Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or Dyslipidemia

Recruiting

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT06647888
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

This observational study is a non-interventional, multi-center, prospective observational study aimed at tracking the efficacy and safety of Envlo or Envlomet SR tablets for 24 weeks in patients with type 2 diabetes and hypertension or dyslipidemia who are currently taking or are scheduled to take Envlo or Envlomet SR tablets in an actual clinical setting.

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: 2024-10-16
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-18
• Study Start: 2024-12-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12000

Inclusion Criteria

1. An adult male and female over 19 years of age
2. A patient diagnosed with type 2 diabetes who have hypertension or dyslipidemia and are currently receiving Envlo Tab/ Envlomet SR Tab or are scheduled to receive Envlo Tab/ Envlomet SR Tab
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 4 ) A person who understands the content of this observational study, are cooperative with the research process, and are considered capable of participating until the study's completion

Exclusion Criteria

1. Among patients who begin treatment with Envlo Tab/ Envlomet Tab at the time of registration, those with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m²

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

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

   • Patients who overreact to Envlo Tab or Envlomet Tab components and have a history of it
   • Patients with an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m², 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)

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

5. Pregnant women and lactating women

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

7. A person who is considered inappropriate to participate in this observational study based on the judgment of investigators

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target control rates for blood pressure	at 24 weeks	Target control rates for blood pressure at 24 weeks
Target achievement rates for blood glucose	at 24 weeks	Target achievement rates for blood glucose at 24 weeks
Target achievement rates for LDL-C treatment goals	at 24 weeks	Target achievement rates for LDL-C treatment goals at 24 weeks

Secondary Outcome Measures

Name	Time	Method
change in HbA1c	24 week	change in HbA1c at 24 week compared to baseline
change in FPG	24 week	change in FPG at 24 week compared to baseline
percentage of subjects achieved HbA1c < 7 %	24 week	percentage of subjects achieved HbA1c \< 7 % at 24 week compared to baseline
percentage of subjects achieved HbA1c < 6.5 %	24 week	percentage of subjects achieved HbA1c \< 6.5 % at 24 week compared to baseline
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)	at 24 week	therapeutic response(change in HbA1c \> 0.5 % OR HbA1c \< 7 %) at 24 week compared to baseline
change in blood pressure (systolic blood pressure, diastolic blood pressure)	at 24 week	change in blood pressure (systolic blood pressure, diastolic blood pressure) at 24 week compared to baseline
change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride)	at 24 week	change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 24 week compared to baseline

Trial Locations

Locations (1)

Happy Yonsei Family Medicine Clinic; 🇰🇷 Seoul, Korea, Republic of