Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

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