OBJECTIVE
To evaluate the efficacy and safety of Cortexin in the comprehensive treatment of neurological complications in patients with type 2 diabetes mellitus (T2DM).
MATERIAL AND METHODS
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN). Of the participants, 70.6% were females and 29.4% were males, aged 45 to 70 years (mean age: 60.8±0.71 years). All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days—administered parenterally for the first 10 days and orally for the subsequent 20 days. The patients were followed up until Day 90. Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment. Changes in symptoms, glycemic hemoglobin (HbA1c) levels, cognitive deficit scores (Montreal Cognitive Assessment, MoCA), anxiety-depressive disorders (Hospital Anxiety and Depression Scale, HADS), and symptoms related to painless DPN (Neuropathy Symptom Score-9, Central Sensitization Index, CSI) were evaluated. The patients’ condition and response to therapy were objectively assessed using the Clinical Global Impression (CGI) scale, and adverse events (AEs) were documented.
RESULTS
The regression of cognitive symptoms in group 1 patients was superior to that in group 2 (6.0 times vs. 1.7 times), as confirmed by a 1.2-fold increase in the average MoCA score after 3 months of follow-up (p<0.001). In the Cortexin group, the mean HADS anxiety score decreased by 1.6 times, and the mean depression score decreased by 1.7 times, with minimal changes noted in the control group (p<0.001). Significant reductions in numbness were observed, with a 2.2-fold decrease in the Cortexin group compared to a 1.3-fold decrease in the control group. The mean NTSS-9 score dropped by 2.8 times in group 1 and by 1.3 times in group 2 (p<0.001); while the CSI decreased 1.8 times and 1.2 times, respectively (p<0.001). The reduction in HbA1c was also more significant in the Cortexin group (7.3±0.1% vs 7.8±0.1%, p<0.001). According to the CGI scale, 83.3% of patients in group 1 showed good or very good improvement, and a significant therapeutic effect was noted in 55.6% of patients. The proposed therapy demonstrated a high safety profile, with only 5 AEs reported (3 in Group 1 and 2 in Group 2), none of which were related to the study therapy.
CONCLUSION
The comprehensive therapy with Cortexin proved to be highly effective, safe, and well-tolerated in patients with neurological complications of T2DM, and it is recommended for use in general clinical practice.
