Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Japan. The aim of trial is to investigate the safety of insulin detemir and insulin NPH in children with type 1 diabetes.
Interventions
DRUGinsulin detemir
DRUGinsulin NPH
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes for at least one year * Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin * HbA1C below 11.0% * Willing to comply with Investigator's instructions * Able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia
Exclusion criteria
* Impaired renal function * Impaired hepatic function * Known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the Investigator or Sub-Investigator) * Proliferative retinopathy or maculopathy requiring acute treatment * Uncontrolled treated/untreated hypertension * Current treatment with total daily insulin dose of more than 2.00 IU/kg * Current treatment or expected at the screening to start treatment with systemic corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hypoglycaemic episodes | during treatment |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
| Laboratory assessments and other safety endpoints | — |
| HbA1C, self monitored blood glucose and within-subject variability of glucose | — |
| Height | — |
| Insulin doses | — |
Countries
Japan
Outcome results
None listed