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

• ClinicalTrials.gov Identifier: NCT04531462
• Recruitment Status: Active, not recruiting
• First Posted: August 28, 2020
• Last Update Posted: March 10, 2022
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: Empagliflozin; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 129 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 5, 2020
• Estimated Primary Completion Date: August 19, 2022
• Estimated Study Completion Date: August 26, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Empagliflozin	Drug: Empagliflozin; Empagliflozin
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change of muscle mass from baseline to Week 52 [ Time Frame: Up to 52 weeks ]
2. Change of body fat measurement from baseline to Week 52 [ Time Frame: Up to 52 weeks ]
3. Change of lean body mass from baseline to Week 52 [ Time Frame: Up to 52 weeks ]
4. Change of total body water from baseline to Week 52 [ Time Frame: Up to 52 weeks ]
5. Change of bone mineral content from baseline to Week 52 [ Time Frame: Up to 52 weeks ]

   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.

6. Change of skeletal muscle index from baseline to Week 52 [ Time Frame: Up to 52 weeks ]
7. Change of grip strength from baseline to Week 52 [ Time Frame: Up to 52 weeks ]
8. Change of time in the 5-time chair stand test from baseline to Week 52 [ Time Frame: Up to 52 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Japan

Meitetsu Hospital

Aichi, Nagoya, Japan, 451-8511

Chubu Rosai Hospital

Aichi, Nagoya, Japan, 455-8530

Daido Hospital

Aichi, Nagoya, Japan, 457-8511

Seino Internal Medicine Clinic

Fukushima, Koriyama, Japan, 963-8851

Gifu University Hospital

Gifu, Gifu, Japan, 501-1194

Watanabe Clinic

Hyogo, Nishinomiya, Japan, 662-0971

Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

Kanagawa, Yokohama, Japan, 231-0023

Medical Corporation KEISEIKAI Kajiyama clinic

Kyoto, Kyoto, Japan, 600-8898

Medical Corporation Hayashi Katagihara Clinic

Kyoto, Kyoto, Japan, 615-8125

Iryouhouijneiwakai Minamiakatsuka clinic

Mito, Ibaraki, Japan, 311-4153

Moriya Keiyu Hospital

Moriya, Ibaraki, Japan, 302-0118

North Alps Medical Center Azumi Hospital

Nagano, Kitaazumi-gun, Japan, 399-8695

Asama Nanroku Komoro Medical Center

Nagano, Komoro, Japan, 384-8588

Koshigaya Municipal Hospital

Saitama, Koshigaya, Japan, 343-8577

Dojinkinenkai Meiwa Hospital

Tokyo, Chiyoda-ku, Japan, 101-0041

Tokyo Asbo Clinic

Tokyo, Chuo-ku, Japan, 104-0031

Shinagawa East one Medical Clinic

Tokyo, Minato-ku, Japan, 108-0075

Ikebukuro Metropolitan Clinic

Tokyo, Toshima-ku, Japan, 171-0021

Sponsors and Collaborators

Boehringer Ingelheim

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT04531462
• Other Study ID Numbers: 1245-0218
• First Posted: August 28, 2020
• Last Update Posted: March 10, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'.For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'
• URL: https://www.mystudywindow.com/msw/datasharing

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Empagliflozin; Sodium-Glucose Transporter 2 Inhibitors; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Physiological Effects of Drugs