An Anonymized, De-identified Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- change in body weight
研究概览
简要总结
This observational study is designed to assess the effects of Envlo Tablet or Envlomet SR Tablet on weight loss and safety in patients with Type 2 diabetes, conducted in real primary care settings over a period of 24 weeks.
详细描述
The study plans to recruit patients with Type 2 diabetes who are scheduled to receive Envlo Tablet or Envlomet SR Tablet based on the attending physician's medical judgment, regardless of previous diabetes treatment. However, voluntary consent from patients is required for participation in the study, even if Envlo Tablet or Envlomet SR Tablet are prescribed.
Data collection will occur for up to 24 weeks post-Envlo Tablet or Envlomet SR Tablet initiation, capturing demographic information, physical measurements, vital signs, and lifestyle factors. Follow-up visits at 12 weeks and 24 weeks post-baseline will be conducted to collect data, including clinical indicators, safety evaluations, and adverse events. Data will be collected based on routine clinical records, with no mandatory study-specific visits or interventions.
Overall, this observational study aims to collect data on demographics, physical measurements, vital signs, and clinical indicators in patients receiving Envlo Tablet or Envlomet SR Tablet in real-world clinical settings, utilizing information obtained during routine patient care processes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.).
- •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/1.73m
- •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 with diminished mental capacity.
- •Pregnant and lactating women.
- •Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices.
- •Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.
研究组 & 干预措施
patient diagnosed with type2 diabetes mellitus
patient diagnosed with type2 diabetes mellitus
干预措施: Envlo Tablet (Drug)
patient diagnosed with type2 diabetes mellitus
patient diagnosed with type2 diabetes mellitus
干预措施: Envolomet SR Tablet (Drug)
结局指标
主要结局
change in body weight
时间窗: 24 weeks
change in body weight at 24 weeks from baseline
change in BMI
时间窗: 24 weeks
change in BMI at 24 weeks from baseline
次要结局
- Proportion of subjects achieving therapeutic response [change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) > 0.5% or HbA1c < 7%](24 weeks)
- change in BMI(12 weeks)
- change in body weight(12 weeks)
- Change in FPG(24 weeks)
- Proportion of subjects achieving HbA1c < 6.5%(24 week)
- Proportion of subjects achieving ≥ 5% reduction in BMI(24 weeks)
- Proportion of subjects achieving ≥ 5% reduction in weight(24 weeks)
- Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.)(24 weeks)
- Change in HbA1c(24 weeks)
- Proportion of subjects achieving HbA1c < 7%(24 weeks)