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Efficacy of Biosimilar Insulin MK-1293 versus Originator Glargine
Conference Lecture with Philip D. Home / ADA 76th Scientific Sessions, New Orleans, June ‘16
Philip D. Home, MD, PhD, Newcastle Diabetes Centre and University of Newcastle, Newcastle, UK, presented results of a trial comparing biosimilar MK-1293 with the original insulin glargine at the 76th scientific session of the American Diabetes Association 2016 in New Orleans, US, June 10-14.
Efficacy of MK-1293
MK-1293 biosimilar insulin designed to be similar to his originator biological insulin glargine (IGlar, Lantus®). MK-1293 was tested in a clinical study with 506 patients with type I diabetes randomized to the new MK-1293 and insulin glargine.
Endpoints were HBA1c, hypoglycemia and fasting glucose. HBA1c declines similarly with no differences between the biosimilar and the originator. The confidence interval was equivalent and non-inferior. For the other measures - fasting glucose and hypoglycemia - no difference between MK-1293 and the original IGlar was observed.
Safety of MK-1293
With regard to adverse effects MK-1293 and the originator share similar profiles. Immunological events were very few and similar between MK-1293 and IGlar. No relationship could be discerned between the antibody titres and neutralizing antibodies in the population.
The pharmacological and pharmacokinetical studies comparing MK-1293 and IGlar in patients with type I diabetes demonstrated the same profile in terms of concentration and activity.
The therapeutic profile of MK-1293 and IGlar in patients with type I diabetes is the same. A similar result was obtained studying patients with type II diabetes.
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