drugset / Trial / NCT00097071

Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents

NCT00097071 ↗

Phase 3 Completed 299 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2004-10
Primary completion
2006-05
Completion
2006-05

Outcome

Met primary endpoint

paper insulin aspart CSII was noninferior to insulin lispro CSII as measured by change in A1C from baseline PMID 17989308 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Lispro Protein / enzyme biologic — Subcutaneous
Subject insulin aspart Protein / enzyme biologic — Subcutaneous