To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Enavogliflozin

• Registration Number: NCT05926414
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

This observation study is designed as a prospective, multi-organ observation study to confirm the blood sugar control effect and safety of ENVLO tablet or Envlomet SR Tablet administration for 24 weeks in patients with type 2 diabetes who are scheduled to administer ENVLO tablet in the actual treatment environment.

Detailed Description

This observational study planned recruit population of type 2 diabetes patients who are scheduled to administer ENVLO tablet or Envlomet SR Tablet according to the medical judgment of the researcher (doctor in charge) based on permission (efficacy \& effect, usage \& dose, usage precautions, etc.) in the actual treatment environment.

This observational study will be conducted in an actual treatment environment regardless of whether ENVLO tablet or Envlomet SR Tablet was administered or not.

Information such as demographic information, body measurement, and vital signs performed will be collected up to 24 weeks after ENVLO tablet or Envlomet SR Tablet administration.

Data will be collected based on medical records recorded in the actual treatment environment, and there is no mandatory visit, examination, or treatment in this observation study.

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Study Start: 2023-09-21
• Primary Completion: 2025-01-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

1. an adult male and female over 19 years of age
2. A person who is a type 2 diabetic and is planed to take Envlo Tab or Envloment SR Tab for the first time according to the medical judgment of the Investigator based on the permit
3. A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied

Exclusion Criteria

1. Persons with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.)

2. A person who is prohibited from administering in accordance with the permission of Envlo Tab.'s

   • Patients who overreact to Envlo Tab. or Envlo Tab. components and have a history of it
   • eGFR (estimated global filtration rate) patients below 30 mL/min/1.73 m2, end-stage renal disease or on dialysis
   • Patients with moderate and severe liver failure (AST or ALT > 3x normal upper limit, Total Bilirubin > 2x normal upper limit, hepatitis or liver failure)
   • Class III or IV by classification of the New York Heart Association (NYHA)

3. Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment

4. Pregnant women and lactating women

5. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices

6. A person who is deemed inappropriate to participate in this observational study based on the judgment of other investigators

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient diagnosed with type2 diabetes mellitus	Enavogliflozin	patient diagnosed with type2 diabetes mellitus

Primary Outcome Measures

Name	Time	Method
change in HbA1c	at 24 weeks	change in HbA1c at 24 weeks compared to baseline

Secondary Outcome Measures

Name	Time	Method
change in HbA1c	12 weeks	change in HbA1c at 12 weeks compared to baseline
change in FPG	24 weeks	change in FPG at 24 weeks compared to baseline
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)	24 weeks	therapeutic response at 24 weeks compared to baseline
percentage of subjects achieved HbA1c < 7 %	24 weeks	percentage of subjects achieved HbA1c \< 7 % at 24 weeks compared to baseline
percentage of subjects achieved HbA1c < 6.5 %	24 weeks	percentage of subjects achieved HbA1c \< 6.5 % at 24 weeks compared to baseline

Trial Locations

Locations (1)

NaRi Kim; 🇰🇷 Seoul, Korea, Republic of