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

NCT04531462 | Completed Phase 4 Results

• 1 other identifier: 1245-0218
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 18

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline After 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.

  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 (8)

• Change of Muscle Mass From Baseline to Week 52

  At baseline and at Week 52

• 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 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.

Study Arms (2)

Empagliflozin 10 mg

EXPERIMENTAL

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Empagliflozin DRUG

Empagliflozin

Empagliflozin 10 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (18)

Meitetsu Hospital

Aichi, Nagoya, 451-8511, Japan

Location

Chubu Rosai Hospital

Aichi, Nagoya, 455-8530, Japan

Location

Daido Hospital

Aichi, Nagoya, 457-8511, Japan

Location

Seino Internal Medicine Clinic

Fukushima, Koriyama, 963-8851, Japan

Location

Gifu University Hospital

Gifu, Gifu, 501-1194, Japan

Location

Watanabe Clinic

Hyogo, Nishinomiya, 662-0971, Japan

Location

Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

Kanagawa, Yokohama, 231-0023, Japan

Location

Medical Corporation KEISEIKAI Kajiyama Clinic

Kyoto, Kyoto, 600-8898, Japan

Location

Medical Corporation Hayashi Katagihara Clinic

Kyoto, Kyoto, 615-8125, Japan

Location

Iryouhouijneiwakai Minamiakatsuka Clinic

Mito, Ibaraki, 311-4153, Japan

Location

Moriya Keiyu Hospital

Moriya, Ibaraki, 302-0118, Japan

Location

North Alps Medical Center Azumi Hospital

Nagano, Kitaazumi-gun, 399-8695, Japan

Location

Asama Nanroku Komoro Medical Center

Nagano, Komoro, 384-8588, Japan

Location

Koshigaya Municipal Hospital

Saitama, Koshigaya, 343-8577, Japan

Location

Dojinkinenkai Meiwa Hospital

Tokyo, Chiyoda-ku, 101-0041, Japan

Location

Tokyo Asbo Clinic

Tokyo, Chuo-ku, 104-0031, Japan

Location

Shinagawa East one Medical Clinic

Tokyo, Minato-ku, 108-0075, Japan

Location

Ikebukuro Metropolitan Clinic

Tokyo, Toshima-ku, 171-0021, Japan

Location

Related Publications (1)

• 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.

  PMID: 33827843 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: October 5, 2020
• Primary Completion: August 19, 2022
• Study Completion: August 26, 2022
• Last Updated: May 2, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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'

Locations

JP (18)