DiabetesPhase 4MIXINGNCT00542620

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 study testing insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 1
What is being tested?: insulin detemir and insulin aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteFrance
Study dates: Sep 2007to Mar 2009
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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%

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

Study site
Paris

Other trials in France

About this study

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

Conditions: Diabetes, Diabetes Mellitus, Type 1
Being tested: insulin detemir, insulin aspart
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00542620
Study group	Role	What they receive
Mixed injection	Experimental	Not described Receives: Drug: insulin detemir; Drug: insulin aspart
Separate injection	Active comparator	Not described Receives: Drug: insulin detemir; Drug: insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

Glycosylated Haemoglobin A1c (HbA1c)
Measured for the Per Protocol (PP) set
Measured: Week 0 and Week 8
Glycosylated Haemoglobin A1c (HbA1c)
Measured for the ITT (Intention-to-Treat) set
Measured: Week 0 and Week 8

Secondary outcomes (28)

Fructosamine
Measured: Week 0 and Week 8
Self-measured Plasma Glucose Profile (Before Breakfast)
Measured: Week 0 and Week 8
Self-measured Plasma Glucose Profile (After Breakfast)
Measured: Week 0 and Week 8
Self-measured Plasma Glucose Profile (Before Dinner)
Measured: Week 0 and Week 8
Self-measured Plasma Glucose Profile (After Dinner)
Measured: 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
Measured: 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
Measured: 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
The observed peak drug concentration at time (T): T0, T0.5hour (hr), T1hr, T1.5hr, T2hrs, T2.5hrs, T3hrs, T3.5hrs, T4hrs
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0 and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Mar 2009

First posted11 Oct 2007 (estimated)
Study startSep 2007
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00542620
Sponsor's protocol ID: NN304-1813
Other IDs: 2006-006715-77
Acronym: MIXING
Status last verified: Oct 2014
First submitted: 10 Oct 2007
Last updated: 3 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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