A regulatory requirement non-interventional study to monitor the safety and effectiveness of Glyxambi (empagliflozin/linagliptin, 10/5mg, 25/5mg) in Korean patients with type 2 diabetes mellitus

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Study drug and medical condition

• Medicinal product name:
  GLYXAMBI

  GLYXAMBI
• Medicinal product name, other:
  'Esgliteo' is regional brand name in Korea.
• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN

  LINAGLIPTIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BD19) linagliptin and empagliflozin

  linagliptin and empagliflozin
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Audilt T2DM Patients
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  600

Study design details

• Study design:
  Prospective, Non-interventional, Multi-centre, Single-country Study
• Main study objective:
  To monitor the safety profile and effectiveness of Esgliteo in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting
• Setting:
  1. Patients diagnosed with type 2 diabetes mellitusin Korea; 2. ESGLITEO® is administered as an adjunct to diet and exercise therapy to improve glycaemic controlin patients with type 2 diabetes mellitus; ; 3. Inclusion Criteria: ; -Patients who have startedtreatment withESGLITEO® for the first time in accordance with the label approvedin Korea; -Patients aged 19 yearsor olderat enrollment; -Patients who have signed the Informed Consent Form for the Use of Personal Information; ; 4. Exclusion Criteria: ; -Patients with previous exposure to ESGLITEO®; -Patients with hypersensitivity to the active ingredients of this drug, empagliflozin and/or linagliptin, orany of the excipients of this drug; -Patients with type 1 diabetes or diabetic ketoacidosis; -Patients with estimated Glomerular Filtration Rate (eGFR) < 45mL/min/1.73m2, end stage renal disease, or patients on dialysis; -Patients for whom the use of empagliflozin/linagliptinis contraindicated according to the prescribinginformationof; ESGLITEO®
• Comparators:
  Not applicable
• Outcomes:
  To monitor the safety profile and effectiveness of Esgliteo in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting, Change from baseline in HbA1c after 12 weeks and/or 24 weeks of treatment
• Data analysis plan:
  1) Analysis of Demographic Data Demographic data and the health status of subjects for the safety evaluation will be analysed descriptively. For continuous data, mean, standard deviation, minimum value, and maximum value will be described, while for categorical data, frequency will be shown. 2) Analysis of Safety Among the subjects of safety evaluation, the number of subjects with adverse event incurred and the number of adverse events incurred should be calculated, and the frequency of adverse events and the 95% confidence interval should be presented. 3) Analysis of Effectiveness Mean, standard deviation, minimum value, maximum value, and median of changes in glycosylated hemoglobin(HbA1c) and fasting plasma glucose(FPG), weight, and blood pressure, which were measured at the last visit versus baseline, should be presented, and if there is a difference before administration versus after administration should be analyzed using paired t-test.
• Summary results:
  During this re-examination period, the incidence of the Adverse Event (AE) reported in 616 subjects for safety evaluation was 3.41% (21/616, 26 cases). Among these, the incidence of Adverse Drug Reactions (ADRs), in which a causal relationship with this drug could not be ruled out, was 0.65% (4/616, 4 cases), and all were found to be non-serious ADRs. The incidence of Serious Adverse Event (SAE) was found to be 0.49% (3/616, 4 cases), and there was no Serious Adverse Drug Reaction (SADR) for which a causal relationship with this drug could not be ruled out. Unexpected Adverse Event (UAE) was found to be 1.46% (9/616 subjects, 10 cases), and among these, Unexpected Adverse Drug Reaction (UADR), in which a causal relationship with the drug could not be ruled out, was found to be 0.16% (1/616 subjects, 1 case).; Adverse Event of Special Interest (AESI) was found to be 0.16% (1/616 subjects, 1 case), and there were no AEs that led to discontinuation of the drug.; The results of the final effectiveness evaluation at 12 weeks after administration in 190 subjects for effectiveness evaluation showed that57.89% (110/190 subjects) were ‘Improved’, 39.47% (75/190subjects) were ‘Unchanged’, and 2.63% (5/190subjects) were ‘Aggravated’. When ‘Improved’ was classified as ‘effective’ and ‘Unchanged’ or ‘Aggravated’ as ‘ineffective’, the effective rate of ESGLITEO® was 57.89% (110/190 subjects).; According to this post-marketing surveillance for ESGLITEO®, no unusual tendency to be carefully observed regarding safety and efficacy was found, and no significant new information that could affect risk versus benefit assessment was identified.