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CompletedNCT00542620MIXINGUpdated Nov 2, 2014Results posted

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

A Phase 4 interventional study of insulin detemir and insulin aspart in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in France. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2014-11-02.

Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 25 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Mixed injection

    Drug: insulin detemir · Drug: insulin aspart

  • Active comparator
    Separate injection

    Drug: insulin detemir · Drug: insulin aspart

Interventions

  • Druginsulin detemir

    Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart

  • Druginsulin aspart

    Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir

  • Druginsulin detemir

    Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin aspart

  • Druginsulin aspart

    Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin detemir

06

What researchers measure

Primary outcomes

  1. Glycosylated Haemoglobin A1c (HbA1c)

    Measured for the Per Protocol (PP) set

    Time frame: Week 0 and Week 8

  2. Glycosylated Haemoglobin A1c (HbA1c)

    Measured for the ITT (Intention-to-Treat) set

    Time frame: Week 0 and Week 8

Secondary outcomes

  1. Fructosamine

    Time frame: Week 0 and Week 8

  2. Self-measured Plasma Glucose Profile (Before Breakfast)

    Time frame: Week 0 and Week 8

  3. Self-measured Plasma Glucose Profile (After Breakfast)

    Time frame: Week 0 and Week 8

  4. Self-measured Plasma Glucose Profile (Before Dinner)

    Time frame: Week 0 and Week 8

  5. Self-measured Plasma Glucose Profile (After Dinner)

    Time frame: Week 0 and Week 8

  6. 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

  7. 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

  8. Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

07

Results

Posted Jan 18, 2013

Participant flow

Four centres in France

Participant flow — Overall Study
MilestoneMixed InjectionSeparate Injection
Started1312
Exposed to drug1213
Completed1312
Not completed00

Outcome measures

PrimaryGlycosylated Haemoglobin A1c (HbA1c)

Measured for the Per Protocol (PP) set

Time frame:
Week 0 and Week 8
Reported as:
Mean · percentage of total haemoglobin
Glycosylated Haemoglobin A1c (HbA1c)
percentage of total haemoglobinMixed InjectionSeparate Injection
Week 08.00 ± 0.547.77 ± 0.55
Week 87.63 ± 0.558.15 ± 0.57
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.001 (If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated) · Median difference (final values): -0.691 · 95% CI -1.049 to -0.334Baseline HbA1c as covariate
PrimaryGlycosylated Haemoglobin A1c (HbA1c)

Measured for the ITT (Intention-to-Treat) set

Time frame:
Week 0 and Week 8
Reported as:
Mean · percentage of total haemoglobin
Glycosylated Haemoglobin A1c (HbA1c)
percentage of total haemoglobinMixed InjectionSeparate Injection
Week 07.93 ± 0.577.77 ± 0.55
Week 87.65 ± 0.538.15 ± 0.57
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.003 (If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated.) · Mean difference (final values): -0.594 · 95% CI -0.970 to -0.219Baseline HbA1c as covariate.
SecondaryFructosamine
Time frame:
Week 0 and Week 8
Reported as:
Mean · mmol/L
Fructosamine
mmol/LMixed InjectionSeparate Injection
Week 0, n=13, 12334.8 ± 35.9319.8 ± 22.6
Week 8, n=12, 12316.4 ± 30.1334.8 ± 41.9
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.573 · Mean difference (final values): -8.35 · 95% CI -38.77 to 22.08With adjustment on baseline fructosamine and the change in insulin administration mode
SecondarySelf-measured Plasma Glucose Profile (Before Breakfast)
Time frame:
Week 0 and Week 8
Reported as:
Mean · mg/dL
Self-measured Plasma Glucose Profile (Before Breakfast)
mg/dLMixed InjectionSeparate Injection
Week 0190.31 ± 56.80165.39 ± 70.28
Week 8162.96 ± 57.46204.75 ± 59.25
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.063With adjustment on baseline value
SecondarySelf-measured Plasma Glucose Profile (After Breakfast)
Time frame:
Week 0 and Week 8
Reported as:
Mean · mg/dL
Self-measured Plasma Glucose Profile (After Breakfast)
mg/dLMixed InjectionSeparate Injection
Week 0, n=5, 6123.00 ± 61.9164.89 ± 73.33
Week 8, n=4, 7208.08 ± 48.19167.98 ± 70.64
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.389With adjustment on baseline value
SecondarySelf-measured Plasma Glucose Profile (Before Dinner)
Time frame:
Week 0 and Week 8
Reported as:
Mean · mg/dL
Self-measured Plasma Glucose Profile (Before Dinner)
mg/dLMixed InjectionSeparate Injection
Week 0199.14 ± 42.05201.44 ± 57.50
Week 8185.23 ± 66.30181.03 ± 68.41
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.856With adjustment on baseline value
SecondarySelf-measured Plasma Glucose Profile (After Dinner)
Time frame:
Week 0 and Week 8
Reported as:
Mean · mg/dL
Self-measured Plasma Glucose Profile (After Dinner)
mg/dLMixed InjectionSeparate Injection
Week 0, n=8, 5175.38 ± 58.47201.80 ± 59.12
Week 8, n=7, 6198.00 ± 53.85187.67 ± 85.63
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.917With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · pmol/L
Pharmacokinetics: Cmax of Free Insulin
pmol/LMixed InjectionSeparate Injection
Week 0216 ± 542.4167 ± 130.4
Week 8274 ± 109.2186 ± 105.5
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.209With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · hours
Pharmacokinetics: Tmax of Free Insulin
hoursMixed InjectionSeparate Injection
Week 02.5 ± 0.743.0 ± 0.98
Week 82.5 ± 0.81.8 ± 0.72
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.220With adjustment on baseline value
SecondaryPharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level 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
Reported as:
Median · pmol.h/L
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin
pmol.h/LMixed InjectionSeparate Injection
Week 0638.4 ± 1022.95398.9 ± 395.19
Week 8819.6 ± 310.41466.2 ± 266.93
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.234With adjustment for baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · pmol.h/L
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin
pmol.h/LMixed InjectionSeparate Injection
Week 0, n=8, 91441.3 ± 7516.22752.1 ± 4128.04
Week 8, n=11, 111981.1 ± 1442.49672.8 ± 7156.05
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.534With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · hours
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin
hoursMixed InjectionSeparate Injection
Week 0, n=8, 93.6 ± 17.842.3 ± 10.93
Week 8, n=11, 112.9 ± 3.342.0 ± 11.62
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.722With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · pmol/L
Pharmacokinetics: Cmax of Insulin Detemir
pmol/LMixed InjectionSeparate Injection
Week 010700 ± 25149.910500 ± 6840.2
Week 812000 ± 23807.212600 ± 8426.6
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.727With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · hours
Pharmacokinetics: Tmax of Insulin Detemir
hoursMixed InjectionSeparate Injection
Week 03.5 ± 0.933.5 ± 0.48
Week 83.5 ± 0.383.3 ± 0.78
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.411With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · pmol.h/L
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir
pmol.h/LMixed InjectionSeparate Injection
Week 036591.2 ± 70709.534653.4 ± 21243.3
Week 836055.0 ± 73609.639757.0 ± 23076.5
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.471With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · pmol.h/L
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir
pmol.h/LMixed InjectionSeparate Injection
Week 0, n=4, 3230728.2 ± 304790.6268509.6 ± 116350.34
Week 8, n=3, 6123555.7 ± 141207.72362313.5 ± 4287360.41
SecondaryPharmacokinetics: 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
Reported as:
Median · hours
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir
hoursMixed InjectionSeparate Injection
Week 0, n=4, 316.2 ± 4.128.2 ± 6.53
Week 8, n=3, 65.6 ± 4.220.8 ± 249.57
SecondaryPharmacokinetics: 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
Reported as:
Median · pmol/L
Pharmacokinetics: Cmax of Insulin Aspart
pmol/LMixed InjectionSeparate Injection
Week 0557 ± 2784.2762 ± 378.3
Week 8662 ± 576.3601 ± 355.3
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.127With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · hours
Pharmacokinetics: Tmax of Insulin Aspart
hoursMixed InjectionSeparate Injection
Week 02 ± 0.992 ± 0.97
Week 82 ± 0.531.5 ± 0.51
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.1With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · pmol.h/L
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart
pmol.h/LMixed InjectionSeparate Injection
Week 01546.3 ± 3163.271510.9 ± 963.37
Week 82102.4 ± 1378.731540 ± 894.4
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.166With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · pmol.h/L
Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart
pmol.h/LMixed InjectionSeparate Injection
Week 0, n=10, 113008.1 ± 7689.043006.3 ± 4458.12
Week 8, n=13, 125674.3 ± 10668.83019.9 ± 1013.19
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.023With adjustment on baseline value
SecondaryPharmacokinetics: 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
Reported as:
Median · hours
Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart
hoursMixed InjectionSeparate Injection
Week 0, n=10, 112.2 ± 6.752 ± 3.09
Week 8, n=13, 123.5 ± 41.881.7 ± 1.62
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.439With adjustment on baseline value
SecondaryWeight 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
Reported as:
Mean · Z-score
Weight Z Score
Z-scoreMixed InjectionSeparate Injection
Week 0, n=13, 12-0.42 ± 0.710.19 ± 0.69
Week 8, n=11, 12-0.29 ± 0.650.26 ± 0.67
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.202With adjustment on baseline value
SecondaryBody 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
Reported as:
Mean · Z-score
Body Mass Index (BMI) Z Score
Z-scoreMixed InjectionSeparate Injection
Week 0, n=13, 12-0.32 ± 0.630.04 ± 0.86
Week 8, n=11, 12-0.07 ± 0.520.26 ± 0.73
Statistical analysis
  • Mixed Injection vs Separate Injection · ANCOVA · p = 0.665With adjustment on baseline value
SecondaryIncidence 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
Reported as:
Number · episodes
Incidence of Hypoglycaemic Episodes - All Episodes
episodesMixed InjectionSeparate Injection
Incidence of Hypoglycaemic Episodes - All Episodes351293
SecondaryIncidence 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
Reported as:
Number · episodes
Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L
episodesMixed InjectionSeparate Injection
With symptoms68159
Without (w/o) symptoms7548
W/o info on presence of symptoms236
SecondaryIncidence 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
Reported as:
Number · episodes
Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L
episodesMixed InjectionSeparate Injection
With symptoms4946
Without (w/o) symptoms13133
W/o information on presence of symptoms51
SecondaryPercentage 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
Reported as:
Number · percentage of subjects
Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"
percentage of subjectsMixed InjectionSeparate Injection
Week 04533
Week 8023
SecondaryPercentage 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
Reported as:
Number · percentage of subjects
Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"
percentage of subjectsMixed InjectionSeparate Injection
Week 02750
Week 88169
SecondaryPercentage 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
Reported as:
Number · percentage of subjects
Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"
percentage of subjectsMixed InjectionSeparate Injection
Week 027.316.7
Week 818.27.7

Adverse events

Collected over Adverse events are collected during treatment period (8 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mixed Injection—0/12 (0%)5/12 (41.7%)
Separate Injection—0/13 (0%)9/13 (69.2%)
Most frequent other events
Showing 10 of 16
Most frequent other events
EventMixed InjectionSeparate Injection
Abdominal painGastrointestinal disorders0/123/13
RhinitisInfections and infestations1/122/13
GastroenteritisInfections and infestations1/121/13
BronchitisInfections and infestations1/120/13
Viral infectionInfections and infestations1/120/13
Tooth extractionSurgical and medical procedures1/120/13
Conjunctivitis allergicEye disorders1/120/13
EczemaSkin and subcutaneous tissue disorders1/120/13
EnterobiasisInfections and infestations0/121/13
NasopharyngitisInfections and infestations0/121/13

Baseline characteristics

Age, Continuous
Age, Continuous(years)Mixed InjectionSeparate InjectionTotal
Mean11.6 ± 2.610.9 ± 2.511.3 ± 2.5
Sex: Female, Male
Sex: Female, Male(Participants)Mixed InjectionSeparate InjectionTotal
Female5712
Male8513
Region of Enrollment
Region of Enrollment(participants)Mixed InjectionSeparate InjectionTotal
France131225
Diabetes history
Diabetes history(years)Mixed InjectionSeparate InjectionTotal
Mean6.68 ± 3.516.13 ± 2.386.42 ± 2.97
08

Study locations

1 site
  • Paris, France
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00542620
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 11, 2007
Start date
Sep 2007
Primary completion
Mar 2009
Completion
Mar 2009
Results posted
Jan 18, 2013
Last update
Nov 2, 2014

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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