Assessing weight loss and safety of Enavogliflozin in Type 2 diabetes patients

An Anonymized, De-identified Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus

This study is testing if a new diabetes medication called Enavogliflozin can help people with Type 2 diabetes lose weight safely over 24 weeks.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 19 Years to 80 Years
• Sex: All
• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry-sponsored)
• Locations: 1 site (Seoul)
• Trial ID: NCT06427083 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness and safety of Enavogliflozin in promoting weight loss among patients with Type 2 diabetes over a 24-week period. Participants will be recruited from primary care settings and will receive either Envlo Tablet or Envlomet SR Tablet based on their physician's judgment. Data collection will include demographic information, physical measurements, vital signs, and clinical indicators, with follow-up visits at 12 and 24 weeks to monitor progress and safety. The study aims to gather real-world evidence on the impact of these medications in routine clinical practice.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 to 80 with Type 2 diabetes who are scheduled to start treatment with Enavogliflozin and have obesity beyond the pre-obesity stage.

Not a fit: Patients who do not have Type 2 diabetes or are not eligible for treatment with Enavogliflozin will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into effective weight management strategies for patients with Type 2 diabetes.

How similar studies have performed: Other studies have shown promising results with similar approaches in managing weight loss in Type 2 diabetes patients, suggesting potential for success.

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.

Where this trial is running

Seoul

• Kyung Hee University Medical Center — Seoul, Korea, Republic of (Recruiting)

Study contacts

• Study coordinator: NaRi Kim

Conditions Type 2 Diabetes Mellitus