A Phase 4 interventional study of Empagliflozin and Placebo in Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim. Completed at 18 sites in Japan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment
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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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
Exclusion Criteria:
Drug: Empagliflozin
Drug: Placebo
Empagliflozin
Placebo
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.
Time frame: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and at Week 52.
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.
| Milestone | Placebo | Empagliflozin 10 mg |
|---|---|---|
| Started | 64 | 65 |
| Completed | 58 | 61 |
| Not completed | 6 | 4 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Adverse event | 3 | 3 |
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.
| percentage of glycated hemoglobin | Placebo | Empagliflozin 10 mg |
|---|---|---|
| Change in HbA1c From Baseline After 52 Weeks of Treatment | -0.12 ± 0.08 | -0.69 ± 0.07 |
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.
| kilogram | Placebo | Empagliflozin 10 mg |
|---|---|---|
| Change of Muscle Mass From Baseline to Week 52 | -0.96 ± 0.36 | -1.57 ± 0.35 |
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.
| kilogram | Placebo | Empagliflozin 10 mg |
|---|---|---|
| Change of Body Fat Measurement From Baseline to Week 52 | 0.08 ± 0.29 | -1.77 ± 0.28 |
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.
| kilogram | Placebo | Empagliflozin 10 mg |
|---|---|---|
| Change of Lean Body Mass From Baseline to Week 52 | -1.08 ± 0.27 | -1.61 ± 0.26 |
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.
| kilogram | Placebo | Empagliflozin 10 mg |
|---|---|---|
| Change of Total Body Water From Baseline to Week 52 | -0.72 ± 0.21 | -1.35 ± 0.21 |
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.
| kilogram | Placebo | Empagliflozin 10 mg |
|---|---|---|
| Change of Bone Mineral Content From Baseline to Week 52 | -0.06 ± 0.02 | -0.09 ± 0.01 |
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.
| kilogram/meter^2 (kg/m^2) | Placebo | Empagliflozin 10 mg |
|---|---|---|
| Change of Skeletal Muscle Index From Baseline to Week 52 | -0.245 ± 0.064 | -0.326 ± 0.062 |
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.
| kilogram | Placebo | Empagliflozin 10 mg |
|---|---|---|
| Change of Grip Strength From Baseline to Week 52 | -0.6 ± 0.3 | -0.9 ± 0.3 |
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.
| seconds | Placebo | Empagliflozin 10 mg |
|---|---|---|
| Change of Time in the 5-time Chair Stand Test From Baseline to Week 52 | -0.9 ± 0.3 | -0.9 ± 0.3 |
Collected over From the administration of first dose of randomised trial medication until treatment stop +7 days of residual effect period, up to 378 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 1/64 (1.6%) | 8/64 (12.5%) | 13/64 (20.3%) |
| Empagliflozin 10mg | 0/65 (0%) | 8/65 (12.3%) | 14/65 (21.5%) |
| Event | Placebo | Empagliflozin 10mg |
|---|---|---|
| Femoral neck fractureInjury, poisoning and procedural complications | 2/64 | 0/65 |
| CataractEye disorders | 1/64 | 1/65 |
| DeathGeneral disorders | 1/64 | 0/65 |
| Brain contusionInjury, poisoning and procedural complications | 1/64 | 0/65 |
| Rib fractureInjury, poisoning and procedural complications | 1/64 | 0/65 |
| Traumatic haemothoraxInjury, poisoning and procedural complications | 1/64 | 0/65 |
| Facial paralysisNervous system disorders | 1/64 | 0/65 |
| Optic neuritisNervous system disorders | 1/64 | 0/65 |
| Atrial fibrillationCardiac disorders | 0/64 | 1/65 |
| Exfoliation glaucomaEye disorders | 0/64 | 1/65 |
| Event | Placebo | Empagliflozin 10mg |
|---|---|---|
| ConstipationGastrointestinal disorders | 3/64 | 7/65 |
| DiarrhoeaGastrointestinal disorders | 4/64 | 0/65 |
| NasopharyngitisInfections and infestations | 4/64 | 3/65 |
| PyrexiaGeneral disorders | 3/64 | 4/65 |
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.
| Age, Continuous(years) | Placebo | Empagliflozin 10 mg | Total |
|---|---|---|---|
| Mean | 74.0 ± 5.1 | 74.2 ± 4.9 | 74.1 ± 5.0 |
| Sex: Female, Male(Participants) | Placebo | Empagliflozin 10 mg | Total |
|---|---|---|---|
| Female | 19 | 16 | 35 |
| Male | 44 | 48 | 92 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Empagliflozin 10 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 63 | 64 | 127 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | Empagliflozin 10 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 63 | 64 | 127 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Percentage of glycated haemoglobin (HbA1c)(Percentage of glycated haemoglobin) | Placebo | Empagliflozin 10 mg | Total |
|---|---|---|---|
| Mean | 7.6 ± 0.5 | 7.6 ± 0.5 | 7.6 ± 0.5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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 information: Study protocol, Sap, Csr
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