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Completed

NCT Number: NCT05130463

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cheonan Chungmu Hospital, Cheonan-si, Chungcheongnam-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin/Linagliptin

Drug

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

Other names: Esgliteo®

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

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

    Time frame: 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.

  2. Percentage of Participants With HbA1c Reaching Less Than 7% From Baseline (Target Effectiveness Response Rate) After 24 Weeks of Treatment

    Time frame: 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.

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

    Time frame: 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®.

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

    Time frame: 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®.

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

    Time frame: 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.

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

    Time frame: 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.

  7. Change From Baseline in Body Weight After 12 Weeks of Treatment

    Time frame: 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.

  8. Change From Baseline in Body Weight After 24 Weeks of Treatment

    Time frame: 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.

  9. Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 12 Weeks of Treatment

    Time frame: 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.

  10. Change From Baseline in Blood Pressure (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP]) After 24 Weeks of Treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 23, 2021
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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