Meta-analysis of the efficacy and safety of insulin Icodec in the treatment of type 2 diabetes mellitus.

Objective To systematically evaluate the efficacy and safety of insulin Icodec in the treatment of type 2 diabetes mellitus (T2DM) in order to provide evidence-based guidance for the rational clinical use of drug. Methods The databases of PubMed, Embase, Cochrane Library, Web of Science, Sinomed, CNKI, Wanfang and VIP were searched by computer to identify randomized controlled trials (RCT) comparing the efficacy and safety of insulin Icodec (trial group) versus placebo or other hypoglycemic agents (control group) in the treatment of T2DM were collected from the date of database inception to August 2023. The efficacy indexes included: glycated hemoglobin A1c (HbA1c) level, HbA1c compliance rate (HbA1c<7%), fasting plasma glucose (FPG) level, body weight level, time in range (TIR) percentage. Safety indicators included: incidence of hypoglycemia events, incidence of injection site reactions, incidence of drug allergic reactions, and incidence of serious adverse events. Two evaluators independently screened the literature, extracted data from the literature and assessed the risk of bias of the studies included, and performed a meta-analysis of the data using RevMan 5.4 software. Results Seven studies with a total of 3 286 patients were included. The results of meta-analysis showed that compared with the control group, insulin Icodec reduced HbA_1c (WMD=-0.16%, 95%CI -0.26%-0.07%, P<0.01), increased the rate of HbA_1c compliance (OR=1.50, 95%CI 1.29-1.74, and decreased HbA1c compliance (WMD=-0.16%, 95%CI -0.26%-0.07%, P<0.01). However, there was no statistically significant difference between the two groups in reducing FPG levels (WMD=-0.05 mmol/L, 95%CI -0.29-0.20 mmol/L, P=0.71), and it increased the body weight of patients (WMD=0.52 kg, 95%CI 0.22-0.82 kg, P<0.01), but increased the percentage of TIR in patients (WMD=5.86%, 95%CI 2.02%-9.70%, P=0.003). In terms of safety, although the incidence of hypoglycemic events (OR=1.37, 95%CI 1.17-1.61, P<0.01) was higher in the insulin Icodec group than in the control group, the incidence of anaphylaxis was higher in insulin Icodec group than in the control group (OR=0.91, 95%CI 0.64-1.31, P=0.62), injection site reaction (OR=1.03, 95%CI 0.63-1.66, P=0.92) and incidence of serious adverse events (OR=0.97, 95%CI 0.75-1.24, P=0.79), there was no significant difference between insulin Icodec and control groups. Conclusions Insulin Icodec can lower HbA1c levels in patients and increase the rate of HbA1c compliance without increasing the incidence of injection site reactions, allergic events and serious adverse events. [ABSTRACT FROM AUTHOR]