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Aim: To compare the clinical efficacy and safety of glargine‐U100 (Lantus/Gla‐100) with glargine‐U300 (Toujeo/Gla‐300) in adult patients with type 2 diabetes (T2D) and type 1 diabetes (T1D). Materials and Methods: A literature search on Gla‐300/Gla‐100 in diabetes management was conducted using the MEDLINE/Embase/Cochrane databases from inception to 10 January 2021. Eligible studies considered for inclusion were parallel‐design, randomized controlled trials (RCTs). The Cochrane risk‐of‐bias tool was used to evaluate the quality of the included studies. The random‐effects model was applied for interpretation of the results. Results: Of 5348 records screened, 592 were assessed for eligibility and 15 RCTs were considered for data extraction and meta‐analysis (T2D [N = 10; n = 7082]; T1D [N = 5; n = 2222]). In patients with T1D, all safety parameters were comparable between Gla‐100 and Gla‐300. In T2D, statistically significant differences were observed in favour of Gla‐300 over Gla‐100 for nocturnal and total hypoglycaemia. For efficacy parameters, a statistically and clinically significant difference favouring Gla‐100 in basal insulin dose requirement was observed for both T2D and T1D. Change in HbA1c showed a statistically but not clinically significant reduction with Gla‐100 compared with Gla‐300 in T1D. Statistically significant but clinically less relevant differences favoured Gla‐300 for control of body weight in T1D and T2D and Gla‐100 for fasting blood glucose in T2D. Conclusions: Gla‐100 and Gla‐300 had comparable efficacy and safety profiles in both T1D and T2D populations. Gla‐300 showed a lower risk of nocturnal and total hypoglycaemia, significant in insulin‐experienced/exposed patients with T2D. Patients on Gla‐300 required significantly more units of insulin daily than the Gla‐100 group to achieve equivalent efficacy. [ABSTRACT FROM AUTHOR]

Aim: To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Insulin N (Biocon's Insulin‐N; Biocon Biologics Ltd., Bangalore, India) and US‐licensed Humulin® N (Humulin‐N; Eli Lilly and Company, Indianapolis, IN, USA) in healthy subjects. Materials and Methods: This was a phase‐1, single‐centre, double‐blind, randomized, three‐period, six‐sequence, partially replicated, crossover, 24‐h euglycaemic clamp study. Overall, 90 healthy subjects were randomized, of whom 85 completed the study. The subjects received either two single doses of Biocon's Insulin‐N and a single dose of Humulin‐N or two single doses of Humulin‐N and a single dose of Biocon's Insulin‐N subcutaneously at a dose of 0.4 IU/kg. The primary PK endpoints were the area under the insulin concentration‐time curve from 0 to 24 h (AUCins.0‐24h) and the maximum insulin concentration (Cins.max). The primary PD endpoints were the area under the glucose infusion rate (GIR) curve from 0 to 24 h (AUCGIR.0‐24h) and the maximum GIR (GIRmax). Results: Biocon's Insulin‐N was found to be equivalent to Humulin‐N for the primary PK (geometric 90% confidence interval for the least squares mean ratio: AUCins.0‐24h, 100.98%‐115.66% and Cins.max, 95.91%‐110.16%) and PD endpoints (intra‐subject variability ≥0.294; 95% upper confidence interval [(μT – μR)2 − θσ2WR] <0; point estimates of geometric least squares mean ratio: AUCGIR.0‐24h, 104.61% and GIRmax, 100.81%). The safety profile of Biocon's Insulin‐N was similar to that of Humulin‐N, and no serious adverse events were reported. Conclusion: PK and PD equivalence was shown between Biocon's Insulin‐N and Humulin‐N in healthy subjects, and both treatments were well tolerated and considered safe. [ABSTRACT FROM AUTHOR]

Aim: To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar insulin 70/30 (Biocon's Insulin‐70/30) and HUMULIN® 70/30 (HUMULIN‐70/30; Eli Lilly and Company, IN). Materials and Methods: In this phase 1, automated euglycaemic glucose clamp study, 78 healthy subjects were randomized (1:1) to receive a single dose of 0.4 IU/kg of Biocon's Insulin‐70/30 and HUMULIN‐70/30. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 24 hours. Primary PK endpoints were area under the insulin concentration‐time curve from 0 to 24 hours ‐ AUCins.0−24h ‐ and maximum insulin concentration ‐ Cins.max. Primary PD endpoints were area under the GIR time curve from 0 to 24 hours ‐ AUCGIR.0−24h ‐ and maximum GIR ‐ GIRmax. Results: Equivalence was shown between Biocon's Insulin‐70/30 and HUMULIN‐70/30 for the primary PK/PD endpoints. The 90% confidence intervals of the treatment ratios were entirely within the acceptance range of 80.00%‐125.00%. The secondary PK/PD profiles were also comparable. There were no clinically relevant differences in the safety profiles of the two treatments and no serious adverse events were reported. Conclusion: PK/PD equivalence was demonstrated between Biocon's Insulin‐70/30 and HUMULIN‐70/30 in healthy subjects. Treatment with Biocon's Insulin‐70/30 and HUMULIN‐70/30 was well tolerated. [ABSTRACT FROM AUTHOR]

Aim: To establish equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) endpoints between proposed biosimilar Insulin‐R (Biocon's Insulin‐R) and Humulin® R using the euglycaemic clamp technique in healthy subjects. Materials and Methods: In this phase‐1 automated euglycaemic glucose clamp study, 42 healthy subjects were randomized (1:1) to receive a single dose of 0.3 IU/kg of Biocon's Insulin‐R and Humulin‐R. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 12 hours. Primary PK endpoints were area under the insulin concentration‐time curve from 0 to 12 hours (AUCins.0‐12h) and maximum insulin concentration (Cins.max). Primary PD endpoints were area under the GIR time curve from 0 to 12 hours (AUCGIR.0‐12h) and maximum GIR (GIRmax). Results: Equivalence was demonstrated between Biocon's Insulin‐R and Humulin‐R for the primary PK and PD endpoints. The 90% confidence intervals were within 80.00% to 125.00% limits. The PK and PD profiles were comparable. There were no significant differences in the safety profiles of the two treatments, and no serious adverse events were reported. Conclusion: PK and PD equivalence was demonstrated between Biocon's Insulin‐R and Humulin‐R in healthy subjects. Treatment with Biocon's Insulin‐R and Humulin‐R was well tolerated. [ABSTRACT FROM AUTHOR]