NCT05926414

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 21, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

June 22, 2023

Last Update Submit

August 28, 2025

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • change in HbA1c

    change in HbA1c at 24 weeks compared to baseline

    at 24 weeks

Secondary Outcomes (9)

  • change in HbA1c

    12 weeks

  • change in FPG

    12 weeks

  • change in FPG

    24 weeks

  • percentage of subjects achieved HbA1c < 7 %

    12 weeks

  • percentage of subjects achieved HbA1c < 7 %

    24 weeks

  • +4 more secondary outcomes

Study Arms (1)

patient diagnosed with type2 diabetes mellitus

patient diagnosed with type2 diabetes mellitus

Drug: Enavogliflozin

Interventions

EnavogliflozinDRUG

treated with Envlo tab. 0.3mg

Also known as: Envlo Tablet
patient diagnosed with type2 diabetes mellitus

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • an adult male and female over 19 years of age
  • 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
  • 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

You may not qualify if:

  • Persons with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.)
  • 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)
  • Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment
  • Pregnant women and lactating women
  • A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices
  • A person who is deemed inappropriate to participate in this observational study based on the judgment of other investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NaRi Kim

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Enavogliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 3, 2023

Study Start

September 21, 2023

Primary Completion

January 17, 2025

Study Completion

December 31, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations

KR(1)