Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes

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

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.

Inclusion Criteria:

• Type 1 diabetes for at least 12 months
• Basal-bolus treatment for at least 3 months
• Body Mass Index (BMI) less than or equal to 35.0 kg/m^2
• HbA1c (glycosylated haemoglobin) less than or equal to 12.0%

Exclusion Criteria:

• Known or suspected allergy to trial products or related products
• Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
• Receipt of any trial drug within 1 month prior to this trial
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
• Conditions that may interfere with trial participation as judged by Investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)