The goal of this clinical trial is to learn PK and PD of YG1699 in patients with diabetes and renal dysfuction.
Participants will:
Take YG1699 or a placebo every day for 8 days. Visit the clinic 7 times for checkups and tests. Keep a diary of their symptoms. Estimate PK data from a single dose of YG1699. Estimate PD data at baseline and the last day.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Ability to provide informed consent
2. Male or female patients ,age between 18 and 70 at screening
3. Meet the diagnostic criteria for diabetic nephropathy, including patients with type 1 or type 2 diabetes;
4. Fasting blood glucose \<11.1 mmol/L, stable on baseline anti-diabetic medication
5. No history of SGLT2i use within the past month
6. Hemodialysis patients must have maintenance hemodialysis for more than 3 months, with 3 sessions per week (limited to HD or HDF treatment), and spKt/V\>1.2 within 6 months
7. The patient has not used glucocorticoids, calcineurin inhibitors (cyclosporine, tacrolimus), etc. that affect blood sugar within the past month before signing the informed consent form
8. The baseline diabetes management medication regimen has been stable within the past 2 weeks.
Exclusion Criteria:
1. Hypoglycemia occurs more than 2 times in one month
2. History of ketoacidosis
3. Patients who are being treated with swiram and digoxin
4. Patients with acute kidney injury (serum creatinine increased by ≥ 50% within 1 week)
5. Abnormal liver function (ALT \> 3 times the upper limit of normal value)
6. Hemoglobin \< 80g/L or \> 150g/L
7. The blood pressure of patients with recent symptomatic hypotension is lower than 90/60 mmHg
8. There is acute myocardial infarction stroke infection in the past month
9. There is systemic active infection or uncured tumor
10. The dialysis regimen of HD patients included HP treatment
11. Participating in other interventional clinical studies
12. Pregnant or lactating women
13. Other situations that the researcher thinks are not suitable for joining the study
Primary outcome measure(s)
YG1699 concentration in plasma at different time — 0 hour (h), 0.5h, 1h, 2h, 4h, 8h and 12h after the first dose of YG1699 (Day1); 24 hours after the first dose of YG1699 (Day2 morning) single-dose pharmacokinetic
Trial sites (1)
Facility
City
Region
Status
Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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