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

Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00097071

Enrollment

299

Registered

2004-11-18

Start date

2004-10-31

Completion date

2006-05-31

Last updated

2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

Keywords

Diabetes, Type 1

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.

Interventions

DRUGinsulin lispro

DRUGinsulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Type 1 Diabetes

Design outcomes

Primary

Measure	Time frame
HbA1c	After 16 weeks treatment

Secondary

Measure	Time frame
Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026