Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
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.