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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYan Bi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dorzagliatin

    Drug

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

  • Gliclazide

    Drug

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

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Patients treat with DorzagliatinExperimental treatment 1 intervention
Group B: Patients treat with GliclazideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Participants' personal information

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

Time frame
1 day
2

Physical assessments

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

Time frame
1 day
3

renal function

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

Time frame
1 day
4

renal magnetic resonance imaging(MRI)

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

Time frame
1 day

Secondary outcomes

1

blood sugar

fasting blood sugar、2-hour postprandial blood sugar

Time frame
1 day
2

insulin

fasting insulin、2-hour insulin

Time frame
1 day
3

HOMA2-β

20\*fasting insulin(mIU/L)/(fasting blood sugar(mmol/L)-3.5)

Time frame
1 day
4

HOMA2-IR

fasting blood sugar(mmol/L)\*fasting insulin(mIU/L)/22.5

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yan Bi

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor institution

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