FindTrial
Sign In

Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes

Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes Mellitus

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00571935
Enrollment
61
Registered
2007-12-12
Start date
2003-08-31
Completion date
2004-10-31
Last updated
2016-12-21

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 Europe. The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.

Interventions

DRUGinsulin aspart
DRUGsoluble human insulin

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
No

Inclusion criteria

* Type 1 diabetes for at least 1 year * HbA1c below 12.0% * Treatment with regular human insulin and insulin NPH for at least 1 month * Receive more than 2 injections daily

Exclusion criteria

* Receipt of investigational product within 6 months prior to trial participation * Known or suspected allergy to investigational product * Receipt of of insulin aspart within 3 months prior to trial participation

Design outcomes

Primary

MeasureTime frame
HbA1cafter 26 weeks of treatment

Secondary

MeasureTime frame
Overall glycaemic control—
Occurrence of adverse events—
Occurrence of serious adverse events—
Frequency of hypoglycaemia episodes—
Quality of Life (QoL)—

Countries

Poland

Outcome results

None listed

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