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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Detemir; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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)