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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: December 21, 2016
Last verified: December 2016
  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
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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin A1c)

Secondary Outcome Measures:
  • FPG (fasting plasma glucose)

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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 76 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
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

Responsible Party: 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: December 21, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 23, 2017