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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Empagliflozin

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Meitetsu Hospital
Chubu Rosai Hospital
Daido Hospital
Seino Internal Medicine Clinic
Gifu University Hospital
Watanabe Clinic
Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
Medical Corporation KEISEIKAI Kajiyama clinic
Medical Corporation Hayashi Katagihara Clinic
Iryouhouijneiwakai Minamiakatsuka clinic
Moriya Keiyu Hospital
North Alps Medical Center Azumi Hospital
Asama Nanroku Komoro Medical Center
Koshigaya Municipal Hospital
Dojinkinenkai Meiwa Hospital
Tokyo Asbo Clinic
Shinagawa East one Medical Clinic
Ikebukuro Metropolitan Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Empagliflozin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in glycated hemoglobin (HbA1c) from baseline after 52 weeks of

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

Change of muscle mass from baseline to Week 52

Change of body fat measurement from baseline to Week 52

Change of lean body mass from baseline to Week 52

Change of total body water from baseline to Week 52

Change of bone mineral content from baseline to Week 52

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.

Change of skeletal muscle index from baseline to Week 52

Change of grip strength from baseline to Week 52

Change of time in the 5-time chair stand test from baseline to Week 52

Full Information

NCT ID

NCT04531462

First Posted

August 26, 2020

Last Updated

March 13, 2023

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT04531462

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 5, 2020 (Actual)

Primary Completion Date

August 19, 2022 (Actual)

Study Completion Date

August 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

129 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Empagliflozin

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Empagliflozin

Intervention Description

Empagliflozin

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in glycated hemoglobin (HbA1c) from baseline after 52 weeks of

Description

HbA1c will be measured in the units of % and mmol/mol at all clinical visits; the primary endpoint will use units of %.

Time Frame

up to 52 weeks

Secondary Outcome Measure Information:

Title

Change of muscle mass from baseline to Week 52

Time Frame

Up to 52 weeks

Title

Change of body fat measurement from baseline to Week 52

Time Frame

Up to 52 weeks

Title

Change of lean body mass from baseline to Week 52

Time Frame

Up to 52 weeks

Title

Change of total body water from baseline to Week 52

Time Frame

Up to 52 weeks

Title

Change of bone mineral content from baseline to Week 52

Description

Time Frame

Up to 52 weeks

Title

Change of skeletal muscle index from baseline to Week 52

Time Frame

Up to 52 weeks

Title

Change of grip strength from baseline to Week 52

Time Frame

Up to 52 weeks

Title

Change of time in the 5-time chair stand test from baseline to Week 52

Time Frame

Up to 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Meitetsu Hospital

City

Aichi, Nagoya

ZIP/Postal Code

451-8511

Country

Japan

Facility Name

Chubu Rosai Hospital

City

Aichi, Nagoya

ZIP/Postal Code

455-8530

Country

Japan

Facility Name

Daido Hospital

City

Aichi, Nagoya

ZIP/Postal Code

457-8511

Country

Japan

Facility Name

Seino Internal Medicine Clinic

City

Fukushima, Koriyama

ZIP/Postal Code

963-8851

Country

Japan

Facility Name

Gifu University Hospital

City

Gifu, Gifu

ZIP/Postal Code

501-1194

Country

Japan

Facility Name

Watanabe Clinic

City

Hyogo, Nishinomiya

ZIP/Postal Code

662-0971

Country

Japan

Facility Name

Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

City

Kanagawa, Yokohama

ZIP/Postal Code

231-0023

Country

Japan

Facility Name

Medical Corporation KEISEIKAI Kajiyama clinic

City

Kyoto, Kyoto

ZIP/Postal Code

600-8898

Country

Japan

Facility Name

Medical Corporation Hayashi Katagihara Clinic

City

Kyoto, Kyoto

ZIP/Postal Code

615-8125

Country

Japan

Facility Name

Iryouhouijneiwakai Minamiakatsuka clinic

City

Mito, Ibaraki

ZIP/Postal Code

311-4153

Country

Japan

Facility Name

Moriya Keiyu Hospital

City

Moriya, Ibaraki

ZIP/Postal Code

302-0118

Country

Japan

Facility Name

North Alps Medical Center Azumi Hospital

City

Nagano, Kitaazumi-gun

ZIP/Postal Code

399-8695

Country

Japan

Facility Name

Asama Nanroku Komoro Medical Center

City

Nagano, Komoro

ZIP/Postal Code

384-8588

Country

Japan

Facility Name

Koshigaya Municipal Hospital

City

Saitama, Koshigaya

ZIP/Postal Code

343-8577

Country

Japan

Facility Name

Dojinkinenkai Meiwa Hospital

City

Tokyo, Chiyoda-ku

ZIP/Postal Code

101-0041

Country

Japan

Facility Name

Tokyo Asbo Clinic

City

Tokyo, Chuo-ku

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Shinagawa East one Medical Clinic

City

Tokyo, Minato-ku

ZIP/Postal Code

108-0075

Country

Japan

Facility Name

Ikebukuro Metropolitan Clinic

City

Tokyo, Toshima-ku

ZIP/Postal Code

171-0021

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing 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'

IPD Sharing URL

https://www.mystudywindow.com/msw/datasharing

Citations:

PubMed Identifier

33827843

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.

Results Reference

derived

Links:

URL

http://www.mystudywindow.com

Description

Related Info

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

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