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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427083
• Other study ID #: DW_ODNENV_DB_02
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: NaRi Kim
• Phone: 82-10-6611-7051
• Email: nrkim209[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus
• Weight Loss

Intervention

Drug:
• Envlo Tablet
Enavogliflozin 0.3mg
• Envolomet SR Tablet
Enavogliflozin 0.3mg/Metformin1,000mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in BMI	change in BMI at 24 weeks from baseline	24 weeks
Primary	change in body weight	change in body weight at 24 weeks from baseline	24 weeks