Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or Dyslipidemia

NCT06647888 | Recruiting

• 1 other identifier: DWENV_DB_02
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Target achievement rates for blood glucose

  Target achievement rates for blood glucose at 24 weeks

  at 24 weeks

• Target achievement rates for LDL-C treatment goals

  Target achievement rates for LDL-C treatment goals at 24 weeks

  at 24 weeks

• Target control rates for blood pressure

  Target control rates for blood pressure at 24 weeks

  at 24 weeks

Secondary Outcomes (14)

• change in HbA1c

  12 week

• change in HbA1c

  24 week

• change in FPG

  12 week

• change in FPG

  24 week

• percentage of subjects achieved HbA1c < 7 %

  12 week

Interventions

Envlo Tablet DRUG

Envlo Tab. 0.3mg

Also known as: Enavogliflozin 0.3mg

Envlomet SR Tablet DRUG

Envlomet SR Tablet 0.3/ Metformin1,000mg

Also known as: Enavogliflozin 0.3mg/ Metformin1,000mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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
• A patient 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 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)
• 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 considered inappropriate to participate in this observational study based on the judgment of investigators

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Happy Yonsei Family Medicine Clinic

Seoul, 12254, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Enavogliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sang Hoon Moon

  Happy Yonsei Family Medicine Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Yeon Baeg

CONTACT

82-02-550-8419; bjy469@daewoong.co.kr

Study Design

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

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: December 3, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

KR (1)