Clinical Trial Details
| Trial ID: | L4367 |
| Source ID: | NCT01467141 |
| Associated Drug: | Insulin Aspart |
| Title: | Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes|Diabetes Mellitus, Type 1 |
| Interventions: | DRUG: insulin aspart|DRUG: human insulin|DRUG: isophane human insulin |
| Outcome Measures: | Primary: Incidence of hypoglycaemic episodes during the treatment, Week 0; week 24|Change in HbA1c (glycosylated haemoglobin A1c), Week 0; week 24 | Secondary: Incidence of Adverse Events (AEs), Week 0; week 24 |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | CHILD |
| Phases: | PHASE4 |
| Enrollment: | 26 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2002-06-19 |
| Completion Date: | 2003-10-15 |
| Results First Posted: | |
| Last Update Posted: | 2017-02-23 |
| Locations: | Novo Nordisk Investigational Site, Berlin, 13353, Germany|Novo Nordisk Investigational Site, Dresden, 01307, Germany|Novo Nordisk Investigational Site, Hagen, 58095, Germany|Novo Nordisk Investigational Site, Hamburg, 22149, Germany|Novo Nordisk Investigational Site, Hannover, 30173, Germany|Novo Nordisk Investigational Site, Osnabrück, 49082, Germany |
| URL: | https://clinicaltrials.gov/show/NCT01467141 |

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