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

Diabetic Nephropathy Type 2 Clinical Trial

Official title:

A Multicentric, Prospective, Randomized Study Evaluating the Improvement of Renal Function Outcomes With Dorzagliatin in Patients With Type 2 Diabetes Mellitus With Early Kidney Injury.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06222476
• Other study ID #: BY2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

As soon，metformin、SGLT-2i、GLP-1RA have been confirmed to have protective effect on the kidneys in the statement of consensus at home and abroad. Dorzagliatin exerts a potent hypoglycemic effect by activating glucokinase and is not affected by the patient's renal function. However, previous studies of this drug have rarely involved studies that improve markers related to renal function. On the one hand, in this study, changes of renal function (eGFR, creatinine, cystatin C, TNF-1) are collected to investigate whether dorzagliatin is benefit to kidney. On the other hand, renal magnetic resonance imaging(MRI) results are analysed to explore the differences among control subjects and patients treated with dorzagliatin.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: June 30, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age:18-75 years old, male and female.

2. 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).

3. UACR 30-299mg/g.

4. eGFR =60mL/min/1.73m².

5. HbA1c 7.0-10.5%.

Exclusion Criteria:

1. Pregnant and lactating women and women of childbearing age who do not want to take reliable contraceptive measures.

2. Known allergic history to dorzagliatin/gliclazide/metformin.

3. Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or hypoglycemic coma, etc.

4. Serious impairment of heart, liver, kidney and other organs.

5. With hypertension(=140/90mmHg).

6. Fasting C-peptide <300pmol/L.

7. Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, wearing insulin pumps, etc.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy Type 2

Intervention

Drug:
• Dorzagliatin
Dorzagliatin will be initiated and maintained at 75mg twice a day
• Gliclazide
Gliclazide will be initiated and maintained at 30mg once a day

Locations

Country	Name	City	State
China	Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yan Bi

Country where clinical trial is conducted

China, 

References & Publications (5)

Hishida A, Takashima N, Turin TC, Kawai S, Wakai K, Hamajima N, Hosono S, Nishida Y, Suzuki S, Nakahata N, Mikami H, Ohnaka K, Matsui D, Katsuura-Kamano S, Kubo M, Tanaka H, Kita Y. GCK, GCKR polymorphisms and risk of chronic kidney disease in Japanese individuals: data from the J-MICC Study. J Nephrol. 2014 Apr;27(2):143-9. doi: 10.1007/s40620-013-0025-0. Epub 2013 Dec 17. — View Citation

Lin L, Dekkers IA, Huang L, Tao Q, Paiman EHM, Bizino MB, Jazet IM, Lamb HJ. Renal sinus fat volume in type 2 diabetes mellitus is associated with glycated hemoglobin and metabolic risk factors. J Diabetes Complications. 2021 Sep;35(9):107973. doi: 10.1016/j.jdiacomp.2021.107973. Epub 2021 Jun 15. — View Citation

Simons PIHG, Simons N, Stehouwer CDA, Schalkwijk CG, Schaper NC, Brouwers MCGJ. Association of common gene variants in glucokinase regulatory protein with cardiorenal disease: A systematic review and meta-analysis. PLoS One. 2018 Oct 23;13(10):e0206174. doi: 10.1371/journal.pone.0206174. eCollection 2018. — View Citation

Wang K, Shi M, Yang A, Fan B, Tam CHT, Lau E, Luk AOY, Kong APS, Ma RCW, Chan JCN, Chow E. GCKR and GCK polymorphisms are associated with increased risk of end-stage kidney disease in Chinese patients with type 2 diabetes: The Hong Kong Diabetes Register (1995-2019). Diabetes Res Clin Pract. 2022 Nov;193:110118. doi: 10.1016/j.diabres.2022.110118. Epub 2022 Oct 13. — View Citation

Yang W, Zhu D, Gan S, Dong X, Su J, Li W, Jiang H, Zhao W, Yao M, Song W, Lu Y, Zhang X, Li H, Wang G, Qiu W, Yuan G, Ma J, Li W, Li Z, Wang X, Zeng J, Yang Z, Liu J, Liang Y, Lu S, Zhang H, Liu H, Liu P, Fan K, Jiang X, Li Y, Su Q, Ning T, Tan H, An Z, Jiang Z, Liu L, Zhou Z, Zhang Q, Li X, Shan Z, Xue Y, Mao H, Shi L, Ye S, Zhang X, Sun J, Li P, Yang T, Li F, Lin J, Zhang Z, Zhao Y, Li R, Guo X, Yao Q, Lu W, Qu S, Li H, Tan L, Wang W, Yao Y, Chen D, Li Y, Gao J, Hu W, Fei X, Wu T, Dong S, Jin W, Li C, Zhao D, Feng B, Zhao Y, Zhang Y, Li X, Chen L. Dorzagliatin add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial. Nat Med. 2022 May;28(5):974-981. doi: 10.1038/s41591-022-01803-5. Epub 2022 May 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' personal information	Self-reported information (age in years, gender,course of disease )	1 day
Primary	Physical assessments	BMI (body mass index) in kg/m^2	1 day
Primary	renal function	changes of renal function (eGFR, creatinine, cystatin C, TNF-1)	1 day
Primary	renal magnetic resonance imaging(MRI)	Changes of perirenal fat content, renal proton density fat fraction and degree of renal fibrosis	1 day
Secondary	blood sugar	fasting blood sugar?2-hour postprandial blood sugar	1 day
Secondary	insulin	fasting insulin?2-hour insulin	1 day
Secondary	HOMA2-ß	20*fasting insulin(mIU/L)/(fasting blood sugar(mmol/L)-3.5)	1 day
Secondary	HOMA2-IR	fasting blood sugar(mmol/L)*fasting insulin(mIU/L)/22.5	1 day
Secondary	HOMA2-IS	22.5/fasting blood sugar(mmol/L)*fasting insulin(mIU/L)	1 day