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

Launched by DAEWOONG PHARMACEUTICAL CO. LTD. · May 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Enavogliflozin on weight loss and safety in adults with Type 2 diabetes. The trial is taking place in real healthcare settings over a period of 24 weeks. Participants will be adults between the ages of 19 and 80 who are starting treatment with Enavogliflozin and have obesity, as defined by specific body mass index (BMI) ranges. Eligible participants should also be willing to follow a healthy diet and exercise plan during the study.

If you join this study, you will be monitored for any changes in weight and any potential side effects of the medication. It's important to note that not everyone can participate; for example, individuals with types of diabetes other than Type 2, those who have certain kidney or liver conditions, and pregnant or breastfeeding women are excluded. This trial aims to gather real-world information about the effectiveness of Enavogliflozin in helping people with Type 2 diabetes lose weight safely.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults aged 19 to 80 years.
• 2. 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)
• 3. 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
• • 4. Individuals planning to undertake appropriate exercise and dietary therapy for glycemic control during the observational study period.
• • 5. 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.
• • 6. 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.
• Exclusion Criteria:
• • 1. Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.).
• 2. 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
• • 3. Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60 mL/min/1.73m2.
• • 4. 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.).
• • 5. Individuals with diminished mental capacity.
• • 6. Pregnant and lactating women.
• • 7. Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices.
• • 8. Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.