A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Esgliteo (Empagliflozin/Linagliptin, 10/5mg, 25/5mg) in Korean Patients With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1,053
- Locations
- 30
- Primary Endpoint
- All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO®
Study Overview
Brief Summary
The objectives of this study are to monitor the safety and effectiveness of Esgliteo in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who have started at first time on Esgliteo in accordance with the approved label in Korea
- •Age ≥19 years at enrolment
- •Patients who have signed on the data release consent form
Exclusion Criteria
- •Patients with previous exposure to Esgliteo
- •Patients with hypersensitivity to the empagliflozin and/or linagliptin or any of the excipients
- •Patients with type 1 diabetes or diabetic ketoacidosis
- •Patients with estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/1.73m2, end stage renal disease, or patient on dialysis
- •Patients for whom empagliflozin/linagliptin is contraindicated according to the local label of Esgliteo
Arms & Interventions
Patients diagnosed with type 2 diabetes mellitus
Patients aged 19 years or older, diagnosed with type 2 diabetes mellitus in Korea, who initiated treatment with ESGLITEO® for the first time in accordance with the locally approved label.
Intervention: Empagliflozin/Linagliptin (Drug)
Outcomes
Primary Outcomes
All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO®
Time Frame: From first trial drug administration up to 24 weeks.
These include those who signed the data release consent form to participate in this study as subject, took Esgliteo once at least, and were followed up by the physician once or more.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment
Time Frame: From the first trial drug administration up to 24 weeks.
The mean change from baseline in glycosylated hemoglobin (HbA1c) after 24 weeks of treatment is presented.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 12 Weeks of Treatment
Time Frame: From the first trial drug administration up to 12 weeks.
The mean change from baseline in glycosylated hemoglobin (HbA1c) after 12 weeks of treatment is presented.
Secondary Outcomes
- Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment(From the first trial drug administration up to 12 weeks.)
- Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 24 Weeks of Treatment(From the first trial drug administration up to 24 weeks.)
- Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 12 Weeks of Treatment(From the first trial drug administration up to 12 weeks.)
- Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 24 Weeks of Treatment(From the first trial drug administration up to 24 weeks.)
- Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 12 Weeks of Treatment(From the first trial drug administration up to 12 weeks.)
- Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment(From the first trial drug administration up to 12 weeks.)
- Change From Baseline in Body Weight After 24 Weeks of Treatment(From the first trial drug administration up to 24 weeks.)
- Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment(From the first trial drug administration up to 24 weeks.)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment(From the first trial drug administration up to 24 weeks.)
- Change From Baseline in Body Weight After 12 Weeks of Treatment(From the first trial drug administration up to 12 weeks.)