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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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:

• 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