JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus
- Registration Number
- NCT02848833
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3368
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description JARDIANCE JARDIANCE 25mg T2DM with JARDIANCE JARDIANCE JARDIANCE 10mg T2DM with JARDIANCE
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events Relating to Study Drug 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 was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug 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 was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Percentage of Participants With Any Adverse Events 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 any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Percentage of Participants With Unexpected Adverse Events 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 was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Percentage of Participants With Adverse Events of Special Interest 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 (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
- Secondary Outcome Measures
Name Time Method 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). Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the 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). Change from baseline in glycosylated hemoglobin (HbA1c) 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 body weight 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 fasting plasma glucose (FPG) 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). Change from baseline in diastolic blood pressure (DBP) at last visit.
Number of Participants Per Final Effectiveness Assessment Category at Last Visit 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 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.).
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 who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the 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 systolic blood pressure (SBP) at last visit.