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

Conditions: Diabetes Mellitus, Type 2

Summary: this study is to assess the efficacy of empagliflozin 10 mg after 52 weeks compared to placebo in elderly patients with type 2 diabetes mellitus (t2dm) and to explore if empagliflozin has any impact on patient physical condition compared to placebo in elderly patients with t2dm.


Eligibility criteria:
inclusion criteria: * japanese (defined as patient has parents who are japanese) patients with diagnosis of type 2 diabetes mellitus (t2dm) prior to informed consent * glycated hemoglobin (hba1c) ≥7.0% and ≤10.0% for patients at visit 1 (screening). if the patient is on treatment with oral antidiabetic drug(s) potentially associated with severe hypoglycaemia (e.g., sulfonylurea or glinides), the following hba1c value is used as criterion * hba1c ≥7.5% and ≤10.0% for age ≥65 and \<75 * hba1c ≥8.0% and ≤10.0% for age ≥75 * patients on diet and exercise regimen who are drug-naïve (drug-naïve is defined as no antidiabetic drugs for at least 12 weeks prior to informed consent) or on treatment with any oral antidiabetic drug (oad) other than glucagon-like peptide-1 (glp-1) agonists and sodium-glucose cotransporter 2 (sglt-2) inhibitor. antidiabetic therapy has to be unchanged for 12 weeks prior to randomisation (any thiazolidinedione therapy has to be unchanged for at least 18 weeks prior to informed consent). * age ≥65 years at informed consent * bmi ≥22 kg/m2 at visit 1 (screening) * male or post-menopausal (a point in time 12 months after a woman's last period) female patients * patient signed and dated written informed consent in accordance with international conference on harmonization (ich)- good clinical practice (gcp) and local legislation prior to admission to the trial exclusion criteria: * uncontrolled hyperglycaemia with a fasting glucose level \>200 milligram per deciliter (mg/dl) (\>11.1 millimol per liter (mmol/l)) during run-in period * treatment with insulin within 12 weeks prior to informed consent * impaired cognitive ability as supported by mini mental state examination (mmse-j, defined as ≤23) and verified by the investigator at screening * acute coronary syndrome (st-elevation myocardial infarction \[stemi\], non-stemi, and unstable angina pectoris), stroke or transient ischemic attack within 12 weeks prior to informed consent * indication of liver disease, defined by serum levels of either alanine aminotransferase (alt = serum glutamic-pyruvic transaminase \[sgpt\]), aspartate aminotransferase (ast = serum glutamic-oxaloacetic transaminase\[sgot\]), or alkaline phosphatase (alp) above 3 x upper limit of normal (uln) as determined during screening and run-in period * impaired renal function, defined as estimated glomerular filtration rate (egfr) \<45 milliliter per minute per 1.73 square meter (ml/min/1.73 m2, severe renal impairment, modification of diet in renal disease (mdrd) formula) as determined during screening and run-in period * low grip strength defined as \<28 kilogram (kg) for male or as \<18 kg for female at screening * short length of calf circumference defined as \<34 centimeter (cm) for male or 33 cm for female at screening * further exclusion criteria apply