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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00071448
First received: October 23, 2003
Last updated: October 23, 2014
Last verified: October 2014

October 23, 2003
October 23, 2014
June 2002
June 2004   (final data collection date for primary outcome measure)
HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00071448 on ClinicalTrials.gov Archive Site
FPG (fasting plasma glucose) [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin human
  • Drug: insulin lispro
  • Drug: insulin aspart
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
378
June 2004
June 2004   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00071448
ANA-2126
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP