Esgliteo Post Marketing Surveillance (PMS) in Korean Patients With Type 2 Diabetes Mellitus

Boehringer Ingelheim1,053 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,053

Conditions

Diabetes Mellitus, Type 2

Interventions

Empagliflozin/LinagliptinDRUG

Participants received Empagliflozin 10mg or 25mg and Linagliptin 5mg (Fixed Dose) Film-coated tablets orally once daily with or without food.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (30)

Outcomes

Primary Outcomes

All Reported Adverse Events Collected From Subjects Taking at Least One Dose of ESGLITEO®

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.

Time frame: From first trial drug administration up to 24 weeks.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 12 Weeks of Treatment

The mean change from baseline in glycosylated hemoglobin (HbA1c) after 12 weeks of treatment is presented.

Time frame: From the first trial drug administration up to 12 weeks.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 24 Weeks of Treatment

The mean change from baseline in glycosylated hemoglobin (HbA1c) after 24 weeks of treatment is presented.

Time frame: From the first trial drug administration up to 24 weeks.

Secondary Outcomes

Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 12 Weeks of Treatment

The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 12 weeks following trial drug administration are presented.

Time frame: 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

The percentage of patients whose glycosylated hemoglobin (HbA1c) levels dropped below 7% at 24 weeks following trial drug administration are presented.

Time frame: From the first trial drug administration up to 24 weeks.

Percentage of Participants With Occurrence of Relative Effectiveness Response After 12 Weeks of Treatment

Data from ClinicalTrials.gov

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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

...and 20 more locations

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®.

Time frame: From the first trial drug administration up to 12 weeks.

Percentage of Participants With Occurrence of Relative Effectiveness Response After 24 Weeks of Treatment

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®.

Time frame: From the first trial drug administration up to 24 weeks.

Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment

Change from baseline in fasting plasma glucose (FPG) of participants after 12 weeks of treatment is presented.

Time frame: From the first trial drug administration up to 12 weeks.

Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment

Change from baseline in fasting plasma glucose (FPG) of participants after 24 weeks of treatment is presented.

Time frame: From the first trial drug administration up to 24 weeks.

Change From Baseline in Body Weight After 12 Weeks of Treatment

Change from baseline in body weight of participants after 12 weeks of treatment is presented.

Time frame: From the first trial drug administration up to 12 weeks.

Change From Baseline in Body Weight After 24 Weeks of Treatment

Change from baseline in body weight of participants after 24 weeks of treatment is presented.

Time frame: 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

Mean change from baseline in blood pressure (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) of participants after 12 weeks of treatment is presented.

Time frame: 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

Mean change from baseline in blood pressure (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) of participants after 24 weeks of treatment is presented.

Time frame: From the first trial drug administration up to 24 weeks.