Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this
trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in
subjects with type 2 diabetes never treated with insulin followed by the extension trial
investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin
glargine in subjects with type 2 diabetes.
All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant
enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl
peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment
is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor
treatment is also discontinued). Subjects who consent to participate in the extension trial
will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to
which they were randomly allocated in the 52 week main trial.
The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension
period is registered as NN1250-3643.