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Completed

NCT Number: 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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

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

insulin aspart

Drug

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

Primary outcomes

  1. Glycosylated Haemoglobin A1c (HbA1c)

    Time frame: Week 0 and Week 8

    Measured for the Per Protocol (PP) set

  2. Glycosylated Haemoglobin A1c (HbA1c)

    Time frame: Week 0 and Week 8

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

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

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2 hours (hrs), T2.5hrs, T3hrs, T3.5hrs, T4hrs

  7. Pharmacokinetics: Tmax of Free Insulin

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

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

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  9. Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  10. Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  11. Pharmacokinetics: Cmax of Insulin Detemir

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  12. Pharmacokinetics: Tmax of Insulin Detemir

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

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

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  14. Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  15. Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  16. Pharmacokinetics: Cmax of Insulin Aspart

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  17. Pharmacokinetics: Tmax of Insulin Aspart

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

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

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  19. Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  20. Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart

    Time frame: Week 0 and Week 8

    The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs

  21. Weight Z Score

    Time frame: Week 0 and Week 8

    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

  22. Body Mass Index (BMI) Z Score

    Time frame: Week 0 and Week 8

    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

  23. Incidence of Hypoglycaemic Episodes - All Episodes

    Time frame: Weeks 0-8

    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.

  24. Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L

    Time frame: Weeks 0-8

    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.

  25. Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L

    Time frame: Weeks 0-8

    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.

  26. Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"

    Time frame: Week 0 and Week 8

    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.

  27. Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"

    Time frame: Week 0 and week 8

    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.

  28. Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"

    Time frame: Week 0 and Week 8

    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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: MIXING

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 11, 2007
Registry last updated
Nov 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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