Safety of Insulin Detemir in Children With Type 1 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT00605137
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of hypoglycaemic episodes during treatment
- Secondary Outcome Measures
Name Time Method Laboratory assessments and other safety endpoints HbA1C, self monitored blood glucose and within-subject variability of glucose Height Insulin doses Adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan