Efficacy and safety of MYL‐1501D versus insulin glargine in people with type 1 diabetes mellitus: Results of the INSTRIDE 3 phase 3 switch study

Abstract

Aims To assess the efficacy, insulin dose, safety and immunogenicity when people with type 1 diabetes mellitus switched between MYL‐1501D and reference insulin glargine (Lantus®; Sanofi‐Aventis US LLC, Bridgewater, New Jersey). Materials and methods Eligible participants from INSTRIDE 1 who completed 52 weeks of reference insulin glargine treatment were randomized 1:1 to the reference sequence (n = 63; reference insulin glargine for 36 weeks) or to the treatment‐switching sequence (n = 64; MYL‐1501D [weeks 0–12], reference insulin glargine [weeks 12–24] and MYL‐1501D [weeks 24–36]). Change in glycated haemoglobin (HbA1c) from baseline to week 36 was the primary efficacy endpoint used to demonstrate equivalence between the two treatment sequences. Secondary endpoints included: change in fasting plasma glucose (FPG), self‐monitored blood glucose (SMBG) and insulin dose; immunogenicity; and adverse events, including hypoglycaemia. Results Mean changes in HbA1c (least squares [LS] mean [SE]) from baseline to week 36 were −0.05 (0.032) and −0.06 (0.034) for the treatment‐switching and reference sequences, respectively (LS mean difference 0.01 [95% CI −0.085 to 0.101]). Treatment sequences were comparable in terms of secondary endpoints, including FPG, SMBG and insulin dose, and the safety and immunogenicity profiles of the two sequences were similar. Conclusions Switching participants between MYL‐1501D and reference insulin glargine demonstrated equivalent efficacy and similar safety and immunogenicity, showing that people taking reference insulin glargine can safely switch to MYL‐1501D.

Pharmacokinetic and pharmacodynamic bioequivalence of proposed biosimilar MYL‐1501D with US and European insulin glargine formulations in patients with type 1 diabetes mellitus

“…Overall, all three study drugs were well tolerated, and no significant safety issues arose. Results from this study provide further support that the proposed IG biosimilar MYL‐1501D may be appropriate for clinical use in patients with T1DM, as indicated by phase 3 studies …”

“…Results from this study provide further support that the proposed IG biosimilar MYL-1501D may be appropriate for clinical use in patients with T1DM, as indicated by phase 3 studies. 25,27…”

MYL1501D Insulin Glargine: A Review in Diabetes Mellitus

“…Similar to that of reference insulin glargine 100 U/mL in patients with type 1 and 2 diabetes [10,11] and in those switching between the two treatments [12] Efficacy and safety (in reference trials)…”

“…Noninferior glycaemic efficacy and a similar safety profile in patients with type 1 or 2 diabetes [10,11] Switching between MYL1501D insulin glargine and reference insulin glargine 100 U/mL resulted in equivalent glycaemic efficacy [12] (insulin-naïve patients) or < 10.5% (insulin-experienced patients) and had received a stable oral antidiabetic drug (OAD) dosage for the previous ≥ 3 months [11]. Patients in INSTRIDE 1, and those in INSTRIDE 2 who were not insulin-naïve had received reference insulin glargine 100 U/ mL once daily for the previous ≥ 3 months [10,11].…”

“…Patients who completed 52 weeks' therapy with reference insulin glargine 100 U/mL in INSTRIDE 1 were eligible to enter an open-label, multinational, phase III switching study (INSTRIDE 3) [12]. In this study, patients were randomized to two treatment sequence groups:…”