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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926414
• Other study ID #: DWENV_DB_01
• Status: Recruiting
• Start date: September 21, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: NaRi Kim
• Phone: 82-10-6611-7051
• Email: nrkim209[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Enavogliflozin
treated with Envlo tab. 0.3mg
• Enavogliflozin
Envlomet SR Tablet 0.3/1,000mg

Locations

Country	Name	City	State
Korea, Republic of	NaRi Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in HbA1c	change in HbA1c at 24 weeks compared to baseline	at 24 weeks
Secondary	change in HbA1c	change in HbA1c at 12 weeks compared to baseline	12 weeks
Secondary	change in FPG	change in FPG at 12 weeks compared to baseline	12 weeks
Secondary	change in FPG	change in FPG at 24 weeks compared to baseline	24 weeks
Secondary	percentage of subjects achieved HbA1c < 7 %	percentage of subjects achieved HbA1c < 7 % at 12 weeks compared to baseline	12 weeks
Secondary	percentage of subjects achieved HbA1c < 7 %	percentage of subjects achieved HbA1c < 7 % at 24 weeks compared to baseline	24 weeks
Secondary	percentage of subjects achieved HbA1c < 6.5 %	percentage of subjects achieved HbA1c < 6.5 % at 12 weeks compared to baseline	12 weeks
Secondary	percentage of subjects achieved HbA1c < 6.5 %	percentage of subjects achieved HbA1c < 6.5 % at 24 weeks compared to baseline	24 weeks
Secondary	therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)	therapeutic response at 12 weeks compared to baseline	12 weeks
Secondary	therapeutic response(change in HbA1c > 0.5 % OR HbA1c < 7 %)	therapeutic response at 24 weeks compared to baseline	24 weeks