Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus

Korábbi kezelés

• Patients with unstable weight due to treatment with obesity drugs or weight loss medications within 3 months prior to enrollment or other treatments (surgery, dietary therapy, etc.).
• Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices.

Más betegség

• Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.).

Laborértékek

• Individuals contraindicated for Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the approved indications:
  • Patients with a history of hypersensitivity reactions to the components of Enavogliflozin or Enavogliflozin Extended-Release Tablets
  • Patients with an eGFR (estimated Glomerular Filtration Rate) less than 30 mL/min/1.73m2, end-stage renal disease, or undergoing dialysis
  • Patients with moderate to severe hepatic impairment (AST or ALT > 3 times the upper limit of normal, Total Bilirubin > 2 times the upper limit of normal, hepatitis or hepatic failure)
  • Patients classified as NYHA (New York Heart Association) class III or IV
• Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60 mL/min/1.73m2.

Egyéb

• Individuals with diminished mental capacity.
• Pregnant and lactating women.
• Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.

• Adults aged 19 to 80 years.
• Patients with Type 2 diabetes who are scheduled to receive initial treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the attending physician's medical judgment, within the following insurance coverage ranges:
  • Enavogliflozin monotherapy
  • Combination therapy of Enavogliflozin with two agents (metformin)
  • Combination therapy of Enavogliflozin with three agents (metformin + DPP-4 inhibitor)
• Patients with obesity beyond the pre-obesity stage according to the 2022 Korean Endocrine Society obesity treatment guidelines:
  • Pre-obesity stage: BMI 23~24.9 kg/m2
  • Stage 1 obesity: BMI 25~29.9 kg/m2
  • Stage 2 obesity: BMI 30~34.9 kg/m2
  • Stage 3 obesity: BMI ≥ 35 kg/m2
• Individuals planning to undertake appropriate exercise and dietary therapy for glycemic control during the observational study period.
• Fertile women and men who agree to contraception according to appropriate contraceptive methods during the observational study period or have no plans for pregnancy, adhering to methods such as hormonal contraceptives, intrauterine devices or systems, tubal ligation, vasectomy, dual contraception methods (such as cervical cap and male condom), etc.
• Individuals who have received detailed explanation and have understood the nature of the observational study and the investigational drug, and have provided written consent to participate voluntarily in the observational study and to comply with subject precautions during the study period.