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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542620

2006-006715-77 (EudraCT Number)

NN304-1813

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Mixed injection

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin detemir

Drug: insulin aspart

Drug: insulin detemir

Separate injection

Active Comparator group

Treatment:

Drug: insulin aspart

Drug: insulin detemir

Drug: insulin aspart

Drug: insulin detemir