Clinical trial NCT04531462: A Study to Test How Well Empagliflozin Works in Japanese People With Type 2 Diabetes Who Are Older Than 65 Years
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 129
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in HbA1c From Baseline After 52 Weeks of Treatment
timeFrame: 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.
Secondary outcomes:
measure: Change of Muscle Mass From Baseline to Week 52
timeFrame: At baseline and at Week 52
measure: Change of Body Fat Measurement From Baseline to Week 52
timeFrame: At baseline and at Week 52
measure: Change of Lean Body Mass From Baseline to Week 52
timeFrame: At baseline and at Week 52.
measure: Change of Total Body Water From Baseline to Week 52
timeFrame: At baseline and at Week 52.
measure: Change of Bone Mineral Content From Baseline to Week 52
timeFrame: At baseline and at Week 52.
measure: Change of Skeletal Muscle Index From Baseline to Week 52
timeFrame: At baseline and at Week 52.
measure: Change of Grip Strength From Baseline to Week 52
timeFrame: At baseline and at Week 52.
measure: Change of Time in the 5-time Chair Stand Test From Baseline to Week 52
timeFrame: At baseline and at Week 52.
Other outcomes:
Locations:
city: Aichi, Nagoya
country: Japan
facility: Meitetsu Hospital
city: Aichi, Nagoya
country: Japan
facility: Chubu Rosai Hospital
city: Aichi, Nagoya
country: Japan
facility: Daido Hospital
city: Fukushima, Koriyama
country: Japan
facility: Seino Internal Medicine Clinic
city: Gifu, Gifu
country: Japan
facility: Gifu University Hospital
city: Hyogo, Nishinomiya
country: Japan
facility: Watanabe Clinic
city: Kanagawa, Yokohama
country: Japan
facility: Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
city: Kyoto, Kyoto
country: Japan
facility: Medical Corporation KEISEIKAI Kajiyama Clinic
city: Kyoto, Kyoto
country: Japan
facility: Medical Corporation Hayashi Katagihara Clinic
city: Mito, Ibaraki
country: Japan
facility: Iryouhouijneiwakai Minamiakatsuka Clinic
city: Moriya, Ibaraki
country: Japan
facility: Moriya Keiyu Hospital
city: Nagano, Kitaazumi-gun
country: Japan
facility: North Alps Medical Center Azumi Hospital
city: Nagano, Komoro
country: Japan
facility: Asama Nanroku Komoro Medical Center
city: Saitama, Koshigaya
country: Japan
facility: Koshigaya Municipal Hospital
city: Tokyo, Chiyoda-ku
country: Japan
facility: Dojinkinenkai Meiwa Hospital
city: Tokyo, Chuo-ku
country: Japan
facility: Tokyo Asbo Clinic
city: Tokyo, Minato-ku
country: Japan
facility: Shinagawa East one Medical Clinic
city: Tokyo, Toshima-ku
country: Japan
facility: Ikebukuro Metropolitan Clinic
Study officials:
References:
citation: Yabe D, Shiki K, Suzaki K, Meinicke T, Kotobuki Y, Nishida K, Clark D, Yasui A, Seino Y. Rationale and design of the EMPA-ELDERLY trial: a randomised, double-blind, placebo-controlled, 52-week clinical trial of the efficacy and safety of the sodium-glucose cotransporter-2 inhibitor empagliflozin in elderly Japanese patients with type 2 diabetes. BMJ Open. 2021 Apr 7;11(4):e045844. doi: 10.1136/bmjopen-2020-045844.