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

NCT ID: NCT00071448

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-06-30

Brief Summary

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This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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insulin human

Intervention Type DRUG

insulin lispro

Intervention Type DRUG

insulin aspart

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Loma Linda, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Englewood, Colorado, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Gainesville, Florida, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Idaho Falls, Idaho, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Baton Rouge, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Hackensack, New Jersey, United States

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Morristown, New Jersey, United States

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Paterson, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Akron, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Portland, Oregon, United States

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Danville, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Greer, South Carolina, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Lackland City, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Salt Lake City, Utah, United States

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Norfolk, Virginia, United States

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Spokane, Washington, United States

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Morgantown, West Virginia, United States

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Madison, Wisconsin, United States

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Countries

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United States

References

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Arslanian S, Foster C, Wright N, Stender S, Hu P, Hale P, Hale D. Comparison of Insulin Aspart, Regular Insulin, and Insulin Lispro in Basal Bolus Therapy with NPH To Treat Pediatric Patients with Type 1 Diabetes Mellitus. Diabetes 2005; 54 ((suppl 1)): A517 [Abstract 2150-PO]

Reference Type RESULT

Arslanian S, Foster C, Wright NM, Stender S, Hale P, Hale D. Insulin apart compared to regular insulin and insulin lispro in basal bolus therapy with NPH to treat pediatric patients with type 1 diabetes mellitus. EASD 2005 2005; 48(Suppl. 1): A327

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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ANA-2126

Identifier Type: -

Identifier Source: org_study_id