Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT00097071
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 299
Inclusion Criteria
- Type 1 Diabetes
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1c After 16 weeks treatment
- Secondary Outcome Measures
Name Time Method Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸Milwaukee, Wisconsin, United States