NCT06222476

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Feb 2024Jun 2026

First Submitted

Initial submission to the registry

January 16, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

January 16, 2024

Last Update Submit

January 16, 2024

Conditions

Diabetic Nephropathy Type 2

Outcome Measures

Primary Outcomes (4)

  • Participants' personal information

    Self-reported information (age in years, gender，course of disease )

    1 day

  • Physical assessments

    BMI (body mass index) in kg/m\^2

    1 day

  • renal function

    changes of renal function (eGFR, creatinine, cystatin C, TNF-1)

    1 day

  • renal magnetic resonance imaging(MRI)

    Changes of perirenal fat content, renal proton density fat fraction and degree of renal fibrosis

    1 day

Secondary Outcomes (5)

  • blood sugar

    1 day

  • insulin

    1 day

  • HOMA2-β

    1 day

  • HOMA2-IR

    1 day

  • HOMA2-IS

    1 day

Study Arms (2)

Patients treat with Dorzagliatin

EXPERIMENTAL

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.

Drug: Dorzagliatin

Patients treat with Gliclazide

ACTIVE COMPARATOR

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.

Drug: Gliclazide

Interventions

DorzagliatinDRUG

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

Patients treat with Dorzagliatin
GliclazideDRUG

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

Patients treat with Gliclazide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

Related Publications (5)

  • 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.

    PMID: 35551292BACKGROUND

  • 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.

    PMID: 30352097BACKGROUND

  • 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.

    PMID: 24535998BACKGROUND

  • 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.

    PMID: 36243233BACKGROUND

  • 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.

    PMID: 34217586BACKGROUND

MeSH Terms

Interventions

DorzagliatinGliclazide

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfonylurea CompoundsUreaBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 24, 2024

Study Start

February 20, 2024

Primary Completion

May 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations

CN(1)