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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JARDIANCE® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JARDIANCE® | Drug | JARDIANCE® |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Adverse Drug Reactions (ADRs) | ADRs were defined as those adverse events for which the causal relationship was considered "Possibility high " or "Possibility low" or "Unknown" by the principal investigator, where:
| From first drug administration until 7 days after last drug adminstration, up to 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period | Change from baseline in HbA1c (%) at the last observation during the observation period is reported. Change from baseline was calculated as: HbA1c value at the last observation - HbA1c baseline value. | Baseline and last observation on treatment, up to week 52. |
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Inclusion criteria:
Male and female elderly patients (age 65 and over) with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment and start taking JARDIANCE® Tablets within 3 months after launch in Japan
Exclusion criteria:
None
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All patients start taking JARDIANCE® Tablets within 3 months after launch will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NISND Center | Multiple Locations | Japan |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the 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".
Furthermore, researchers can 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.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
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 the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
All subjects were screened for eligibility prior to participation in the study. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
This Post-Marketing-Surveillance was a prospective study using a continuous investigation system. Patients with type 2 diabetes mellitus were included in the surveillance.
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| ID | Title | Description |
|---|---|---|
| FG000 | JARDIANCE® | Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Set : This analysis set included all elderly patients who had received treatment of JARDIANCE® Tablet at least one time except those who were found to have no observation after enrolment.
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| ID | Title | Description |
|---|---|---|
| BG000 | JARDIANCE® | Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Patients With Adverse Drug Reactions (ADRs) | ADRs were defined as those adverse events for which the causal relationship was considered "Possibility high " or "Possibility low" or "Unknown" by the principal investigator, where:
| Safety set: This analysis set included all elderly patients who had received treatment of JARDIANCE® Tablet at least one time except those who were found to have no observation after enrolment. | Posted | Number | Percentage of participants | From first drug administration until 7 days after last drug adminstration, up to 52 weeks. |
|
From first drug administration until 7 days after last drug adminstration, up to 52 weeks
Safety Set: This analysis set included all elderly patients who had received treatment of JARDIANCE® Tablet at least one time except those who were found to have no observation after enrolment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JARDIANCE® | Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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The study was conducted in an unblinded manner and without controls. The sample size was not sufficient for rare ADRs. Some priority survey items were not reported, therefore incidence could not be estimated
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period | Change from baseline in fasting plasma glucose (FPG) at the last observation during the observation period. Change from baseline was calculated as: FPG value at the last observation - FPG baseline value. | Baseline and last observation on treatment, up to week 52. |
| Improvement/remission |
|
| No change/progressive disease |
|
| Other than stated above |
|
| Not treated |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Elderly (age 65 and over) patients with type 2 diabetes mellitus who had never received JARDIANCE® Tablets were administered JARDIANCE® Tablets within 3 months after launch in Japan. Patients were administered orally with the starting at lower dosages (10 mg) of JARDIANCE®. In patients tolerating JARDIANCE, the dose was increased to 25 mg. |
|
|
| Secondary | Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period | Change from baseline in HbA1c (%) at the last observation during the observation period is reported. Change from baseline was calculated as: HbA1c value at the last observation - HbA1c baseline value. | Efficacy Set: This analysis set was a subset of the safety set, which included all patients in the "safety set" except those who had no available efficacy data for this outcome measure. | Posted | Mean | Standard Deviation | percentage of haemoglobin A1c | Baseline and last observation on treatment, up to week 52. |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period | Change from baseline in fasting plasma glucose (FPG) at the last observation during the observation period. Change from baseline was calculated as: FPG value at the last observation - FPG baseline value. | Efficacy set: This analysis set was a subset of the safety set, which included all patients in the "safety set" except those who had no available efficacy data for this outcome measure. | Posted | Mean | Standard Deviation | milligram/deciliter (mg/dL) | Baseline and last observation on treatment, up to week 52. |
|
|
|
| 1 |
| 414 |
| 6 |
| 414 |
| 0 |
| 414 |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Age-related macular degeneration | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |