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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart
Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir
Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin aspart
Unnamed facility
Paris, France
Glycosylated Haemoglobin A1c (HbA1c)
Measured for the Per Protocol (PP) set
Time frame: Week 0 and Week 8
Glycosylated Haemoglobin A1c (HbA1c)
Measured for the ITT (Intention-to-Treat) set
Time frame: Week 0 and Week 8
Fructosamine
Time frame: Week 0 and Week 8
Self-measured Plasma Glucose Profile (Before Breakfast)
Time frame: Week 0 and Week 8
Self-measured Plasma Glucose Profile (After Breakfast)
Time frame: Week 0 and Week 8
Self-measured Plasma Glucose Profile (Before Dinner)
Time frame: Week 0 and Week 8
Self-measured Plasma Glucose Profile (After Dinner)
Time frame: Week 0 and Week 8
Pharmacokinetics: Cmax of Free Insulin
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Tmax of Free Insulin
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin detemir
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Cmax of Insulin Detemir
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Tmax of Insulin Detemir
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Cmax of Insulin Aspart
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Tmax of Insulin Aspart
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Time frame: Week 0 and Week 8
Weight Z Score
Z score of weight. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex
Time frame: Week 0 and Week 8
Body Mass Index (BMI) Z Score
Z score of BMI index. To estimate the growth of children, standardised mean BMI values were calculated for each month of age and for each sex
Time frame: Week 0 and Week 8
Incidence of Hypoglycaemic Episodes - All Episodes
Number of hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose less than 56 mg/dL (3.1 mmol/L). Classified as major, minor or symptoms only. Major if unable to treat her/himself (given the age of the study population, the definition of major hypoglycemia was to be adapted through the investigator's judgment). Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-8
Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L
Number of minor hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose below 3.1 mmol/L (56 mg/dL) and the child is able to treat her/himself.
Time frame: Weeks 0-8
Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L
Number of "symptoms only" hypoglycaemic episodes from Week 0 to Week 8, defined as self-measurement plasma glucose higher than or equal to 3.1 mmol/L (56 mg/dL) or no plasma glucose measurement and the child is able to treat her/himself.
Time frame: Weeks 0-8
Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"
Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.
Time frame: Week 0 and Week 8
Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"
Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.
Time frame: Week 0 and week 8
Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"
Via a paper diary, the children perceived insulin therapy injection pain by using a four-grade facial visual analogue scale (VAS): very sad face, sad face, happy face or very happy face.
Time frame: Week 0 and Week 8