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

NCT ID: NCT06222476

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2026-06-30

Brief 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.

Detailed 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.

Conditions

Diabetic Nephropathy Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patients treat with Dorzagliatin

Dorzagliatin will be initiated and maintained at 75mg twice a day until the completion of the study. Meanwhile, all patients will also continue on regimen of metformin 500mg three times a day throughout the study. Visits at 4-week intervals will be performed to evaluate the safety of drugs.

Group Type: EXPERIMENTAL

Dorzagliatin

Intervention Type: DRUG

Dorzagliatin will be initiated and maintained at 75mg twice a day

Patients treat with Gliclazide

Gliclazide will be initiated and maintained at 30mg once a day until the completion of the study. Meanwhile, all patients will also continue on regimen of metformin 500mg three times a day throughout the study. Visits at 4-week intervals will be performed to evaluate the safety of drugs.

Group Type: ACTIVE_COMPARATOR

Gliclazide

Intervention Type: DRUG

Gliclazide will be initiated and maintained at 30mg once a day

Interventions

Dorzagliatin

Dorzagliatin will be initiated and maintained at 75mg twice a day

Intervention Type: DRUG

Gliclazide

Gliclazide will be initiated and maintained at 30mg once a day

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yan Bi

OTHER

Sponsor Role: lead

Responsible Party

Yan Bi

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 35551292 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

BY2023

Identifier Type: -

Identifier Source: org_study_id