NCT06427083

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Envlo Tablet	Enavogliflozin 0.3mg
DRUG	Envolomet SR Tablet	Enavogliflozin 0.3mg/Metformin1,000mg

Timeline

• Start date: 2024-06-11
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-05-23
• Last updated: 2025-09-02

Locations

1 site across 1 country: South Korea