Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
This trial is conducted in Europe, Oceania, and the United States of America (USA).

 The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart
 (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes
 (main period) followed by the extension period comparing the long-term safety of NN5401 plus
 insulin aspart with insulin detemir plus insulin aspart.

 The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension
 period is registered as NN5401-3645.
Inclusion Criteria:

 -  FOR THE MAIN TRIAL, NN5401-3594:

 -  Type 1 diabetes mellitus for at least 12 months

 -  Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin
 regimen, self mix regimen) for at least 12 months

 -  HbA1c 7.0-10.0% (both inclusive)

 -  BMI (Body Mass Index) below or equal to 35.0 kg/m^2

 -  FOR THE EXTENSION TRIAL, NN5401-3645:

 -  The subject must have completed the six-month treatment period in trial NN5401-3594

 Exclusion Criteria:

 -  FOR THE MAIN TRIAL, NN5401-3594:

 -  Treatment with other insulin regimens than insulin in a basal bolus regimen/premix
 insulin regimen/self mix regimen within 3 months

 -  Cardiovascular disease within the last 6 months

 -  Uncontrolled treated/untreated severe hypertension

 -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
 contraceptive measures according to local requirements

 -  Cancer and medical history of cancer

 -  FOR THE EXTENSION TRIAL, NN5401-3645:

 -  Anticipated significant lifestyle changes during the trial

 -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
 contraceptive measures