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

Overview

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.

This is a prospective, randomized, active-controlled, multicenter clinical study designed to enroll 206 eligible patients with T2DM complicated by moderate to severe chronic renal insufficiency. Patients who pass screening will first enter a 2-week run-in period involving diet and exercise control and continuous glucose monitoring (CGM). Laboratory assessments and other relevant evaluations will be performed within 3 days prior to randomization. At the randomization visit, eligibility will be reconfirmed according to the inclusion and exclusion criteria. Qualified patients will then be randomly assigned through a random number system to receive either dorzagliatin tablets 75 mg BID or linagliptin tablets 5 mg QD. Both groups will receive study treatment on the basis of background antihyperglycemic therapy. Background antihyperglycemic therapy is defined as a stable glucose-lowering regimen used for at least 4 weeks prior to enrollment, consisting of basal insulin injection (excluding insulin-incretin combination preparations) and 0 to 2 oral antidiabetic drugs. Oral antidiabetic drugs are restricted to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors (AGIs), meglitinides, and thiazolidinediones (TZDs). After treatment initiation, basal insulin will be standardized to insulin glargine U300 in all patients. The treatment duration is 14 weeks. At the end of treatment, investigational medication will be discontinued, followed by a 1-week safety follow-up period.