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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00071448
Recruitment Status : Completed
First Posted : October 24, 2003
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin human Drug: insulin lispro Drug: insulin aspart Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2002
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin A1c)

Secondary Outcome Measures :
  1. FPG (fasting plasma glucose)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071448


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:
Arslanian S, Foster C, Wright N, Stender S, Hu P, Hale P, Hale D. Comparison of Insulin Aspart, Regular Insulin, and Insulin Lispro in Basal Bolus Therapy with NPH To Treat Pediatric Patients with Type 1 Diabetes Mellitus. Diabetes 2005; 54 ((suppl 1)): A517 [Abstract 2150-PO]
Arslanian S, Foster C, Wright NM, Stender S, Hale P, Hale D. Insulin apart compared to regular insulin and insulin lispro in basal bolus therapy with NPH to treat pediatric patients with type 1 diabetes mellitus. EASD 2005 2005; 48(Suppl. 1): A327

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00071448    
Other Study ID Numbers: ANA-2126
First Posted: October 24, 2003    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs