A Study to Test How Well Empagliflozin Works in Japanese People With Type 2 Diabetes Who Are Older Than 65 Years

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Empagliflozin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04531462

1245-0218

Details and patient eligibility

About

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.

Enrollment

129 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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