Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus

NCT06427083 | Active Not Recruiting

• 1 other identifier: DW_ODNENV_DB_02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study is designed to assess the effects of Envlo Tablet or Envlomet SR Tablet on weight loss and safety in patients with Type 2 diabetes, conducted in real primary care settings over a period of 24 weeks.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• change in BMI

  change in BMI at 24 weeks from baseline

  24 weeks

• change in body weight

  change in body weight at 24 weeks from baseline

  24 weeks

Secondary Outcomes (18)

• change in BMI

  12 weeks

• change in body weight

  12 weeks

• Proportion of subjects achieving ≥ 5% reduction in BMI

  12 weeks

• Proportion of subjects achieving ≥ 5% reduction in BMI

  24 weeks

• Proportion of subjects achieving ≥ 5% reduction in weight

  12 weeks

Study Arms (1)

patient diagnosed with type2 diabetes mellitus

patient diagnosed with type2 diabetes mellitus

Drug: Envlo Tablet; Drug: Envolomet SR Tablet

Interventions

Envlo Tablet DRUG

Enavogliflozin 0.3mg

patient diagnosed with type2 diabetes mellitus

Envolomet SR Tablet DRUG

Enavogliflozin 0.3mg/Metformin1,000mg

patient diagnosed with type2 diabetes mellitus

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The mean and standard deviation of the change from baseline to 12 or 24 weeks in weight and body mass index (BMI) from previously conducted Phase 2 and Phase 3 clinical trials were used as references for calculation using G\*Power 3.1.9.7.

You may qualify if:

• Adults aged 19 to 80 years.
• Patients with Type 2 diabetes who are scheduled to receive initial treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the attending physician's medical judgment, within the following insurance coverage ranges:
• Enavogliflozin monotherapy
• Combination therapy of Enavogliflozin with two agents (metformin)
• Combination therapy of Enavogliflozin with three agents (metformin + DPP-4 inhibitor)
• Patients with obesity beyond the pre-obesity stage according to the 2022 Korean Endocrine Society obesity treatment guidelines:
• Pre-obesity stage: BMI 23\~24.9 kg/m2
• Stage 1 obesity: BMI 25\~29.9 kg/m2
• Stage 2 obesity: BMI 30\~34.9 kg/m2
• Stage 3 obesity: BMI ≥ 35 kg/m2
• Individuals planning to undertake appropriate exercise and dietary therapy for glycemic control during the observational study period.
• Fertile women and men who agree to contraception according to appropriate contraceptive methods during the observational study period or have no plans for pregnancy, adhering to methods such as hormonal contraceptives, intrauterine devices or systems, tubal ligation, vasectomy, dual contraception methods (such as cervical cap and male condom), etc.
• Individuals who have received detailed explanation and have understood the nature of the observational study and the investigational drug, and have provided written consent to participate voluntarily in the observational study and to comply with subject precautions during the study period.

You may not qualify if:

• Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.).
• Individuals contraindicated for Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the approved indications:
• Patients with a history of hypersensitivity reactions to the components of Enavogliflozin or Enavogliflozin Extended-Release Tablets
• Patients with an eGFR (estimated Glomerular Filtration Rate) less than 30 mL/min/1.73m2, end-stage renal disease, or undergoing dialysis
• Patients with moderate to severe hepatic impairment (AST or ALT \> 3 times the upper limit of normal, Total Bilirubin \> 2 times the upper limit of normal, hepatitis or hepatic failure)
• Patients classified as NYHA (New York Heart Association) class III or IV
• Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60 mL/min/1.73m2.
• Patients with unstable weight due to treatment with obesity drugs or weight loss medications within 3 months prior to enrollment or other treatments (surgery, dietary therapy, etc.).
• Individuals with diminished mental capacity.
• Pregnant and lactating women.
• Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices.
• Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Kyung Hee University Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: May 14, 2024
• First Posted: May 23, 2024
• Study Start: June 11, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

KR (1)