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

This study has been completed.

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

Purpose

Condition	Intervention	Phase
Diabetes Mellitus, Insulin-Dependent	Drug: human insulin Drug: insulin lispro Drug: insulin aspart	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin lispro

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study

Further study details as provided by Novo Nordisk:

Estimated Enrollment:	300
Study Start Date:	June 2002

Eligibility

Criteria

Inclusion Criteria:

Pediatric patients with Type 1 diabetes for at least one year
HbA1c < 12%
Willing to administer at least 3 injections per day,
Willing to perform 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

Locations

United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Paula Hale, MD

Novo Nordisk

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	ANA-2126
Study First Received:	October 23, 2003
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00071448
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novo Nordisk:

Pediatric, diabetes
Diabetes Mellitus

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009