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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin 10 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Empagliflozin |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Muscle Mass From Baseline to Week 52 | Muscle mass was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition, and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of muscle mass from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline muscle mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. |
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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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meitetsu Hospital | Aichi, Nagoya | 451-8511 | Japan | |||
| Chubu Rosai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33827843 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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.
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'
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This randomised, double-blind, placebo-controlled, parallel group, multicentre trial compared 10 mg empagliflozin with placebo after 52 weeks in elderly Japanese patients with Type 2 diabetes mellitus (T2DM) and insufficient glycaemic control.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet of placebo matching empagliflozin in addition to the standard of care treatment |
| FG001 | Empagliflozin 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2020 | Jul 21, 2023 |
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| Drug |
Placebo |
|
| At baseline and at Week 52 |
| Change of Body Fat Measurement From Baseline to Week 52 | Body fat mass was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of body fat measurement from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline body fat measurement, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | At baseline and at Week 52 |
| Change of Lean Body Mass From Baseline to Week 52 | Lean body mass (fat-free mass) was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition, and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of lean body mass from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline lean body mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | At baseline and at Week 52. |
| Change of Total Body Water From Baseline to Week 52 | Total body water was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition, and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of total body water from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline total body water, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | At baseline and at Week 52. |
| Change of Bone Mineral Content From Baseline to Week 52 | Bone mineral content (estimated bone mass) was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition, and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of bone mineral content from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline bone mineral content, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | At baseline and at Week 52. |
| Change of Skeletal Muscle Index From Baseline to Week 52 | Skeletal muscle index is calculated by dividing the limb muscle mass (kg) by the square of the height (m2). The limb muscle mass was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition, and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of skeletal muscle index from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline skeletal muscle index, age, baseline glycated hemoglobin (HbA1c), baseline body mass index as linear covariates and sex, treatment as fixed effects. "Baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | At baseline and at Week 52. |
| Change of Grip Strength From Baseline to Week 52 | A Smedley-type dynamometer was used to measure grip strength. The site staff instructed the patient to adjust the grip width so that the second joint of the index finger is approximately 90 degrees (almost right angle). The site staff asked the patient to be careful not to touch the body or clothes with hand while keeping arms down naturally. The site staff made sure that the patient does not wave the grip dynamometer. Grip strength was measured twice alternately left and right. Change of grip strength from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline grip strength, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | At baseline and at Week 52. |
| Change of Time in the 5-time Chair Stand Test From Baseline to Week 52 | For the stand test patients fold their arms across their chest and try to stand up once from a chair. If patients can stand from a chair, they repeat same action five times. It is measured the time required to perform five rise from a chair to an upright position as fast as possible without the use of arms. Change of time in the 5-time chair stand test from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline 5-time chair stand test, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | At baseline and at Week 52. |
| Aichi, Nagoya |
| 455-8530 |
| Japan |
| Daido Hospital | Aichi, Nagoya | 457-8511 | Japan |
| Seino Internal Medicine Clinic | Fukushima, Koriyama | 963-8851 | Japan |
| Gifu University Hospital | Gifu, Gifu | 501-1194 | Japan |
| Watanabe Clinic | Hyogo, Nishinomiya | 662-0971 | Japan |
| Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic | Kanagawa, Yokohama | 231-0023 | Japan |
| Medical Corporation KEISEIKAI Kajiyama Clinic | Kyoto, Kyoto | 600-8898 | Japan |
| Medical Corporation Hayashi Katagihara Clinic | Kyoto, Kyoto | 615-8125 | Japan |
