3 years ago

Single Dose Euglycemic Clamp Studies Demonstrating Pharmacokinetic and Pharmacodynamic Similarity Between MK-1293 Insulin Glargine and Originator Insulin Glargine (Lantus) in Type 1 Diabetes and Healthy Subjects

Chantal D. Mahon, Michael C. Marcos, Linda Morrow, Yang Xu, Kate M. Mostoller, John S. Palcza, Michael Crutchlow, Marcus Hompesch, Elaine Watkins, April M. Barbour
Aims MK-1293 is an insulin glargine that has an identical amino acid sequence to that of Lantus, the originator insulin glargine. Two euglycemic clamp studies, one in subjects with Type 1 diabetes (T1D) and one in healthy subjects, were conducted to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity between MK-1293 and Lantus commercially procured in both the European Union (EU-Lantus) and United States (US-Lantus). Materials and Methods Both studies were single-dose, randomized, double-blind, single-center, crossover studies with ≥7 days between dosing periods. A 2-treatment, 4-period replicate crossover study in T1D subjects (N=76) compared the PK and PD of MK-1293 to EU-Lantus for 30 hours after dosing. A 3-period crossover study in healthy subjects (N=109) compared the PK and PD of MK-1293, EU-Lantus, and US-Lantus for 24 hours after dosing. In both studies, all subjects received single 0.4 units/kg subcutaneous doses of MK-1293 or Lantus in all dosing periods. Pharmacokinetic assessment was based on LC-MS/MS-based measurement of the major insulin glargine metabolite (M1) and PD was characterized using the euglycemic clamp platform. Results In both studies, pre-specified similarity criteria were met between MK-1293 and Lantus for comparison of PK (AUC0-24hr and Cmax of M1) and PD (GIR-AUC0-24hr, GIR-AUC0-12hr, GIR-AUC12-24hr, and GIRmax) primary endpoints. All treatments were well tolerated. Conclusion Based on comparative assessment in both T1D and healthy subjects, it can be concluded that the PK and PD properties of MK-1293 are highly similar to those of Lantus. (ClinicalTrials.gov: NCT02059174)

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/dom.13084

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