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Completed

NCT Number: NCT02848833

JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

To monitor the safety profile and effectiveness of Empagliflozin in Korea 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–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have been started on JARDIANCE® 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

  • Known hypersensitivity to empagliflozin or any of its excipients
  • Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis
  • Patients with persistent estimated Glomerular Filtration Rate <60 mL/min/1.73 m2,end stage renal disease or on dialysis
  • Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  • Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®

Treatment and study plan

JARDIANCE 10mg

Drug

T2DM with JARDIANCE 10mg

JARDIANCE 25mg

Drug

MT2DM with JARDIANCE 25mgax

Primary outcomes

  1. Percentage of Participants With Any Adverse Events

    Time frame: 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.

  2. Percentage of Participants With Adverse Events Relating to Study Drug

    Time frame: 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.

  3. Percentage of Participants With Unexpected Adverse Events

    Time frame: 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.

  4. Percentage of Participants With Adverse Events of Special Interest

    Time frame: 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

  5. Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit

    Time frame: 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.

  2. Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit

    Time frame: 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.

  3. Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit

    Time frame: 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

  4. Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit

    Time frame: 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.

  5. Change From Baseline in Body Weight at Last Visit

    Time frame: 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.

  6. Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit

    Time frame: 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.

  7. Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit

    Time frame: 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.

  8. Number of Participants Per Final Effectiveness Assessment Category at Last Visit

    Time frame: 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.).

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 JARDIANCE® (Empagliflozin, 10mg, 25mg, q.d.) in Korean Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2016
Registry last updated
May 11, 2021

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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