| Iryouhouijneiwakai Minamiakatsuka Clinic | Mito, Ibaraki | 311-4153 | Japan |
| Moriya Keiyu Hospital | Moriya, Ibaraki | 302-0118 | Japan |
| North Alps Medical Center Azumi Hospital | Nagano, Kitaazumi-gun | 399-8695 | Japan |
| Asama Nanroku Komoro Medical Center | Nagano, Komoro | 384-8588 | Japan |
| Koshigaya Municipal Hospital | Saitama, Koshigaya | 343-8577 | Japan |
| Dojinkinenkai Meiwa Hospital | Tokyo, Chiyoda-ku | 101-0041 | Japan |
| Tokyo Asbo Clinic | Tokyo, Chuo-ku | 104-0031 | Japan |
| Shinagawa East one Medical Clinic | Tokyo, Minato-ku | 108-0075 | Japan |
| Ikebukuro Metropolitan Clinic | Tokyo, Toshima-ku | 171-0021 | Japan |
Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): This set included all patients randomised, treated with at least one dose of trial medication, and with a baseline and at least one on-treatment glycated haemoglobin (HbA1c) value.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet of placebo matching empagliflozin in addition to the standard of care treatment |
| BG001 | Empagliflozin 10 mg | Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Percentage of glycated haemoglobin (HbA1c) | Percentage of glycated haemoglobin (HbA1c) at baseline. | Mean | Standard Deviation | Percentage of glycated haemoglobin |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set (Observed cases): This set included all patients randomised, treated with at least one dose of trial medication, and with a baseline and at least one on-treatment HbA1c value. Only the available data that were observed while the patients were on treatment were analysed. | Posted | Least Squares Mean | Standard Error | percentage of glycated hemoglobin | 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. |
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| Secondary | Change of Muscle Mass From Baseline to Week 52 | Muscle mass was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition, and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of muscle mass from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline muscle mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | Treated set (Observed cases, including values after rescue (OC-IR)): All patients randomized and treated with at least one dose of trial medication. Values measured after rescue medication were also used. Patients with missing values at Week 52 or at baseline were not included in the analysis. | Posted | Least Squares Mean | Standard Error | kilogram | At baseline and at Week 52 |
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| Secondary | Change of Body Fat Measurement From Baseline to Week 52 | Body fat mass was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of body fat measurement from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline body fat measurement, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | Treated set (Observed cases, including values after rescue (OC-IR)): All patients randomized and treated with at least one dose of trial medication. Values measured after rescue medication were also used. Patients with missing values at Week 52 or at baseline were not included in the analysis. | Posted | Least Squares Mean | Standard Error | kilogram | At baseline and at Week 52 |
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| Secondary | Change of Lean Body Mass From Baseline to Week 52 | Lean body mass (fat-free mass) was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition, and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of lean body mass from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline lean body mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | Treated set (Observed cases, including values after rescue (OC-IR)): All patients randomized and treated with at least one dose of trial medication. Values measured after rescue medication were also used. Patients with missing values at Week 52 or at baseline were not included in the analysis. | Posted | Least Squares Mean | Standard Error | kilogram | At baseline and at Week 52. |
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| Secondary | Change of Total Body Water From Baseline to Week 52 | Total body water was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition, and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of total body water from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline total body water, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | Treated set (Observed cases, including values after rescue (OC-IR)): All patients randomized and treated with at least one dose of trial medication. Values measured after rescue medication were also used. Patients with missing values at Week 52 or at baseline were not included in the analysis. | Posted | Least Squares Mean | Standard Error | kilogram | At baseline and at Week 52. |
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| Secondary | Change of Bone Mineral Content From Baseline to Week 52 | Bone mineral content (estimated bone mass) was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition, and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of bone mineral content from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline bone mineral content, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | Treated set (Observed cases, including values after rescue (OC-IR)): All patients randomized and treated with at least one dose of trial medication. Values measured after rescue medication were also used. Patients with missing values at Week 52 or at baseline were not included in the analysis. | Posted | Least Squares Mean | Standard Error | kilogram | At baseline and at Week 52. |
