Phase 4
Completed N=25
Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00542620 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Glycosylated Haemoglobin A1c (HbA1c) — 8.00; 7.77; 7.63; 8.15 percentage of total haemoglobin — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Haemoglobin A1c (HbA1c) |
7.93; 7.77; 7.65; 8.15 | 0.003 sig |
| PRIMARY Glycosylated Haemoglobin A1c (HbA1c) |
7.93; 7.77; 7.65; 8.15 | 0.003 sig |
| SECONDARY Fructosamine |
334.8; 319.8; 316.4; 334.8 | 0.573 |
| SECONDARY Self-measured Plasma Glucose Profile (Before Breakfast) |
190.31; 165.39; 162.96; 204.75 | 0.063 |
| SECONDARY Self-measured Plasma Glucose Profile (After Breakfast) |
123.00; 164.89; 208.08; 167.98 | 0.389 |
| SECONDARY Self-measured Plasma Glucose Profile (Before Dinner) |
199.14; 201.44; 185.23; 181.03 | 0.856 |
| SECONDARY Self-measured Plasma Glucose Profile (After Dinner) |
175.38; 201.80; 198.00; 187.67 | 0.917 |
| SECONDARY Pharmacokinetics: Cmax of Free Insulin |
216; 167; 274; 186 | 0.209 |
| SECONDARY Pharmacokinetics: Tmax of Free Insulin |
2.5; 3.0; 2.5; 1.8 | 0.220 |
| SECONDARY Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Free Insulin |
638.4; 398.9; 819.6; 466.2 | 0.234 |
| SECONDARY Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Free Insulin |
1441.3; 752.1; 1981.1; 672.8 | 0.534 |
| SECONDARY Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Free Insulin |
3.6; 2.3; 2.9; 2.0 | 0.722 |
| SECONDARY Pharmacokinetics: Cmax of Insulin Detemir |
10700; 10500; 12000; 12600 | 0.727 |
| SECONDARY Pharmacokinetics: Tmax of Insulin Detemir |
3.5; 3.5; 3.5; 3.3 | 0.411 |
| SECONDARY Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Detemir |
36591.2; 34653.4; 36055.0; 39757.0 | 0.471 |
| SECONDARY Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Detemir |
230728.2; 68509.6; 123555.7; 362313.5 | — |
| SECONDARY Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Detemir |
16.2; 8.2; 5.6; 20.8 | — |
| SECONDARY Pharmacokinetics: Cmax of Insulin Aspart |
557; 762; 662; 601 | 0.127 |
| SECONDARY Pharmacokinetics: Tmax of Insulin Aspart |
2; 2; 2; 1.5 | 0.1 |
| SECONDARY Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to the Time of the Last Measured Level of Insulin Aspart |
1546.3; 1510.9; 2102.4; 1540 | 0.166 |
| SECONDARY Pharmacokinetics: Area Under the Concentration vs. Time Curve From Time Zero to Infinity of Insulin Aspart |
3008.1; 3006.3; 5674.3; 3019.9 | 0.023 sig |
| SECONDARY Pharmacokinetics: Terminal Phase Elimination Half-life (T½) - Parameter of Insulin Aspart |
2.2; 2; 3.5; 1.7 | 0.439 |
| SECONDARY Weight Z Score |
-0.42; 0.19; -0.29; 0.26 | 0.202 |
| SECONDARY Body Mass Index (BMI) Z Score |
-0.32; 0.04; -0.07; 0.26 | 0.665 |
| SECONDARY Incidence of Hypoglycaemic Episodes - All Episodes |
351; 293 | — |
| SECONDARY Incidence of Hypoglycaemic Episodes - Glycaemia Below 0.56 g/L |
68; 159; 75; 48; 23; 6 | — |
| SECONDARY Incidence of Hypoglycaemic Episodes - Glycaemia Above or Equal to 0.56 g/L |
49; 46; 131; 33; 5; 1 | — |
| SECONDARY Percentage of Children Assessing Insulin Therapy Injection Pain as "Sad Face" |
45; 33; 0; 23 | — |
| SECONDARY Percentage of Children Assessing Insulin Therapy Injection Pain as "Happy Face" |
27; 50; 81; 69 | — |
| SECONDARY Percentage of Children Assessing Insulin Therapy Injection Pain as "Very Happy Face" |
27.3; 16.7; 18.2; 7.7 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00542620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.