Trial Outcomes & Findings for Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus (NCT NCT02367131)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

419 participants

Primary outcome timeframe

From first drug administration until 7 days after last drug adminstration, up to 52 weeks.

Results posted on

2024-03-08

Participant Flow

This Post-Marketing-Surveillance was a prospective study using a continuous investigation system. Patients with type 2 diabetes mellitus were included in the surveillance.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	419
Overall Study Treated	417
Overall Study COMPLETED	197
Overall Study NOT COMPLETED	222

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	64
Overall Study No visit since the first visit	3
Overall Study Request by patient	53
Overall Study Improvement/remission	2
Overall Study No change/progressive disease	78
Overall Study Other than stated above	20
Overall Study Not treated	2

Baseline Characteristics

Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JARDIANCE® n=414 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.
Age, Continuous	71.8 Years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	170 Participants n=5 Participants
Sex: Female, Male Male	244 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	JARDIANCE® n=414 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.
Percentage of Patients With Adverse Drug Reactions (ADRs)	20.53 Percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	JARDIANCE® n=385 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.
Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period	-0.36 percentage of haemoglobin A1c Standard Deviation 1.03

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	JARDIANCE® n=240 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.
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

Adverse Events

JARDIANCE®

Serious events: 6 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	JARDIANCE® n=414 participants at risk 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.
Cardiac disorders Atrial flutter	0.24% 1/414 • 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.
Cardiac disorders Stress cardiomyopathy	0.24% 1/414 • 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.
Eye disorders Age-related macular degeneration	0.24% 1/414 • 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.
Hepatobiliary disorders Hepatic cirrhosis	0.24% 1/414 • 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.
Infections and infestations Pneumonia	0.24% 1/414 • 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.
Investigations Blood glucose increased	0.24% 1/414 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place