Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Pediatric Population - Tabular View

Tracking Information

First Received Date ^ICMJE

October 23, 2003

Last Updated Date

October 14, 2009

Start Date ^ICMJE

June 2002

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00071448 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study

Condition ^ICMJE

Diabetes Mellitus, Insulin-Dependent

Intervention ^ICMJE

Drug: human insulin
Drug: insulin lispro
Drug: insulin aspart

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

378

Completion Date

June 2004

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00071448

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

ANA-2126

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Paula Hale, MD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP