Actively Recruiting

Age: 19Years +
All Genders
ID06647888

Observational Study of Envlo and Envlomet SR Tablets in Type 2 Diabetes Patients With Hypertension or Dyslipidemia to Evaluate Safety and Efficacy

Led by Daewoong Pharmaceutical Co. LTD. · Updated on 2025-01-23

12000

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Envlo and Envlomet SR tablets in adults with type 2 diabetes who also have hypertension or dyslipidemia. This is a multi-center, non-interventional observational study tracking patients over 24 weeks in real-world clinical settings. The study includes patients who are already taking or are scheduled to start taking these medications. Participants will receive either Envlo tablet 0.3 mg or Envlomet SR tablet containing 0.3 mg Envlo and 1,000 mg Metformin, based on their doctor's decision. The study does not require any additional treatments or visits beyond routine care. Data collection will include medical records and measurements taken during regular clinical visits over the 24-week period. Throughout the study, researchers will gather information on participants' demographics, body measurements, vital signs, and medical records. They will assess how well patients achieve blood glucose, LDL cholesterol, and blood pressure targets at 24 weeks. There are no mandatory extra visits or tests required, and participant safety and treatment effects will be monitored in the usual clinical environment.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 years or older
  • Diagnosed with type 2 diabetes and have hypertension or dyslipidemia
  • Currently receiving or scheduled to receive Envlo Tablet or Envlomet SR Tablet
  • Voluntarily agree to participate and comply with study precautions
  • Understand the study and are capable of completing it
Not Eligible

You will not qualify if you...

  • Patients starting Envlo or Envlomet treatment with an eGFR less than 60 ml/min/1.73m²
  • Patients with diabetes other than type 2 (such as type 1 diabetes, diabetic ketoacidosis, gestational diabetes)
  • Those prohibited from taking Envlo due to allergy or adverse reaction
  • Patients with end-stage kidney disease or on dialysis
  • Patients with moderate to severe liver failure
  • Patients classified as Class III or IV by New York Heart Association
  • Patients with unstable weight due to treatments or medications within 3 months
  • Pregnant or breastfeeding women
  • Participants currently in other clinical trials involving drugs or devices
  • Anyone deemed unsuitable for the study by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Happy Yonsei Family Medicine Clinic

Seoul, South Korea, 12254

Actively Recruiting

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Research Team

J

Ji Yeon Baeg

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Frequently Asked Questions

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