NCT02489942

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

Completed Results posted Last updated 4 February 2022

What this trial tests

trial testing Jardiance in Diabetes Mellitus, Type 2 in 8,145 participants. Completed in 4 December 2020.

Timeline

12 June 2015

Primary endpoint
11 November 2020

4 December 2020

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	8,145
Start date	12 June 2015
Primary completion	11 November 2020
Estimated completion	4 December 2020
Sites	1 location across Japan

Drugs / interventions tested

• Jardiance (empagliflozin) — full drug profile →

Conditions studied

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

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 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.

Number of Patients With Adverse Drug Reactions (ADRs) Primary · From first drug administration until 7 days after last drug administration, up to 247 weeks.

Number of patients with adverse drug reactions.

Group	Value	95% CI
JARDIANCE® User 10 Milligram (mg) or 25 mg	1029

Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period Secondary · 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.

Group	Value	95% CI
JARDIANCE® User 10 Milligram (mg) or 25 mg	-0.74	± 1.34

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

Group	Value	95% CI
JARDIANCE® User 10 Milligram (mg) or 25 mg	-30.1	± 55.5

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug administration until 7 days after last drug administration, up to 247 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

JARDIANCE® User 10 Milligram (mg) or 25 mg

Serious: 381/7947 (5%)

Deaths: 42/7947

Serious adverse events (311 terms)

Reaction	System	JARDIANCE® User 10 Milligr…
Metabolism and nutrition disorders	Investigations	—
Cerebral infarction	Nervous system disorders	—
Angina pectoris	Cardiac disorders	—
Acute myocardial infarction	Cardiac disorders	—
Fall	Injury, poisoning and procedural complications	—
Diabetes mellitus inadequate control	Investigations	—
Musculoskeletal and connective tissue disorders	Investigations	—
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Cellulitis	Infections and infestations	—
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Cardiac failure	Cardiac disorders	—
Myocardial infarction	Cardiac disorders	—
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Road traffic accident	Injury, poisoning and procedural complications	—
Hyperglycaemia	Investigations	—
Osteoarthritis	Investigations	—
Dementia	Nervous system disorders	—
Sudden death	General disorders	—
Pneumonia	Infections and infestations	—
Pyelonephritis	Infections and infestations	—
Subdural haematoma	Injury, poisoning and procedural complications	—
Diabetes mellitus	Investigations	—
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—
Anaemia	Blood and lymphatic system disorders	—

Most-reported serious reactions: Metabolism and nutrition disorders, Cerebral infarction, Angina pectoris, Acute myocardial infarction, Fall, Diabetes mellitus inadequate control, Musculoskeletal and connective tissue disorders, Lung neoplasm malignant.

Data from ClinicalTrials.gov NCT02489942 adverse events section.

Sponsor's own description

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

Publications & conference data

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

1. Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study.
   Kaku K, Chin R, Naito Y, Iliev H, et al · · 2020 · cited 20× · PMID 31769309 · DOI 10.1080/14740338.2020.1694659