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NCT00097071 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
299
Enrollment target

NCT00097071: Completed Phase 3 study, sponsored by Novo Nordisk A/S.

NCT00097071 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 299 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00097071, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
299 participants
Enrollment target

Study 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

  • DRUG insulin aspart
  • DRUG insulin lispro

Trial Details

FieldValue
Enrollment Target 299 participants
Start Date 2004-10
Est. Completion 2006-05
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the finished NCT00097071 record still lists

NCT00097071 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).

The record links to 0 conditions, and to 2 interventions - of which insulin aspart is the first listed.

NCT00097071 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00097071 about?

NCT00097071 is a clinical study titled "Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents". 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 i...

What is the current status of trial NCT00097071?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 299 participants. The study started on 2004-10. Estimated completion is 2006-05.

What interventions are being tested in trial NCT00097071?

The interventions under investigation include: insulin aspart (DRUG), insulin lispro (DRUG).

Who is sponsoring clinical trial NCT00097071?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00097071's enrollment target sits among peer trials

299 1161st of 2000 higher than 839 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00097071, the US trial registry maintained by the National Library of Medicine. NCT00097071 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.