NCT00410033 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Holmberg H, Mersebach H, Hanzel KK, Ludvigsson J
Antibody response to insulin in children and adolescents with newly diagnosed type 1 diabetes. ADA 2007; 56 (Suppl. 1): A476 (1885-P
Ludvigsson J, Mersebach H, Kanc Hanzel K, Holmberg H
Treatment with insulin aspart versus human insulin in children and adolescents with newly diagnosed type 1 diabetes. EASD 2007; 50(Suppl 1): S380

Safety/Efficacy Trial Using Stored Serum Samples to Investigate the Immunogenicity of Insulin Aspart and Soluble Human Insulin in Children and Adolescents From Onset of Type 1 Diabetes

Details for clinical trial NCT00410033

Clinical trial NCT00410033 - References