Clinical trial NCT00542620: Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
Official title: A Randomised, Multicentric, Open Labelled, Parallel Group Trial With Insulin Aspart and Insulin Detemir, Investigating the Glycaemic Effect and Profile in Children With Type 1 Diabetes, of Two Separate Levemir® + NovoRapid® Injections and Extemporaneous Mixing - The Paediatric MIXING Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: Week 0 and Week 8
measure: Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: Week 0 and Week 8
Secondary outcomes:
measure: Fructosamine
timeFrame: Week 0 and Week 8
measure: Self-measured Plasma Glucose Profile (Before Breakfast)
timeFrame: Week 0 and Week 8
measure: Self-measured Plasma Glucose Profile (After Breakfast)
timeFrame: Week 0 and Week 8
measure: Self-measured Plasma Glucose Profile (Before Dinner)
timeFrame: Week 0 and Week 8
measure: Self-measured Plasma Glucose Profile (After Dinner)
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Cmax of Free Insulin
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Tmax of Free Insulin
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Cmax of Insulin Detemir
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Tmax of Insulin Detemir
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Cmax of Insulin Aspart
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Tmax of Insulin Aspart
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart
timeFrame: Week 0 and Week 8
measure: Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart
timeFrame: Week 0 and Week 8
measure: Weight Z Score
timeFrame: Week 0 and Week 8
measure: Body Mass Index (BMI) Z Score
timeFrame: Week 0 and Week 8
measure: Incidence of Hypoglycaemic Episodes - All Episodes
timeFrame: Weeks 0-8
measure: Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L
timeFrame: Weeks 0-8
measure: Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L
timeFrame: Weeks 0-8
measure: Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"
timeFrame: Week 0 and Week 8
measure: Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"
timeFrame: Week 0 and week 8
measure: Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"
timeFrame: Week 0 and Week 8
Other outcomes:
Locations:
city: Paris
country: France
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: