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Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.

China106 participantsStarted 2024-02-20

Plain-language summary

The main purpose of this study is to explore the improvement of renal function before and after the intervention of dorzagliatin in patients with type 2 diabetes.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age:18-75 years old, male and female.
✓. Patients with type 2 diabetes mellitus, type 2 diabetes mellitus diagnosis criteria: according to the "Chinese Type 2 Diabetes Mellitus Prevention and Treatment Guide (2020 Edition).
✓. UACR 30-299mg/g.
✓. eGFR ≥60mL/min/1.73m².
✓. HbA1c 7.0-10.5%.

Exclusion criteria

✕. Pregnant and lactating women and women of childbearing age who do not want to take reliable contraceptive measures.
✕. Known allergic history to dorzagliatin/gliclazide/metformin.
✕. Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or hypoglycemic coma, etc.
✕. Serious impairment of heart, liver, kidney and other organs.
✕. With hypertension(≥140/90mmHg).
✕. Fasting C-peptide \<300pmol/L.
✕. Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, wearing insulin pumps, etc.

What they're measuring

Participants' personal information

Timeframe: 1 day

Physical assessments

Timeframe: 1 day

renal function

Timeframe: 1 day

renal magnetic resonance imaging(MRI)

Timeframe: 1 day

Trial details

NCT IDNCT06222476

SponsorYan Bi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Diabetic Nephropathy Type 2 trials