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

Sponsor
Sun Yat-sen University
Study ID
NCT07786571
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dorzagliatin — DRUG
    insulin glargine U300 with 0-2 OAD
  • Linagliptin — DRUG
    insulin glargine U300 with 0-2 OAD

Study Details

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.

Key Dates

First listed
Aug 26, 2026
Start date
Dec 1, 2026
Status verified
Aug 2026
Primary completion
Mar 1, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
206 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dorzagliatin Group
    Dorzagliatin tablets, 75 mg BID
  • Active Comparator: Linagliptin Group
    Linagliptin tablets, 5 mg QD

Primary Outcome Measure

Change in Time in Range (TIR, 3.9-10.0 mmol/L) from baseline to Week 14 [ Time Frame: Baseline to Week 14 ]

Central Contacts

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