Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00071448

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin human Insulin aspart Insulin lispro

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 May 24, 2012