Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes

Phase 3 Completed 131 enrolled Novo Nordisk A/S

RandomizedCrossoverOpen-labelTreatment

Summary

This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.

Timeline

Start: 2001-09
Primary completion: 2002-11
Completion: 2002-11

Outcome

Met primary endpoint

paper Risk of nocturnal and overall hypoglycaemia was, respectively, 50% and 18% lower with detemir than with NPH (P < 0.001). PMID 16842476 ↗

Publications

Results Kolendorf K, Ross GP, Pavlic-Renar I, Perriello G, Philotheou A, Jendle J, Gall MA, Heller SR. Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes. Diabet Med. 2006 Jul;23(7):729-35. doi: 10.1111/j.1464-5491.2006.01862.x.

Drugs

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