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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00071448
First received: October 23, 2003
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: insulin human
Drug: insulin lispro
Drug: insulin aspart
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FPG (fasting plasma glucose) [ Designated as safety issue: No ]

Enrollment: 378
Study Start Date: June 2002
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071448

  Show 67 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Paula Hale, MD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00071448     History of Changes
Other Study ID Numbers: ANA-2126
Study First Received: October 23, 2003
Last Updated: January 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013