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

This study has been completed.

First Received: October 23, 2003 Last Updated: May 12, 2009 History of Changes

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: human insulin Drug: insulin lispro Drug: insulin aspart	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin lispro

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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 < 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

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	ANA-2126
Study First Received:	October 23, 2003
Last Updated:	May 12, 2009
ClinicalTrials.gov Identifier:	NCT00071448 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novo Nordisk:

Pediatric, diabetes
Diabetes Mellitus

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Diabetes Mellitus Type 1
Insulin

Hypoglycemic Agents
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO

Insulin
Pharmacologic Actions
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009