Basalog® is similar to Lantus® in producing glycemic control in patients with type 1 diabetes mellitus on multiple daily insulin regimens

Abstract

This study was performed to compare the insulin glargine produced by two different manufacturers. The study determines the efficacy and safety of a new insulin glargine (Basalog®) having the same amino-acid sequence as Lantus® in patients with type 1 diabetes mellitus on multiple daily insulin regimen. After a run-in period of 4 weeks on once-daily Lantus®, patients were randomized in 1:1 ratio to receive once-daily treatment with either Basalog® (n=107) or Lantus® (n=108) for 12 weeks in this open-label multicenter study. Patients were enrolled from 15 hospitals in India. Change in HbA1c was the primary efficacy parameter; FPG, 7-point glucose profile and PPG were the secondary efficacy parameters. Hypoglycemia and immunogenicity were the main safety parameters. This was a non-inferiority study where non-inferiority could be claimed if mean difference (including 95% CI) was less than or equal to 0.5% for the primary efficacy parameter

Biosimilar vs originator insulins: Systematic review and meta‐analysis

“…Six studies investigated type 1 diabetes and 4 studies investigated type 2 diabetes. The primary endpoint was assessed after 24 or 26 weeks, except in the study by Verma et al (12 weeks) . The mean age, fasting plasma glucose, HbA1c and body mass index were 41 to 62 years, 8.3 to 10.1 mmol/L, 7.4% to 8.4% (57 mmol/mol to 68 mmol/mol), and 25.5 to 32.2 kg/m 2 , respectively.…”

“…Odds ratio (OR) was used as a measure of effect for dichotomous variables. *This analysis included data from the trial by Verma et al, which had a duration of only 12 weeks. CI, confidence interval; HbA1c, glycated haemoglobin; WMD, weighted mean difference…”

Efficacy and Safety of Biosimilar Insulins Compared to Their Reference Products: A Systematic Review

“…The remaining 11 studies, all RCTs, met eligibility criteria and were included in the data synthesis [28][29][30][31][32][33][34][35][36][37][38]. Two open-label trials that studied LY2963016 and SAR342434 included an extension study that followed patients for up to 52 weeks to assess for immunogenicity and additional adverse events [33,35].…”

“…Five of the 11 trials assessed clinical efficacy (Table 2), with 3 studies enrolling type 1 diabetics and 2 studies enrolling type 2 diabetics [32][33][34][35]38]. These studies compared Basalog and LY2963016 to Lantus and SAR342434 to Humalog.…”

“…Five of the 11 trials [32][33][34][35]38] assessed immunogenicity (S5 Table). Participants consisted of patients with type 1 and type 2 diabetes.…”