Efficacy and safety of beinaglutide with continuous subcutaneous infusion in newly diagnosed patients with type 2 diabetes: a randomized, control, open-labeled clinical trial.

Purpose: To explore the efficacy and safety of continuous subcutaneous glucagon-like peptide-1 receptor agonist infusion (CSGI) combined with continuous subcutaneous insulin infusion (CSII) on body weight, glycemic control and β-cell function in newly diagnosed type 2 diabetes (T2D) patients.

Methods: From May 2018 to November 2021, 30 newly diagnosed T2D patients at Nanjing First Hospital were recruited then randomized 1:1 to receive either CSGI add-on to CSII or CSII for 4 weeks. The oral glucose tolerance test (OGTT) and 3-day continuous glucose monitoring (CGM) were performed at the baseline and endpoint. The primary outcome was body weight change from baseline to endpoint.

Results: After treatment for 4 weeks, the CSGI add-on group achieved greater weight reduction (- 8.8 ± 4.5 kg vs. 0.0 ± 1.8 kg; P < 0.001) and BMI decrease (3.0 ± 1.3 vs. 0.0 ± 0.7 kg/m²; P < 0.001) versus CSII alone, with 80% (vs. 0%) losing ≥ 5% body weight (P < 0.001). While glycemic control improved in both groups, the CSGI add-on group required lower insulin doses to maintain euglycemia and showed enhanced β-cell function (P < 0.05). No serious adverse events occurred.

Conclusions: Adding CSGI to CSII therapy significantly led to significant weight loss and glycemic control in new diagnosed T2D patients. This combined approach shows promise but needs more research.

Trial Registration Number: ChiCTR1800015914, registered on 28 April, 2018.