At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-months Multi-national, Multi-centre, Double Blind, Randomised, Parallel Safety and Efficacy Comparison of Insulin Detemir Produced by the Current Process and Insulin Detemir Produced by the NN729 Process in Subjects With Type 1 Diabetes on a Basal-bolus Regimen With Insulin Aspart as the Bolus Insulin
In Brief
A Phase 3 clinical trial evaluating insulin detemir and insulin aspart for Diabetes and Diabetes Mellitus, Type 1. Completed, enrolled 330 participants across 5 sites in 5 countries.
Detailed Summary
The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.
Study Details
Timeline
Interventions
NN304 injected s.c. (under the skin). Given as basal insulin.
Injected s.c. (under the skin). Given as bolus insulin.
NN729 injected s.c. (under the skin). Given as basal insulin