Study on Improving Blood Glucose Homeostasis With Dorzagliatin Tablets in the Treatment of Type 2 Diabetes Mellitus Patients With Moderate to Severe Chronic Renal Insufficiency

NCT07786571 | Not Yet Recruiting

• 1 other identifier: IIT-2026-766
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether dorzagliatin can improve glycemic homeostasis in patients with type 2 diabetes mellitus (T2DM) complicated by chronic renal insufficiency, and to compare the efficacy of dorzagliatin with linagliptin in improving glycemic control in patients with T2DM and moderate to severe chronic renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<45 mL/min/1.73 m²). This is a prospective, randomized, active-controlled, multicenter clinical study planned to enroll 206 eligible patients. After successful screening, patients will enter a 2-week run-in period consisting of diet and exercise control together with continuous glucose monitoring (CGM). Eligible patients will then be randomized to receive dorzagliatin 75 mg twice daily (BID) or linagliptin 5 mg once daily (QD) on top of background antihyperglycemic therapy. Basal insulin therapy will be standardized to insulin glargine U300 after treatment initiation. The treatment period will last 14 weeks, followed by a 1-week safety follow-up period.

Conditions

Type 2 Diabetes Mellitus (T2DM); Chronic Renal Insufficiency; Chronic Kidney Disease (Stages 3b-5); Glucose Homeostasis

Keywords

Dorzagliatin; Linagliptin; Time in Range; Glycemic Homeostasis

Outcome Measures

Primary Outcomes (1)

• Change in Time in Range (TIR, 3.9-10.0 mmol/L) from baseline to Week 14

  To compare the change in TIR (3.9-10.0 mmol/L) from baseline to Week 14 between the dorzagliatin 75 mg BID group and the linagliptin 5 mg QD group in patients with T2DM complicated by moderate to severe chronic renal insufficiency.

  Baseline to Week 14

Secondary Outcomes (1)

• Change in HbA1c from baseline to Week 14

  Baseline to Week 14

Study Arms (2)

Dorzagliatin Group

EXPERIMENTAL

Dorzagliatin tablets, 75 mg BID

Drug: Dorzagliatin

Linagliptin Group

ACTIVE COMPARATOR

Linagliptin tablets, 5 mg QD

Drug: Linagliptin

Interventions

Dorzagliatin DRUG

insulin glargine U300 with 0-2 OAD

Dorzagliatin Group

Linagliptin DRUG

insulin glargine U300 with 0-2 OAD

Linagliptin Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years.
• Diagnosed with type 2 diabetes mellitus according to the 2026 American Diabetes Association (ADA) criteria or the 2024 Chinese Guidelines for the Prevention and Treatment of Diabetes.
• Diagnosed with chronic renal insufficiency, with eGFR \<45 mL/min/1.73 m² calculated using the Modification of Diet in Renal Disease (MDRD) equation, and not receiving maintenance dialysis.
• HbA1c between 7.0% and 9.0%.
• Receiving a stable antihyperglycemic treatment regimen for at least 4 weeks prior to enrollment. The regimen should include basal insulin injection (excluding insulin-incretin combination preparations) and 0 to 2 oral antidiabetic drugs. Oral antidiabetic drugs are limited to metformin, SGLT2 inhibitors, alpha-glucosidase inhibitors, meglitinides, and TZDs.
• Written informed consent provided.

You may not qualify if:

• Type 1 diabetes mellitus, latent autoimmune diabetes in adults (LADA), or other specific types of diabetes.
• Diabetic ketoacidosis or hyperosmolar hyperglycemic state within the past 3 months.
• Active liver disease (ALT/AST \>3 × ULN) or liver cirrhosis (Child-Pugh class B or above).
• Severe heart failure (NYHA class III-IV) or a history of acute coronary syndrome or stroke within the past 6 months.
• Malignancy or life expectancy \<6 months.
• Pregnant or lactating women, or women of childbearing potential not using effective contraception.
• Known allergy to dorzagliatin or any of its components.
• Known allergy to linagliptin or any of its components.
• Current participation in another interventional clinical trial.
• Mental illness or cognitive impairment preventing compliance with study follow-up.
• Severe gastrointestinal disease affecting drug absorption.
• Current use of strong CYP3A4 inducers (e.g., rifampicin) or inhibitors (e.g., ketoconazole) that cannot be discontinued.
• Severe hypertriglyceridemia (\>5.7 mmol/L).
• Dialysis for acute renal failure within 3 months before run-in, current dialysis, or need for/planned kidney transplantation within 12 months.
• Use of corticosteroids or immunosuppressants within the past 6 months.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

Dorzagliatin; Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Officials

• Yanbing Li

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Liu, Associate Professor

CONTACT

+86 18988992996; liujuan3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)