drugset / Trial / NCT01114542
A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes
RandomizedCrossoverDouble-blindTreatment
Summary
This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.
Timeline
- Start
- 2010-05-03
- Primary completion
- 2010-08-10
- Completion
- 2010-08-10
Publications
- Results Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016 Jan;8(1):132-8. doi: 10.1111/1753-0407.12266. Epub 2015 Mar 24.
- Results Heise T, Hovelmann U, Nosek L, Hermanski L, Bottcher SG, Haahr H. Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol. 2015;11(8):1193-201. doi: 10.1517/17425255.2015.1058779. Epub 2015 Jun 18.
- Results Heise T, Kaplan K, Haahr HL. Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Between Insulin Degludec and Insulin Glargine (100 U/mL and 300 U/mL): A Comparison Across Studies. J Diabetes Sci Technol. 2018 Mar;12(2):356-363. doi: 10.1177/1932296817731422. Epub 2017 Sep 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin degludec | Protein / enzyme biologic | 0.4 iu/kg | Subcutaneous |
| Subject | insulin degludec | Protein / enzyme biologic | 0.6 iu/kg | Subcutaneous |
| Subject | insulin degludec | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.4 iu/kg | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.6 iu/kg | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.8 iu/kg | Subcutaneous |