Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes

• Status: Completed
• Trial end date: 2004-01-29
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.

• 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, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Subjects with type 1 diabetes

• Duration of diabetes for at least 12 months

• Treatment with insulin aspart for at least 3 months before trial start

• Body Mass Index (BMI) below 35.0 kg/m2

• HbA1c below 12.0%

Exclusion Criteria:

• Total insulin dosage more than 1.4 IU/kg/day

• Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)

• Known hypoglycaemia unawareness as judged by the investigator

• Known hypersensitivity or allergy