Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

Phase 3 Completed 753 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.

Timeline

Start: 1997-09
Primary completion: 2000-05
Completion: 2000-05

Publications

Results Home PD, Hallgren P, Usadel KH, Sane T, Faber J, Grill V, Friberg HH. Pre-meal insulin aspart compared with pre-meal soluble human insulin in type 1 diabetes. Diabetes Res Clin Pract. 2006 Feb;71(2):131-9. doi: 10.1016/j.diabres.2005.05.015. Epub 2005 Jul 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	human soluble insulin	Protein / enzyme biologic	—	Subcutaneous
Subject	insulin aspart	Protein / enzyme biologic	—	Subcutaneous
Background	insulin NPH	Protein / enzyme biologic	—	Subcutaneous

Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

Summary

Timeline

Publications

Drugs

Indications