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

A Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Enavogliflozin in Patients With Type II Diabetes Mellitus Accompanied by Hypertension or Dyslipidemia

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Envlo Tablet; Drug: Envlomet SR Tablet

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 Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Ji Yeon Baeg; Phone Number: 82-02-550-8419; Email: bjy469@daewoong.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 12254
    • Recruiting
    • Happy Yonsei Family Medicine Clinic
    • Contact: Sang Hoon Moon; Phone Number: 031-554-6060

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The proportion of study participants reaching the target blood glucose levels of HbA1c < 7.0% or FPG < 126 mg/dL at the 24-week mark compared to baseline was estimated using PASS 14. The minimum number of participants required to generate a two-sided 95% confidence interval is calculated to be 9,604. Considering an approximate dropout rate of 25%, we plan to recruit a total of 12,000 study participants.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target achievement rates for blood glucose	Target achievement rates for blood glucose at 24 weeks	at 24 weeks
Target achievement rates for LDL-C treatment goals	Target achievement rates for LDL-C treatment goals at 24 weeks	at 24 weeks
Target control rates for blood pressure	Target control rates for blood pressure at 24 weeks	at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in HbA1c	change in HbA1c at 12 week compared to baseline	12 week
change in HbA1c	change in HbA1c at 24 week compared to baseline	24 week
change in FPG	change in FPG at 12 week compared to baseline	12 week
change in FPG	change in FPG at 24 week compared to baseline	24 week
percentage of subjects achieved HbA1c < 7 %	percentage of subjects achieved HbA1c < 7 % at 12 week compared to baseline	12 week
percentage of subjects achieved HbA1c < 7 %	percentage of subjects achieved HbA1c < 7 % at 24 week compared to baseline	24 week
percentage of subjects achieved HbA1c < 6.5 %	percentage of subjects achieved HbA1c < 6.5 % at 12 week compared to baseline	12 week
percentage of subjects achieved HbA1c < 6.5 %	percentage of subjects achieved HbA1c < 6.5 % at 24 week compared to baseline	24 week
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)	therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) at 12 week compared to baseline	12 week
therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)	therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %) at 24 week compared to baseline	at 24 week
change in blood pressure (systolic blood pressure, diastolic blood pressure)	change in blood pressure (systolic blood pressure, diastolic blood pressure) at 12 week compared to baseline	at 12 week
change in blood pressure (systolic blood pressure, diastolic blood pressure)	change in blood pressure (systolic blood pressure, diastolic blood pressure) at 24 week compared to baseline	at 24 week
change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride)	change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 12 week compared to baseline	at 12 week
change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride)	change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride) at 24 week compared to baseline	at 24 week

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Sang Hoon Moon, Happy Yonsei Family Medicine Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Hypertension; Diabetes Mellitus, Type 2; Diabetes Mellitus; Dyslipidemias; Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: DWENV_DB_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No