JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848833
• Other study ID #: 1245.116
• Status: Completed
• Start date: August 10, 2016
• Est. completion date: April 17, 2020

Study information

• Verified date: April 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3368
• Est. completion date: April 17, 2020
• Est. primary completion date: April 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 110 Years

Eligibility

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®

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• JARDIANCE 10mg
T2DM with JARDIANCE 10mg
• JARDIANCE 25mg
MT2DM with JARDIANCE 25mgax

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).

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