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A 12-months multi-national, multi-centre, double-blind, randomised, parallel safety and efficacy comparison of insulin detemir produced by the current process and insulin detemir produced by the NN729...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-004733-15

A 12-months multi-national, multi-centre, double-blind, randomised, parallel safety and efficacy comparison of insulin detemir produced by the current process and insulin detemir produced by the NN729 process in subjects with type 1 diabetes on a basal-bolus regimen with insulin aspart as the bolus insulin

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Extrait

The primary objective of the trial is to compare the safety of insulin detemir produced by the NN729 process with insulin detemir produced by the current process (NN304), as measured by development of insulin cross-reacting antibodies, in subjects with type 1 diabetes during 12 months of treatment on a basal-bolus regimen with insulin detemir as basal insulin and insulin aspart as bolus.

Critère d'inclusion

  • type -I diabetes

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