A randomised, double blind, cross-over trial comparing the safety and efficacy of insulin degludec and insulin glargine, both with insulin aspart as mealtime insulin in subjects with type 1 diabetes
The overall purpose of this trial is to evaluate the hypoglycaemia profile of IDeg in subjects with T1DM currently treated with basal-bolus insulin therapy. Primary Objective: To compare the rates of severe or blood glucose confirmed symptomatic hypoglycaemia of IDeg once daily + IAsp to IGlar OD + IAsp, by demonstrating that the upper limit of the 95 percent confidence interval of the ratio is below or equal to a non-inferiority margin of 1.10, and if confirmed to a superiority limit of 1.0.
Keywordsinsulin, glargine, degludec, type 1 diabetes, hypoglycaemia
Principal InvestigatorMae Sheikh-Ali
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