Clinical trial NCT05926414: To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus
Official title: A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 15000
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: This study is an observational study conducted in a single group, and was calculated using the Confidence Intervals for One Mean method for the mean by referring to the average and standard deviation of changes at 12 or 24 weeks compared to the baseline of HbA1c levels in previous phase 2 and 3 clinical trials

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in HbA1c
timeFrame: at 24 weeks
Secondary outcomes:
measure: change in HbA1c
timeFrame: 12 weeks
measure: change in FPG
timeFrame: 12 weeks
measure: change in FPG
timeFrame: 24 weeks
measure: percentage of subjects achieved HbA1c < 7 %
timeFrame: 12 weeks
measure: percentage of subjects achieved HbA1c < 7 %
timeFrame: 24 weeks
measure: percentage of subjects achieved HbA1c < 6.5 %
timeFrame: 12 weeks
measure: percentage of subjects achieved HbA1c < 6.5 %
timeFrame: 24 weeks
measure: therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)
timeFrame: 12 weeks
measure: therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: NaRi Kim
Study officials:
References: