Last updated: February 20, 2025
Sponsor: Seoul National University Bundang Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Diabetic Gastroparesis
Diabetic Vitreous Hemorrhage
Diabetes And Hypertension
Treatment
Metformin
Empagliflozin 10 mg
Clinical Study ID
NCT06846411
B-2201-732-003
2021-02251
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants were eligible if they had T2D with an HbA1c between 6.5% and 10.0%,were between 20 and 75 years of age, and had not received any anti-diabeticmedications for at least eight weeks prior to screening.
Exclusion
Exclusion Criteria:
- individuals with a body mass index (BMI) <18.5 kg/m² or ≥40 kg/m², clinicallysignificant hepatic impairment (e.g., hepatic cirrhosis, portal hypertension,chronic active hepatitis), or a history of acute cardiovascular events (e.g.,coronary artery disease, cerebrovascular disease, peripheral arterial disease)within two months prior to enrollment. Participants with CKD (eGFR <60 mL/min/1.73m²) or end-stage renal disease (eGFR <15 mL/min/1.73 m² or on dialysis) were alsoexcluded.
Additional exclusion criteria included uncontrolled hypertension (BP ≥160/100 mmHg), New York Heart Association (NYHA) class III or IV heart failure, chronic oral corticosteroid use (>30 consecutive days), a history of cancer (except basal cell carcinoma) within the past five years, or significant dyslipidemia (triglycerides >1,000 mg/dL or LDL cholesterol >250 mg/dL).
Study Design
Total Participants: 46
Treatment Group(s): 2
Primary Treatment: Metformin
Phase: 4
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2025
Connect with a study center
SNUBH
Seongnam,
Korea, Republic ofActive - Recruiting
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