Diabetes Mellitus, Type 2
Conditions
Brief summary
Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
Interventions
DRUGJARDIANCE®
JARDIANCE®
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Adverse Drug Reactions (ADRs) | From first drug administration until 7 days after last drug adminstration, up to 52 weeks. | 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: * Possibility high: There is a reasonable causal relationship between JARDIANCE® tablets administered and the adverse events (AE); * Possibility low: It is probably/possibly that there is a reasonable causal relationship between JARDIANCE® tablets administered and the AE; * Unknown: Cannot be judged because information is insufficient or contradictory. Percentages were rounded to two decimal places. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period | Baseline and last observation on treatment, up to week 52. | 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. |
| Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period | Baseline and last observation on treatment, up to week 52. | 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. |
Countries
Japan
Participant flow
Recruitment details
This Post-Marketing-Surveillance was a prospective study using a continuous investigation system. Patients with type 2 diabetes mellitus were included in the surveillance.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 414 |
| Total | 414 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 64 |
| Overall Study | Improvement/remission | 2 |
| Overall Study | No change/progressive disease | 78 |
| Overall Study | Not treated | 2 |
| Overall Study | No visit since the first visit | 3 |
| Overall Study | Other than stated above | 20 |
| Overall Study | Request by patient | 53 |
Baseline characteristics
| Characteristic | JARDIANCE® |
|---|---|
| Age, Continuous | 71.8 Years STANDARD_DEVIATION 5.5 |
| Sex: Female, Male Female | 170 Participants |
| Sex: Female, Male Male | 244 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 414 |
| other Total, other adverse events | 0 / 414 |
| serious Total, serious adverse events | 6 / 414 |
Outcome results
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: * Possibility high: There is a reasonable causal relationship between JARDIANCE® tablets administered and the adverse events (AE); * Possibility low: It is probably/possibly that there is a reasonable causal relationship between JARDIANCE® tablets administered and the AE; * Unknown: Cannot be judged because information is insufficient or contradictory. Percentages were rounded to two decimal places.
Time frame: From first drug administration until 7 days after last drug adminstration, up to 52 weeks.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JARDIANCE® | Percentage of Patients With Adverse Drug Reactions (ADRs) | 20.53 Percentage of participants |
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.
Time frame: Baseline and last observation on treatment, up to week 52.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JARDIANCE® | Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period | -8.4 milligram/deciliter (mg/dL) | Standard Deviation 45.6 |
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.
Time frame: Baseline and last observation on treatment, up to week 52.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JARDIANCE® | Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period | -0.36 percentage of haemoglobin A1c | Standard Deviation 1.03 |