JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of JARDIANCE® (Empagliflozin, 10mg, 25mg, q.d.) in Korean Patients With Type 2 Diabetes Mellitus

To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: JARDIANCE 10mg; Drug: JARDIANCE 25mg

• Study Type: Observational
• Enrollment (Actual): 3368

Contacts and Locations

Study Locations

• Korea, Republic of
  • Multiple Locations, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 110 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

type 2 diabetes mellitus in Korea

Description

Inclusion criteria:

1. Patients who have been started on JARDIANCE® in accordance with the approved label in Korea
2. Age = 19 years at enrolment
3. Patients who have signed on the data release consent form

Exclusion criteria:

1. Known hypersensitivity to empagliflozin or any of its excipients
2. Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis
3. Patients with persistent estimated Glomerular Filtration Rate <60 mL/min/1.73 m2,end stage renal disease or on dialysis
4. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
5. Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
JARDIANCE; T2DM with JARDIANCE	Drug: JARDIANCE 10mg; T2DM with JARDIANCE 10mg; Drug: JARDIANCE 25mg; MT2DM with JARDIANCE 25mgax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Any Adverse Events	Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of Participants With Adverse Events Relating to Study Drug	Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of Participants With Unexpected Adverse Events	Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of Participants With Adverse Events of Special Interest	Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. The following are considered as AESIs: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection; Increased urination; Urinary tract infection (UTI); Volume depletion; Diabetic Ketoacidosis (DKA); Decreased renal function:; Hepatic injury; Lower limb amputation	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug	Percentage of participants with adverse events leading to discontinuation of the drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit	Change from baseline in glycosylated hemoglobin (HbA1c) at last visit.	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit	Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit.	At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit	Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit	Change from baseline in fasting plasma glucose (FPG) at last visit.	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Body Weight at Last Visit	Change from baseline in body weight at last visit.	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit	Change from baseline in systolic blood pressure (SBP) at last visit.	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit	Change from baseline in diastolic blood pressure (DBP) at last visit.	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Number of Participants Per Final Effectiveness Assessment Category at Last Visit	Number of participants per final effectiveness assessment category at last visit was reported. The final effeciveness consisted of 4 categories: Improved (If determined as there was any effect of maintaining or improving disease related factors.), Unchanged (If disease related factors had not been changed compared with before administration, and not determined as there was any effect of maintaining symptoms.), Aggravated (If disease related factors were worse than before administration.), and Unassessable (If it cannot be determined due to insufficient information collected.).	At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2016
• Primary Completion (ACTUAL): April 17, 2020
• Study Completion (ACTUAL): April 17, 2020

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (ESTIMATE): July 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 1245.116