Diabetes Mellitus, Type 2
Conditions
Brief summary
Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus
Interventions
DRUGJardiance
Empagliflozin
Sponsors
Eli Lilly and Company
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Drug Reactions (ADRs) | From first drug administration until 7 days after last drug administration, up to 247 weeks. | Number of patients with adverse drug reactions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period | At start of treatment and at last observation on treatment, up to 246 weeks. | Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period | At start of treatment and at last observation on treatment, up to 246 weeks. | Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period. |
Countries
Japan
Participant flow
Recruitment details
A non-interventional study to investigate the safety and efficacy of longterm daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus.
Pre-assignment details
Non-randomized, post marketing surveillance, a prospective study using a continuous investigation system. No specific criteria (e.g. demographic, baseline concomitant drug in use) were defined for participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| JARDIANCE® User 10 Milligram (mg) or 25 mg Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks. | 7,947 |
| Total | 7,947 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 522 |
| Overall Study | Improvement/remission | 157 |
| Overall Study | Lost to Follow-up | 456 |
| Overall Study | Multiple registration | 1 |
| Overall Study | No change/Progressive disease | 263 |
| Overall Study | No CRF collected | 86 |
| Overall Study | No patient visit after entry | 100 |
| Overall Study | Not continuously investigated | 7 |
| Overall Study | No treatment with Jardiance | 2 |
| Overall Study | Other personal reasons | 1,218 |
| Overall Study | Patient received Jardiance before registration | 1 |
| Overall Study | Patient started jardiance treatment out of registration period | 1 |
| Overall Study | Request by patient | 602 |
Baseline characteristics
| Characteristic | JARDIANCE® User 10 Milligram (mg) or 25 mg | — |
|---|---|---|
| Age, Continuous | 58.8 Years STANDARD_DEVIATION 12.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2939 Participants | — |
| Sex: Female, Male Male | 5008 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 42 / 7,947 |
| other Total, other adverse events | 0 / 7,947 |
| serious Total, serious adverse events | 381 / 7,947 |
Outcome results
Primary
Number of Patients With Adverse Drug Reactions (ADRs)
Number of patients with adverse drug reactions.
Time frame: From first drug administration until 7 days after last drug administration, up to 247 weeks.
Population: Safety Set: All patients who had received treatment of JARDIANCE® tablet at least one time except those who were found to have no observation after enrollment, invalid registration, or invalid contract with the site.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JARDIANCE® User 10 Milligram (mg) or 25 mg | Number of Patients With Adverse Drug Reactions (ADRs) | 1029 Participants |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period
Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period.
Time frame: At start of treatment and at last observation on treatment, up to 246 weeks.
Population: All patients included in the efficacy set and with available data for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JARDIANCE® User 10 Milligram (mg) or 25 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period | -30.1 Milligram/deciliter (mg/dL) | Standard Deviation 55.5 |
Secondary
Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period
Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period.
Time frame: At start of treatment and at last observation on treatment, up to 246 weeks.
Population: Efficacy set: All patients in the safety set, except patients who had no available efficacy data and/or do not suffer from type 2 diabetes mellitus.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JARDIANCE® User 10 Milligram (mg) or 25 mg | Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period | -0.74 Percentage change | Standard Deviation 1.34 |