes who are older than 65 years

A randomised, double-blind, placebo-controlled, parallel group, 52 weeks phase IV trial to evaluate efficacy and safety of oral, once daily empagliflozin in elderly Japanese patients with type 2 diabetes mellitus and insufficient glycaemic control

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080225321

Enrollment

128

Registered

2020-08-19

Start date

2020-10-13

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 : empagliflozin INN of investigational material : empagliflozin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investiga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Japanese patients with diagnosis of type 2 diabetes mellitus prior to informed consent 2. Age over 65 years at informed consent 3. B+G20MI over 22 kg/m2 etc.

Exclusion criteria

Exclusion criteria: 1. Treatment with insulin within 12 weeks prior to informed consent 2. Uncontrolled hyperglycaemia with a fasting glucose level >200 mg/dL (>11.1 mmol/L) during run-in period etc.

Design outcomes

Primary

Measure	Time frame
efficacy Change from baseline in glycosylated haemoglobin A1c (HbA1c) after 52 weeks of treatment	—

Secondary

Measure	Time frame
safety Change of body composition from baseline to Week 52 Change of grip strength from baseline to Week 52 Change of time in the 5-time chair stand test from baseline to Week 52	—

Countries

Japan

Outcome results

None listed

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