Insulin Aspart Vs. Insulin Lispro Vs. Regular Insulin in Pediatric Population - Full Text View

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

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

Condition	Intervention	Phase
Diabetes Mellitus, Insulin-Dependent	Drug: Insulin Aspart (NovoLog®) Drug: Regular Human Insulin (Novolin®R) Drug: Insulin Lispro (Humalog®) in combination with NPH	Phase III

MedlinePlus related topics:

Diabetes Diabetes Type 1

ChemIDplus related topics:

Insulin Insulin aspart Insulin lispro

U.S. FDA Resources

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
Estimated Study Completion Date:	November 2003

Eligibility

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 Call Center
	Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Paula Hale, MD	Novo Nordisk

More Information

Study ID Numbers:	ANA-2126
First Received:	October 23, 2003
Last Updated:	December 9, 2005
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 September 05, 2008