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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00542620
First received: October 10, 2007
Last updated: December 11, 2012
Last verified: December 2012
Results First Received: December 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 1
Interventions: Drug: insulin detemir
Drug: insulin aspart

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Four centres in France

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Children with type 1 diabetes currently treated with insulin detemir and insulin aspart and with a good glycaemic control. At trial entry, subjects must be 6-18 years old with a HbA1c (glycosylated haemoglobin) below or equal to 8.6%

Reporting Groups
  Description
Mixed Injection Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Separate Injection Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed

Participant Flow:   Overall Study
    Mixed Injection     Separate Injection  
STARTED     13     12  
Exposed to Drug     12 [1]   13 [1]
COMPLETED     13     12  
NOT COMPLETED     0     0  
[1] One subject randomly assigned to receive mixed injections, but received a separate injection mode



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mixed Injection Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Separate Injection Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
Total Total of all reporting groups

Baseline Measures
    Mixed Injection     Separate Injection     Total  
Number of Participants  
[units: participants]
  13     12     25  
Age  
[units: years]
Mean ± Standard Deviation
  11.6  ± 2.6     10.9  ± 2.5     11.3  ± 2.5  
Gender  
[units: participants]
     
Female     5     7     12  
Male     8     5     13  
Region of Enrollment  
[units: participants]
     
France     13     12     25  
Diabetes history [1]
[units: years]
Mean ± Standard Deviation
  6.68  ± 3.51     6.13  ± 2.38     6.42  ± 2.97  
[1] Number of years since diagnosis



  Outcome Measures
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1.  Primary:   Glycosylated Haemoglobin A1c (HbA1c)   [ Time Frame: Week 0 and Week 8 ]

2.  Primary:   Glycosylated Haemoglobin A1c (HbA1c)   [ Time Frame: Week 0 and Week 8 ]

3.  Secondary:   Fructosamine   [ Time Frame: Week 0 and Week 8 ]

4.  Secondary:   Self-measured Plasma Glucose Profile (Before Breakfast)   [ Time Frame: Week 0 and Week 8 ]

5.  Secondary:   Self-measured Plasma Glucose Profile (After Breakfast)   [ Time Frame: Week 0 and Week 8 ]

6.  Secondary:   Self-measured Plasma Glucose Profile (Before Dinner)   [ Time Frame: Week 0 and Week 8 ]

7.  Secondary:   Self-measured Plasma Glucose Profile (After Dinner)   [ Time Frame: Week 0 and Week 8 ]

8.  Secondary:   Pharmacokinetics: Cmax of Free Insulin   [ Time Frame: Week 0 and Week 8 ]

9.  Secondary:   Pharmacokinetics: Tmax of Free Insulin   [ Time Frame: Week 0 and Week 8 ]

10.  Secondary:   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 ]

11.  Secondary:   Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin   [ Time Frame: Week 0 and Week 8 ]

12.  Secondary:   Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin   [ Time Frame: Week 0 and Week 8 ]

13.  Secondary:   Pharmacokinetics: Cmax of Insulin Detemir   [ Time Frame: Week 0 and Week 8 ]

14.  Secondary:   Pharmacokinetics: Tmax of Insulin Detemir   [ Time Frame: Week 0 and Week 8 ]

15.  Secondary:   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 ]

16.  Secondary:   Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir   [ Time Frame: Week 0 and Week 8 ]

17.  Secondary:   Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir   [ Time Frame: Week 0 and Week 8 ]

18.  Secondary:   Pharmacokinetics: Cmax of Insulin Aspart   [ Time Frame: Week 0 and Week 8 ]

19.  Secondary:   Pharmacokinetics: Tmax of Insulin Aspart   [ Time Frame: Week 0 and Week 8 ]

20.  Secondary:   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 ]

21.  Secondary:   Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart   [ Time Frame: Week 0 and Week 8 ]

22.  Secondary:   Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart   [ Time Frame: Week 0 and Week 8 ]

23.  Secondary:   Weight Z Score   [ Time Frame: Week 0 and Week 8 ]

24.  Secondary:   Body Mass Index (BMI) Z Score   [ Time Frame: Week 0 and Week 8 ]

25.  Secondary:   Incidence of Hypoglycaemic Episodes - All Episodes   [ Time Frame: Weeks 0-8 ]

26.  Secondary:   Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L   [ Time Frame: Weeks 0-8 ]

27.  Secondary:   Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L   [ Time Frame: Weeks 0-8 ]

28.  Secondary:   Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face"   [ Time Frame: Week 0 and Week 8 ]

29.  Secondary:   Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face"   [ Time Frame: Week 0 and week 8 ]

30.  Secondary:   Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face"   [ Time Frame: Week 0 and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


No publications provided


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00542620     History of Changes
Other Study ID Numbers: NN304-1813, 2006-006715-77
Study First Received: October 10, 2007
Results First Received: December 5, 2011
Last Updated: December 11, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)