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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00542620
First Posted: October 11, 2007
Last Update Posted: November 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin aspart Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: Week 0 and Week 8 ]
    Measured for the Per Protocol (PP) set

  • Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: Week 0 and Week 8 ]
    Measured for the ITT (Intention-to-Treat) set


Secondary Outcome Measures:
  • 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 [ 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 25
Study Start Date: September 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mixed injection Drug: insulin detemir
Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin aspart
Drug: insulin aspart
Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, mixed with insulin detemir
Active Comparator: Separate injection Drug: insulin detemir
Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin aspart
Drug: insulin aspart
Treat-to-target (individually adjusted) dose titration, s.c. (under the skin) injection, twice a day, injected separately with insulin detemir

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542620


Locations
France
Paris, France
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00542620     History of Changes
Other Study ID Numbers: NN304-1813
2006-006715-77 ( EudraCT Number )
First Submitted: October 10, 2007
First Posted: October 11, 2007
Results First Submitted: December 5, 2011
Results First Posted: January 18, 2013
Last Update Posted: November 3, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs