Search

Background and purpose: To compare the efficacy, safety, and immunogenicity of recombinant insulin aspart 100 U/mL manufactured by BioGenomics Limited (BGL-ASP) with innovator NovoRapid® in type 2 diabetes mellitus patients (T2 DM). Experimental approach: This was a multicenter, open-label, randomized, parallel-group study in T2 DM patients, on premix human insulin therapy ± oral anti-diabetics. Besides self-monitored plasma glucose, fasting and post-prandial plasma glucose (FPG and PPG) were tested at baseline, week 12, and week 24. Anti-insulin aspart antibodies measured immunogenicity at 12 and 24 weeks. Findings/Results: 160 patients out of 320 patients randomly received BGL-ASP and the remaining patients received NovoRapid®. The changes in glycated hemoglobin (HbA1c) from baseline to weeks 12 and 24 for the BGL-ASP group were -0.8 ± 0.83 and -0.8 ± 0.81, respectively, while for the NovoRapid®group was -0.8 ± 1.01 and -0.9 ± 0.89, respectively. Changes in FPG and PPG were comparable between the treatment groups after 12 weeks and 24 weeks. The incidence of detectable antibodies at baseline, weeks 12, and 24 were comparable between treatment groups. Eighteen (11.3%) patients in the BGL-ASP group and 23 (14.4%) in the NovoRapid®group reported adverse events. Conclusion and implications: BGL-ASP and NovoRapid®were comparable and equally effective in lowering HbA1c, FPG, and PPG levels, with similar immunogenicity and safety profiles.

Competing Interests: The authors declare no conflicts of interests related to this article, financial or otherwise.

Acute encephalitis syndrome (AES) in children poses a significant public health challenge in India. This study aims to explore the utility of host inflammatory mediators and neurofilament (NfL) levels in distinguishing etiologies, assessing disease severity, and predicting outcomes in AES. We assessed 12 mediators in serum (n = 58) and 11 in cerebrospinal fluid (CSF) (n = 42) from 62 children with AES due to scrub typhus, viral etiologies, and COVID-associated multisystem inflammatory syndrome (MIS-C) in Southern India. Additionally, NfL levels in serum (n = 20) and CSF (n = 18) were examined. Clinical data, including Glasgow coma scale (GCS) and Liverpool outcome scores, were recorded. Examining serum and CSF markers in the three AES etiology groups revealed notable distinctions, with scrub typhus differing significantly from viral and MIS-C causes. Viral causes had elevated serum CCL11 and CCL2 compared with scrub typhus, while MIS-C cases showed higher HGF levels than scrub typhus. However, CSF analysis showed a distinct pattern with the scrub typhus group exhibiting elevated levels of IL-1RA, IL-1β, and TNF compared with MIS-C, and lower CCL2 levels compared with the viral group. Modeling the characteristic features, we identified that age ≥3 years with serum CCL11 < 180 pg/mL effectively distinguished scrub typhus from other AES causes. Elevated serum CCL11, HGF, and IL-6:IL-10 ratio were associated with poor outcomes (p = 0.038, 0.005, 0.02). Positive CSF and serum NfL correlation, and negative GCS and serum NfL correlation were observed. Median NfL levels were higher in children with abnormal admission GCS and poor outcomes. Measuring immune mediators and brain injury markers in AES provides valuable diagnostic insights, with the potential to facilitate rapid diagnosis and prognosis. The correlation between CSF and serum NfL, along with distinctive serum cytokine profiles across various etiologies, indicates the adequacy of blood samples alone for assessment and monitoring. The association of elevated levels of CCL11, HGF, and an increased IL-6:IL-10 ratio with adverse outcomes suggests promising avenues for therapeutic exploration, warranting further investigation., (© 2024 Wiley Periodicals LLC.)