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

NCT ID: NCT04531462

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2022-08-26

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Empagliflozin 10 mg

Group Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

Empagliflozin

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Empagliflozin

Empagliflozin

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Meitetsu Hospital

Aichi, Nagoya, , Japan

Chubu Rosai Hospital

Aichi, Nagoya, , Japan

Daido Hospital

Aichi, Nagoya, , Japan

Seino Internal Medicine Clinic

Fukushima, Koriyama, , Japan

Gifu University Hospital

Gifu, Gifu, , Japan

Watanabe Clinic

Hyogo, Nishinomiya, , Japan

Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

Kanagawa, Yokohama, , Japan

Medical Corporation KEISEIKAI Kajiyama Clinic

Kyoto, Kyoto, , Japan

Medical Corporation Hayashi Katagihara Clinic

Kyoto, Kyoto, , Japan

Iryouhouijneiwakai Minamiakatsuka Clinic

Mito, Ibaraki, , Japan

Moriya Keiyu Hospital

Moriya, Ibaraki, , Japan

North Alps Medical Center Azumi Hospital

Nagano, Kitaazumi-gun, , Japan

Asama Nanroku Komoro Medical Center

Nagano, Komoro, , Japan

Koshigaya Municipal Hospital

Saitama, Koshigaya, , Japan

Dojinkinenkai Meiwa Hospital

Tokyo, Chiyoda-ku, , Japan

Tokyo Asbo Clinic

Tokyo, Chuo-ku, , Japan

Shinagawa East one Medical Clinic

Tokyo, Minato-ku, , Japan

Ikebukuro Metropolitan Clinic

Tokyo, Toshima-ku, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 33827843 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

1245-0218

Identifier Type: -

Identifier Source: org_study_id