Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes
Phase 4
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT01467141
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- Type 1 diabetes
- Treatment with insulin for at least 6 months prior to inclusion
- HbA1c below or equal to 11.0 %
- Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion
Exclusion Criteria
- The receipt of any investigational drug within one month prior to this trial
- Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
- Total daily insulin doses at least 1.80 IU/kg
- Treatment with oral hypoglycaemic agents
- Known or suspected allergy to trial product or related products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IAsp isophane human insulin - HI isophane human insulin - IAsp insulin aspart - HI human insulin -
- Primary Outcome Measures
Name Time Method Incidence of hypoglycaemic episodes during the treatment Week 0; week 24 Change in HbA1c (glycosylated haemoglobin A1c) Week 0; week 24
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Week 0; week 24
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Osnabrück, Germany
Novo Nordisk Investigational Site🇩🇪Osnabrück, Germany