Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population

Basal/Bolus Therapy With Insulin Aspart (NovoLog®) Versus Regular Human Insulin (Novolin® R) or Insulin Lispro (Humalog®) in Combination With NPH: An Open-Label, Randomized, Parallel Group, Multicenter Study in Children and Adolescents With Type 1 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00071448

Enrollment

378

Registered

2003-10-24

Start date

2002-06-30

Completion date

2004-06-30

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

Brief summary

This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.

Interventions

DRUGinsulin human

DRUGinsulin lispro

DRUGinsulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

Yes

Inclusion criteria

* Pediatric patients with Type 1 diabetes for at least one year * HbA1c less than 12% * Willing to administer at least 3 injections per day * Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary

Design outcomes

Primary

Measure	Time frame
HbA1c (glycosylated haemoglobin A1c)	—

Secondary

Measure	Time frame
FPG (fasting plasma glucose)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026