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| Secondary | Change of Skeletal Muscle Index From Baseline to Week 52 | Skeletal muscle index is calculated by dividing the limb muscle mass (kg) by the square of the height (m2). The limb muscle mass was estimated via bioelectrical impedance analysis (BIA) which is a commonly used method for estimating body composition, and it assesses body composition by passing a very small current through the body and assessing differences in impedance caused by the fact that fat and lean tissues have different electrical properties. To measure the body composition the patient barefoot stood on the bench evenly on the toe and heel electrodes and held the grip on each hand. Change of skeletal muscle index from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline skeletal muscle index, age, baseline glycated hemoglobin (HbA1c), baseline body mass index as linear covariates and sex, treatment as fixed effects. "Baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | Treated set (Observed cases, including values after rescue (OC-IR)): All patients randomized and treated with at least one dose of trial medication. Values measured after rescue medication were also used. Patients with missing values at Week 52 or at baseline were not included in the analysis. | Posted | Least Squares Mean | Standard Error | kilogram/meter^2 (kg/m^2) | At baseline and at Week 52. |
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| Secondary | Change of Grip Strength From Baseline to Week 52 | A Smedley-type dynamometer was used to measure grip strength. The site staff instructed the patient to adjust the grip width so that the second joint of the index finger is approximately 90 degrees (almost right angle). The site staff asked the patient to be careful not to touch the body or clothes with hand while keeping arms down naturally. The site staff made sure that the patient does not wave the grip dynamometer. Grip strength was measured twice alternately left and right. Change of grip strength from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline grip strength, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | Treated set (Observed cases, including values after rescue (OC-IR)): All patients randomized and treated with at least one dose of trial medication. Values measured after rescue medication were also used. Patients with missing values at Week 52 or at baseline were not included in the analysis. | Posted | Least Squares Mean | Standard Error | kilogram | At baseline and at Week 52. |
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| Secondary | Change of Time in the 5-time Chair Stand Test From Baseline to Week 52 | For the stand test patients fold their arms across their chest and try to stand up once from a chair. If patients can stand from a chair, they repeat same action five times. It is measured the time required to perform five rise from a chair to an upright position as fast as possible without the use of arms. Change of time in the 5-time chair stand test from baseline to Week 52 was modelled using an Analysis of Covariance (ANCOVA) which included baseline 5-time chair stand test, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects. The term "baseline" refers to the last observed measurement prior to the administration of any randomised trial medication. | Treated set (Observed cases, including values after rescue (OC-IR)): All patients randomized and treated with at least one dose of trial medication. Values measured after rescue medication were also used. Patients with missing values at Week 52 or at baseline were not included in the analysis. | Posted | Least Squares Mean | Standard Error | seconds | At baseline and at Week 52. |
|
From the administration of first dose of randomised trial medication until treatment stop +7 days of residual effect period, up to 378 days.
Treated set: All patients randomized and treated with at least one dose of trial medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet of placebo matching empagliflozin in addition to the standard of care treatment | 1 | 64 | 8 | 64 | 13 | 64 |
| EG001 | Empagliflozin 10mg | Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment. | 0 | 65 | 8 | 65 | 14 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Exfoliation glaucoma | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Duodenal polyp | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Traumatic haemothorax | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2022 | Jul 21, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
Null hypothesis: Mean change from baseline in HbA1c after 52 weeks of treatment with empagliflozin 10 mg = mean change from baseline in HbA1c after 52 weeks of treatment with placebo. |
Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment. |
|
|
|
| Empagliflozin 10 mg |
Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment. |
|
|
|
| Empagliflozin 10 mg |
Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment. |
|
|
|
| Empagliflozin 10 mg |
Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment. |
|
|
|
| Empagliflozin 10 mg |
Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment. |
|
|
|
| OG001 | Empagliflozin 10 mg | Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment. |
|
|
|
Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment. |
|
|
|
Type 2 diabetes mellitus (T2DM) Japanese patients older than 65 years administered orally once daily one film-coated tablet 10 milligram (mg) of empagliflozin in addition to the standard of care treatment.
|
|
|