Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact in choosing one regimen over another.

• Phase: Phase 4
• 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:

• Parents' Informed Consent (IC) obtained before any trial-related activities

• Obtained child's assent (when possible)

• Type 1 diabetes

• Treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections

• HbA1c (glycosylated haemoglobin A1c) lesser than or equal to 8.6%

Exclusion Criteria:

• History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol

• Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation

• Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)

• Any other condition that the Investigator (trial physician) feels would interfere with trial participation or evaluation of results