Clinical trial NCT02848833: JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 3368
Sex: ALL
Minimum age (years): 19
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: type 2 diabetes mellitus in Korea

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


Eligibility criteria: 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®

Primary outcomes:
measure: Percentage of Participants With Any Adverse Events
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
measure: Percentage of Participants With Adverse Events Relating to Study Drug
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
measure: Percentage of Participants With Unexpected Adverse Events
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
measure: Percentage of Participants With Adverse Events of Special Interest
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
measure: Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug
timeFrame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit
timeFrame: 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).
measure: Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit
timeFrame: At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
measure: Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit
timeFrame: 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).
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit
timeFrame: 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).
measure: Change From Baseline in Body Weight at Last Visit
timeFrame: 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).
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit
timeFrame: 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).
measure: Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit
timeFrame: 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).
measure: Number of Participants Per Final Effectiveness Assessment Category at Last Visit
timeFrame: At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: