NCT02367131

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

Completed Results posted Last updated 8 March 2024

What this trial tests

trial testing JARDIANCE® in Diabetes Mellitus, Type 2 in 419 participants. Completed in 27 September 2016.

Timeline

24 February 2015

Primary endpoint
27 September 2016

27 September 2016

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	419
Start date	24 February 2015
Primary completion	27 September 2016
Estimated completion	27 September 2016
Sites	1 location across Japan

Drugs / interventions tested

• JARDIANCE®

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

65 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients With Adverse Drug Reactions (ADRs) Primary · 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.

Group	Value	95% CI
JARDIANCE®	20.53

Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period Secondary · 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.

Group	Value	95% CI
JARDIANCE®	-0.36	± 1.03

Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period Secondary · 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.

Group	Value	95% CI
JARDIANCE®	-8.4	± 45.6

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug administration until 7 days after last drug adminstration, up to 52 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

JARDIANCE®

Serious: 6/414 (1%)

Deaths: 1/414

Serious adverse events (6 terms)

Reaction	System	JARDIANCE®
Atrial flutter	Cardiac disorders	—
Stress cardiomyopathy	Cardiac disorders	—
Age-related macular degeneration	Eye disorders	—
Hepatic cirrhosis	Hepatobiliary disorders	—
Pneumonia	Infections and infestations	—
Blood glucose increased	Investigations	—

Most-reported serious reactions: Atrial flutter, Stress cardiomyopathy, Age-related macular degeneration, Hepatic cirrhosis, Pneumonia, Blood glucose increased.

Data from ClinicalTrials.gov NCT02367131 adverse events section.

Sponsor's own description

Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The role of empagliflozin in the management of type 2 diabetes by patient profile.
   Hedrington MS, Davis SN. · · 2015 · cited 6× · PMID 25999725 · DOI 10.2147/tcrm.s71762