AIMS: To assess the non-inferiority of MYL-1501D, a proposed biosimilar or follow-on biological agent to marketed insulin glargine, to reference insulin glargine (Lantus®; Sanofi-Aventis US LLC, Bridgewater, New Jersey) based on change in glycated hemoglobin (HbA1c). MATERIALS AND METHODS: INSTRIDE 2 was a multicentre, open-label, randomized, parallel-group, phase III non-inferiority study comparing the efficacy and safety of MYL-1501D with those of reference insulin glargine in insulin-naive and insulin-non-naive patients with type 2 diabetes mellitus receiving oral antidiabetic drugs (OADs). The primary efficacy endpoint was change in HbA1c from baseline to week 24. Secondary endpoints included metabolic readouts (eg, changes in fasting plasma glucose, insulin dosage, self-monitored blood glucose), immunogenicity and adverse events, including hypoglycaemia and nocturnal hypoglycaemic events. RESULTS: In all, 560 patients were randomized to MYL-1501D or insulin glargine in combination with OADs for 24 weeks. The mean change in HbA1c from baseline to week 24 was -0.60% (95% CI -0.78, -0.41) and - 0.66% (95% CI -0.84, -0.48) for MYL-1501D and reference insulin glargine, respectively. MYL-1501D was well tolerated and had a safety profile similar to that of reference insulin glargine. CONCLUSIONS: Demonstration of non-inferiority between MYL-1501D and reference insulin glargine for reduction of HbA1c during 24 weeks of treatment was achieved. The two treatment groups were similar in terms of secondary endpoints, including hypoglycaemia and nocturnal hypoglycaemia, local and systemic reactions, other safety variables, and immunogenicity.
RCT Entities:
AIMS: To assess the non-inferiority of MYL-1501D, a proposed biosimilar or follow-on biological agent to marketed insulinglargine, to reference insulinglargine (Lantus®; Sanofi-Aventis US LLC, Bridgewater, New Jersey) based on change in glycated hemoglobin (HbA1c). MATERIALS AND METHODS: INSTRIDE 2 was a multicentre, open-label, randomized, parallel-group, phase III non-inferiority study comparing the efficacy and safety of MYL-1501D with those of reference insulinglargine in insulin-naive and insulin-non-naive patients with type 2 diabetes mellitus receiving oral antidiabetic drugs (OADs). The primary efficacy endpoint was change in HbA1c from baseline to week 24. Secondary endpoints included metabolic readouts (eg, changes in fasting plasma glucose, insulin dosage, self-monitored blood glucose), immunogenicity and adverse events, including hypoglycaemia and nocturnal hypoglycaemic events. RESULTS: In all, 560 patients were randomized to MYL-1501D or insulinglargine in combination with OADs for 24 weeks. The mean change in HbA1c from baseline to week 24 was -0.60% (95% CI -0.78, -0.41) and - 0.66% (95% CI -0.84, -0.48) for MYL-1501D and reference insulinglargine, respectively. MYL-1501D was well tolerated and had a safety profile similar to that of reference insulinglargine. CONCLUSIONS: Demonstration of non-inferiority between MYL-1501D and reference insulinglargine for reduction of HbA1c during 24 weeks of treatment was achieved. The two treatment groups were similar in terms of secondary endpoints, including hypoglycaemia and nocturnal hypoglycaemia, local and systemic reactions, other safety variables, and immunogenicity.
Authors: Thomas C Blevins; Abhijit Barve; Yaron Raiter; Patrick Aubonnet; Sandeep Athalye; Bin Sun; Rafael Muniz Journal: Diabetes Obes Metab Date: 2019-12-04 Impact factor: 6.577
Authors: Brian Godman; Magdalene Wladysiuk; Stuart McTaggart; Amanj Kurdi; Eleonora Allocati; Mihajlo Jakovljevic; Francis Kalemeera; Iris Hoxha; Anna Nachtnebel; Robert Sauermann; Manfred Hinteregger; Vanda Marković-Peković; Biljana Tubic; Guenka Petrova; Konstantin Tachkov; Juraj Slabý; Radka Nejezchlebova; Iva Selke Krulichová; Ott Laius; Gisbert Selke; Irene Langner; András Harsanyi; András Inotai; Arianit Jakupi; Svens Henkuzens; Kristina Garuolienė; Jolanta Gulbinovič; Patricia Vella Bonanno; Jakub Rutkowski; Skule Ingeberg; Øyvind Melien; Ileana Mardare; Jurij Fürst; Sean MacBride-Stewart; Carol Holmes; Caridad Pontes; Corinne Zara; Marta Turu Pedrola; Mikael Hoffmann; Vasileios Kourafalos; Alice Pisana; Rita Banzi; Stephen Campbell; Bjorn Wettermark Journal: Biomed Res Int Date: 2021-10-11 Impact factor: 3.411