Study to Evaluate the Efficacy and Safety of Envlo Tablet in Patients With Type II Diabetes Mellitus

A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Envlo Tablet in Patients With Type II Diabetes Mellitus

This observation study is designed as a prospective, multi-organ observation study to confirm the blood sugar control effect and safety of ENVLO tablet administration for 24 weeks in patients with type 2 diabetes who are scheduled to administer ENVLO tablet in the actual treatment environment.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Enavogliflozin

Detailed Description

This observational study planned recruit population of type 2 diabetes patients who are scheduled to administer ENVLO 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 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 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): 10000

Contacts and Locations

• Study Contact: Name: NaRi Kim; Phone Number: 82-10-6611-7051; Email: nrkim209@daewoong.co.kr

Participation Criteria

Eligibility Criteria

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

• 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

Description

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. 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient diagnosed with type2 diabetes mellitus	Drug: Enavogliflozin; treated with Envlo tab. 0.3mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c (%) changes	HbA1c (%) changes at 24 weeks compared to baseline	at 24 weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DWENV_DB_01

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