Comparative analysis of glycemic control effectiveness and microvascular complications in patients with type 1 diabetes mellitus, treated with genetically engineered human insulin or human insulin analogues: A 10-year retrospective observational study

The treatment of diabetes mellitus generally involves genetically engineered human insulin (GICH) or genetically engineered analogues of human insulin (AIC). Compared to GICH, AIC better physiologically mimics endogenous insulin functionally. It would thus be logical to assume that long-term (multi-year) application of AIC leads to a lower incidence of diabetic angiopathy compared to GICH. To date, however, no long-term comparisons of both classes of insulin preparations (in terms of efficacy of glycemic control or incidence of microvascular complications in patients with type 1 diabetes) have been performed. Aims. To retrospectively compare the efficacy of glycemic control and incidence of microvascular complications (nephropathy and retinopathy) in patients with type 1 diabetes treated for at least 10 years with either GICH or AIC. Materials and methods. Based on data from electronic databases (diabetes registry) from several regions within the Russian Federation, the following patient samples were examined (n=260): group 1 received GICH for 10 years (n = 130) and group 2 received AIC for 10 years (n = 130). Patients in both groups underwent pairwise matching for baseline clinical characteristics (sex, age of diabetes onset, duration of disease and HbA(1c) level). All patients were observed by endocrinologists in the clinic. Results. After 10 years of follow up, HbA1c levels declined more significantly in group 2 than in group 1 (1.30% vs. 0.81%, respectively, P < 0.05). By the end of the observation period, the presence of diabetic retinopathy (any stage) increased in both groups and was not significantly different between groups; the presence of diabetic nephropathy was also increased in both groups, but the increase was significantly lower in group 2 than in group 1 (20.5% vs. 33.9%, respectively, P < 0.05). Overall, the risk of microvascular complications was significantly higher in group 1 than in group 2 [HR (hazard ratio): 1.84; 95% CI: 1.37-2.48), specifically, the risk of diabetic retinopathy (HR: 1.37; 95% CI: 0.98-1.90). Conclusions. A 10-year retrospective analysis of patients treated with AIC for type 1 diabetes in the clinic showed a significantly more effective reduction in HbA1c levels and a lower incidence of diabetic nephropathy, compared with patients treated with GICH.