ACMS Bulletin, November 2021

Page 22

Materia Medica Perspective

Semglee® (Insulin Glargine) WILLIAM BEATHARD, PHARMD AND SAMANTHA DEMARCO, PHARMD, BCPS ackground: Semglee® (insulin glargine) 100 units/mL is a long-acting recombinant human insulin analog recently FDA approved for the treatment of Type 1 and Type 2 diabetes mellitus, June 11, 2020.1,2 Semglee®, similar to Basaglar FDA approved in 2014, is a biosimilar of insulin glargine that established appropriate physiochemical, pharmacodynamic, and pharmacokinetic bioequivalence with insulin glargine 100 U/mL.2 Clinical trials have demonstrated this once daily insulin glargine biosimilar exhibits noninferiority to insulin glargine with respect to long-term HbA1c reduction. This insulin analog was designed with market competition and cost mitigation in mind. Safety: As with other long-acting insulins, Semglee® is contraindicated during episodes of hypoglycemia.1 In 24 and 52-week clinical trials, non-severe treatment-related hypoglycemia was the most common adverse event however the incidence was comparable to insulin glargine with respect to both anytime and nocturnal hypoglycemia.3,4 Tolerability: Semglee® is approved for subcutaneous administration once daily at any time of the day, administered at the same time every day an reflects the tolerability of other FDA approved insulin glargine analogs.1 It carries a similar adverse

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effect profile as demonstrated in other insulin glargine trials. Aside from hypoglycemia, adverse effects occurring in > 10% of patients include upper respiratory tract infections, nasopharyngitis, peripheral edema, hypertension, influenza, sinusitis, and bronchitis.1,3,4 At a mean dose of 0.37 units/kg and ~0.3 units/kg in the 24 and 52-week studies respectively, the prevalence of adverse events was similar between groups.3,4 Weight gain and lipodystrophy are still shared among all insulin and insulin analogs.1 Treatment related discontinuation rates between Semglee® and insulin glargine were comparably low in both studies at 1.1%.3,4 Efficacy: In clinical trials, Semglee® has been shown to be non-inferior to reference insulin glargine with respect to mean change in HbA1c from baseline.1,3,4 Outcomes in HbA1c reduction in type 2 diabetics receiving oral antidiabetic agents were studied in the INSTRIDE 2 study, a 24-week, multicenter, open-label, randomized, parallel-group, phase III non-inferiority study.4 560 patients were randomized to receive Semglee® or insulin glargine at a predefined recommended starting dose of 10 units or 0.2 units/kg. The results of this trial demonstrated a mean change in HbA1c of -0.60% from baseline to week 24 compared to -0.66% seen with insulin glargine (mean in-between

group difference 0.06%; 95% CI -0.10, 0.22). Mean HbA1c was also the primary endpoint in the INSTRIDE 1 study, a 52-week, open-label, randomized, phase III study in type 1 diabetics.3 558 patients were randomized to receive either Semglee® or insulin glargine in combination with three times daily meantime insulin lispro. The results of this study revealed a mean change in HbA1c from baseline to week 24 of 0.14% in the Semglee® group and 0.11% in the insulin glargine group (mean in-between group difference -0.05%; SE 0.052, 95% CI -0.148, 0.057). Secondary clinical endpoints in both studies included changes in insulin dose, fasting plasma glucose (FBG), and self-monitored blood glucose (SMBG).3,4 The INSTRIDE 2 trial, a non-inferiority study, noted no significant differences in the mean FBG between the Semglee group versus the insulin group (-0.74mmol/L vs -1.05mmol/L, p = 0.071).4 Significant decreases in SMBG were observed similarly in both treatment groups, and the mean daily insulin dose significantly increased over the 24-week study period to 0.37 units/kg and 0.38 units/kg in the Semglee® and insulin glargine group respectively. The INSTRIDE 1 trial demonstrated similar results at the end of the 52-week study period with no


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