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

Boehringer Ingelheim18 sites in 1 country129 target enrollmentOctober 5, 2020

ConditionsDiabetes Mellitus, Type 2

InterventionsEmpagliflozin Placebo

Overview

Phase: Phase 4
Intervention: Empagliflozin
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Enrollment: 129
Locations: 18
Primary Endpoint: Change in HbA1c From Baseline After 52 Weeks of Treatment
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 5, 2020

End Date

August 26, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

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

Arms & Interventions

Empagliflozin 10 mg

Intervention: Empagliflozin

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change in HbA1c From Baseline After 52 Weeks of Treatment

Time Frame: Change in HbA1c from baseline after 52 weeks of treatment was calculated using the MMRM model which is a longitudinal analyses and it incorporates HbA1c values from baseline and after 4 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks of treatment.

Change in glycated hemoglobin (HbA1c) (in units of %) from baseline after 52 weeks of treatment was modelled using a restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) which included fixed classification effects for treatment, gender, baseline renal function, visit and visit-by-treatment interaction, and a linear covariate for baseline HbA1c and age. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication.The Least Squares Mean (Standard Error) after 52 weeks of treatment is reported.

Secondary Outcomes

Change of Body Fat Measurement From Baseline to Week 52(At baseline and at Week 52)
Change of Lean Body Mass From Baseline to Week 52(At baseline and at Week 52.)
Change of Muscle Mass From Baseline to Week 52(At baseline and at Week 52)
Change of Total Body Water From Baseline to Week 52(At baseline and at Week 52.)
Change of Bone Mineral Content From Baseline to Week 52(At baseline and at Week 52.)
Change of Skeletal Muscle Index From Baseline to Week 52(At baseline and at Week 52.)
Change of Time in the 5-time Chair Stand Test From Baseline to Week 52(At baseline and at Week 52.)
Change of Grip Strength From Baseline to Week 52(At baseline and at Week 52.)