Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus
- Registration Number
- NCT05130463
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1053
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients diagnosed with type 2 diabetes mellitus Empagliflozin/Linagliptin 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.
- Primary Outcome Measures
Name Time Method All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO® 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 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 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 Outcome Measures
Name Time Method Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment From the first trial drug administration up to 12 weeks. Change from baseline in fasting plasma glucose (FPG) of participants after 12 weeks of treatment is presented.
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. The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 24 weeks following trial drug administration are presented.
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. Mean change from baseline in blood pressure (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) of participants after 12 weeks of treatment is presented.
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. Mean change from baseline in blood pressure (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) of participants after 24 weeks of treatment is presented.
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. The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 12 weeks following trial drug administration are presented.
Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment From the first trial drug administration up to 12 weeks. Relative effectiveness was defined as participants whose HbA1c decreased by at least 0.5% (relative effectiveness response rate) at 12 weeks after administration of ESGLITEO®.
Change From Baseline in Body Weight After 24 Weeks of Treatment From the first trial drug administration up to 24 weeks. Change from baseline in body weight of participants after 24 weeks of treatment is presented.
Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment From the first trial drug administration up to 24 weeks. Relative effectiveness was defined as participants whose HbA1c decreased by at least 0.5% (relative effectiveness response rate) at 24 weeks after administration of ESGLITEO®.
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 fasting plasma glucose (FPG) of participants after 24 weeks of treatment is presented.
Change From Baseline in Body Weight After 12 Weeks of Treatment From the first trial drug administration up to 12 weeks. Change from baseline in body weight of participants after 12 weeks of treatment is presented.
Related Research Topics
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Trial Locations
- Locations (30)
Cheonan Chungmu Hospital
🇰🇷Cheonan-si, Chungcheongnam-do, South Korea
Woori-hospital
🇰🇷Bucheon-si, Gyeonggi-do, South Korea
Seo Jung Hwa Internal medicine
🇰🇷Gwangmyeong, Gyeonggi-do, South Korea
Samsung Internal medicine
🇰🇷Hanam, Gyeonggi-do, South Korea
Brrunmadi Orthopedics
🇰🇷Seongnam-si, Gyeonggi-do, South Korea
ST.Mary's Will Hospital
🇰🇷Seongnam-si, Gyeonggi-do, South Korea
21Chospital
🇰🇷Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, South Korea
Dr.Yoon's Clinic
🇰🇷Gyeongsan-si, Gyeongsangbuk-do, South Korea
Yeongju gidok hospital
🇰🇷Yeongju, Gyeongsangbuk-do, South Korea
Scroll for more (20 remaining)Cheonan Chungmu Hospital🇰🇷Cheonan-si, Chungcheongnam-do, South Korea