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Dorzagliatin for Renal Function in T2DM with Early Kidney Injury
NCT06222476Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Feb 2024
- Primary completion
- May 2025
- Countries
- 1
- Sponsor
- Yan Bi
- Modality
- Small Molecules
- Drugs
- dorzagliatin
- Conditions
- type 2 diabetes mellitus (T2DM)diabetic nephropathy (DN)
01
Overview
Phase 4, randomised trial of dorzagliatin in type 2 diabetes mellitus (T2DM) and diabetic nephropathy (DN) (2 arms), sponsored by Yan Bi. Primary endpoints: Renal function (eGFR, creatinine, cystatin C, TNF-1) at 1 day and Renal magnetic resonance imaging (MRI) at 1 day. Planned start Feb 2024; status: not yet recruiting.
02
Design
2 arms- Study design
- Randomized
Dorzagliatin Arm
Dorzagliatin 75mg BID + Metformin 500mg TID
Gliclazide Arm
Gliclazide 30mg QD + Metformin 500mg TID
03
Who it enrols
Patients with Type 2 Diabetes Mellitus and early kidney injury (UACR 30-299mg/g, eGFR >= 60) on Metformin.
04
Endpoints
Primary
Renal function (eGFR, creatinine, cystatin C, TNF-1)
Renal magnetic resonance imaging (MRI)
Secondary
Blood sugar
Insulin
HOMA2-beta
HOMA2-IR
HOMA2-IS
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