Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents

NCT ID: NCT00097071

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 1

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diabetes, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

insulin lispro

Intervention Type DRUG

insulin aspart

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 1 Diabetes
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Mobile, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Montgomery, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Little Rock, Arkansas, United States

Site Status

Novo Nordisk Investigational Site

Loma Linda, California, United States

Site Status

Novo Nordisk Investigational Site

Sacramento, California, United States

Site Status

Novo Nordisk Investigational Site

San Diego, California, United States

Site Status

Novo Nordisk Investigational Site

Denver, Colorado, United States

Site Status

Novo Nordisk Investigational Site

Englewood, Colorado, United States

Site Status

Novo Nordisk Investigational Site

New Haven, Connecticut, United States

Site Status

Novo Nordisk Investigational Site

Orlando, Florida, United States

Site Status

Novo Nordisk Investigational Site

St. Petersburg, Florida, United States

Site Status

Novo Nordisk Investigational Site

Tallahassee, Florida, United States

Site Status

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Idaho Falls, Idaho, United States

Site Status

Novo Nordisk Investigational Site

Indianapolis, Indiana, United States

Site Status

Novo Nordisk Investigational Site

Iowa City, Iowa, United States

Site Status

Novo Nordisk Investigational Site

Topeka, Kansas, United States

Site Status

Novo Nordisk Investigational Site

Wichita, Kansas, United States

Site Status

Novo Nordisk Investigational Site

Baton Rouge, Louisiana, United States

Site Status

Novo Nordisk Investigational Site

Baltimore, Maryland, United States

Site Status

Novo Nordisk Investigational Site

Baltimore, Maryland, United States

Site Status

Novo Nordisk Investigational Site

Boston, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Boston, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Springfield, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Worcester, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Detroit, Michigan, United States

Site Status

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States

Site Status

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States

Site Status

Novo Nordisk Investigational Site

Kansas City, Missouri, United States

Site Status

Novo Nordisk Investigational Site

Omaha, Nebraska, United States

Site Status

Novo Nordisk Investigational Site

Omaha, Nebraska, United States

Site Status

Novo Nordisk Investigational Site

Hackensack, New Jersey, United States

Site Status

Novo Nordisk Investigational Site

Brooklyn, New York, United States

Site Status

Novo Nordisk Investigational Site

Buffalo, New York, United States

Site Status

Novo Nordisk Investigational Site

Manhasset, New York, United States

Site Status

Novo Nordisk Investigational Site

The Bronx, New York, United States

Site Status

Novo Nordisk Investigational Site

Asheville, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Chapel Hill, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Columbus, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Tulsa, Oklahoma, United States

Site Status

Novo Nordisk Investigational Site

Portland, Oregon, United States

Site Status

Novo Nordisk Investigational Site

Hershey, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Charleston, South Carolina, United States

Site Status

Novo Nordisk Investigational Site

San Antonio, Texas, United States

Site Status

Novo Nordisk Investigational Site

San Antonio, Texas, United States

Site Status

Novo Nordisk Investigational Site

Norfolk, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Seattle, Washington, United States

Site Status

Novo Nordisk Investigational Site

Charleston, West Virginia, United States

Site Status

Novo Nordisk Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Weinzimer SA, Ternand C, Howard C, Chang CT, Becker DJ, Laffel LM; Insulin Aspart Pediatric Pump Study Group. A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes. Diabetes Care. 2008 Feb;31(2):210-5. doi: 10.2337/dc07-1378. Epub 2007 Nov 5.

Reference Type RESULT
PMID: 17989308 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANA-2181

Identifier Type: -

Identifier Source: org_study_id