Clinical trial NCT06647888: Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or Dyslipidemia
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-10-18
Enrollment: 12000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target achievement rates for blood glucose
timeFrame: at 24 weeks
measure: Target achievement rates for LDL-C treatment goals
timeFrame: at 24 weeks
measure: Target control rates for blood pressure
timeFrame: at 24 weeks
Secondary outcomes:
measure: change in HbA1c
timeFrame: 12 week
measure: change in HbA1c
timeFrame: 24 week
measure: change in FPG
timeFrame: 12 week
measure: change in FPG
timeFrame: 24 week
measure: percentage of subjects achieved HbA1c < 7 %
timeFrame: 12 week
measure: percentage of subjects achieved HbA1c < 7 %
timeFrame: 24 week
measure: percentage of subjects achieved HbA1c < 6.5 %
timeFrame: 12 week
measure: percentage of subjects achieved HbA1c < 6.5 %
timeFrame: 24 week
measure: therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)
timeFrame: 12 week
measure: therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)
timeFrame: at 24 week
measure: change in blood pressure (systolic blood pressure, diastolic blood pressure)
timeFrame: at 12 week
measure: change in blood pressure (systolic blood pressure, diastolic blood pressure)
timeFrame: at 24 week
measure: change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride)
timeFrame: at 12 week
measure: change in lipid profiles (Total Cholesterol, LDL-C, HDL-C, Triglyceride)
timeFrame: at 24 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Happy Yonsei Family Medicine Clinic
Study officials:
affiliation: Happy Yonsei Family Medicine Clinic
name: Sang Hoon Moon
role: PRINCIPAL_INVESTIGATOR
References: