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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Empagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empagliflozin<br> | Drug: Empagliflozin<br>* Empagliflozin<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycated hemoglobin (HbA1c) from baseline after 52 weeks of | HbA1c will be measured in the units of % and mmol/mol at all clinical visits; the primary endpoint will use units of %. | up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of muscle mass from baseline to Week 52 |  | Up to 52 weeks | 
| Change of body fat measurement from baseline to Week 52 |  | Up to 52 weeks | 
| Change of lean body mass from baseline to Week 52 |  | Up to 52 weeks | 
| Change of total body water from baseline to Week 52 |  | Up to 52 weeks | 
| Change of bone mineral content from baseline to Week 52 | Bone mineral content: Estimated bone mass in kilogram will be measured as a proxy for bone mineral content by bioelectrical impedance analysis (BIA). BIA is a tool for assessing body composition by passing a very small current through the body assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. | Up to 52 weeks | 
| Change of skeletal muscle index from baseline to Week 52 |  | Up to 52 weeks | 
| Change of grip strength from baseline to Week 52 |  | Up to 52 weeks | 
| Change of time in the 5-time chair stand test from baseline to Week 52 |  | Up to 52 weeks |