Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

Phase 1 Completed 28 enrolled Novo Nordisk A/S

RandomizedCrossoverDouble-blindTreatment

Summary

This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes. The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.

Timeline

Start: 2009-10
Primary completion: 2010-03
Completion: 2010-03

Outcome

Missed primary endpoint

paper No treatment differences in HSS (estimated difference: 0.17 [95% CI -1.71, 2.05]; p > 0.05) PMID 24057153 ↗

Publications

Results Koehler G, Heller S, Korsatko S, Roepstorff C, Rasmussen S, Haahr H, Pieber TR. Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a double-blind randomised crossover study. Diabetologia. 2014 Jan;57(1):40-9. doi: 10.1007/s00125-013-3056-0. Epub 2013 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin degludec	Protein / enzyme biologic	80 %	Subcutaneous
Subject	insulin glargine	Protein / enzyme biologic	80 %	Subcutaneous