Clinical trial NCT06427083: Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus
Official title: An Anonymized, De-identified Registry Study to Determine the Effectiveness and Safety of Weight Loss With Enavogliflozin in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-05-23
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The study plans to recruit patients with Type 2 diabetes who are scheduled to receive Envlo Tablet or Envlomet SR Tablet based on the attending physician's medical judgment, regardless of previous diabetes treatment. However, voluntary consent from patients is required for participation in the study, even if Envlo Tablet or Envlomet SR Tablet are prescribed.

Data collection will occur for up to 24 weeks post-Envlo Tablet or Envlomet SR Tablet initiation, capturing demographic information, physical measurements, vital signs, and lifestyle factors. Follow-up visits at 12 weeks and 24 weeks post-baseline will be conducted to collect data, including clinical indicators, safety evaluations, and adverse events. Data will be collected based on routine clinical records, with no mandatory study-specific visits or interventions.

Overall, this observational study aims to collect data on demographics, physical measurements, vital signs, and clinical indicators in patients receiving Envlo Tablet or Envlomet SR Tablet in real-world clinical settings, utilizing information obtained during routine patient care processes.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 to 80 years.
2. 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)
3. 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
4. Individuals planning to undertake appropriate exercise and dietary therapy for glycemic control during the observational study period.
5. 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.
6. 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.

Exclusion Criteria:

1. Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.).
2. 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
3. Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60 mL/min/1.73m2.
4. 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.).
5. Individuals with diminished mental capacity.
6. Pregnant and lactating women.
7. Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices.
8. Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment.

Primary outcomes:
measure: change in BMI
timeFrame: 24 weeks
measure: change in body weight
timeFrame: 24 weeks
Secondary outcomes:
measure: change in BMI
timeFrame: 12 weeks
measure: change in body weight
timeFrame: 12 weeks
measure: Proportion of subjects achieving ≥ 5% reduction in BMI
timeFrame: 12 weeks
measure: Proportion of subjects achieving ≥ 5% reduction in BMI
timeFrame: 24 weeks
measure: Proportion of subjects achieving ≥ 5% reduction in weight
timeFrame: 12 weeks
measure: Proportion of subjects achieving ≥ 5% reduction in weight
timeFrame: 24 weeks
measure: Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.)
timeFrame: 12 weeks
measure: Change in body composition analyzer indicators (body fat mass, visceral fat mass, muscle mass, waist/hip circumference, etc.)
timeFrame: 24 weeks
measure: Change in HbA1c
timeFrame: 12 weeks
measure: Change in HbA1c
timeFrame: 24 weeks
measure: Change in FPG
timeFrame: 12 weeks
measure: Change in FPG
timeFrame: 24 weeks
measure: Proportion of subjects achieving HbA1c < 7%
timeFrame: 12 weeks
measure: Proportion of subjects achieving HbA1c < 7%
timeFrame: 24 weeks
measure: Proportion of subjects achieving HbA1c < 6.5%
timeFrame: 12 weeks
measure: Proportion of subjects achieving HbA1c < 6.5%
timeFrame: 24 week
measure: Proportion of subjects achieving therapeutic response [change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) > 0.5% or HbA1c < 7%]
timeFrame: 12 weeks
measure: Proportion of subjects achieving therapeutic response [change in HbA1c (baseline HbA1c - HbA1c at each evaluation time point) > 0.5% or HbA1c < 7%]
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
Study officials:
References: