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

December 21, 2016 updated by: Novo Nordisk A/S

Basal/Bolus Therapy With Insulin Aspart (NovoLog®) Versus Regular Human Insulin (Novolin® R) or Insulin Lispro (Humalog®) in Combination With NPH: An Open-Label, Randomized, Parallel Group, Multicenter Study in Children and Adolescents With Type 1 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

378

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Novo Nordisk Investigational Site
      • Mobile, Alabama, United States, 36617
        • Novo Nordisk Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85712
        • Novo Nordisk Investigational Site
    • California
      • Loma Linda, California, United States, 92354
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90806
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90027
        • Novo Nordisk Investigational Site
      • Sacramento, California, United States, 95817
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92123
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92093
        • Novo Nordisk Investigational Site
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Novo Nordisk Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Novo Nordisk Investigational Site
      • New Haven, Connecticut, United States, 06520
        • Novo Nordisk Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32608
        • Novo Nordisk Investigational Site
      • Gainesville, Florida, United States, 32605
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32806-1101
        • Novo Nordisk Investigational Site
      • Pensacola, Florida, United States, 32504
        • Novo Nordisk Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33612
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202-2879
        • Novo Nordisk Investigational Site
      • Indianapolis, Indiana, United States, 46250
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Novo Nordisk Investigational Site
      • New Orleans, Louisiana, United States, 70127-5430
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Novo Nordisk Investigational Site
      • Baltimore, Maryland, United States, 21201
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Novo Nordisk Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Novo Nordisk Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • Novo Nordisk Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Novo Nordisk Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Novo Nordisk Investigational Site
      • Rochester, Minnesota, United States, 55905
        • Novo Nordisk Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
      • Omaha, Nebraska, United States, 68198-3020
        • Novo Nordisk Investigational Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Novo Nordisk Investigational Site
      • Morristown, New Jersey, United States, 07962
        • Novo Nordisk Investigational Site
      • Paterson, New Jersey, United States, 07503
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Novo Nordisk Investigational Site
      • Brooklyn, New York, United States, 11219
        • Novo Nordisk Investigational Site
      • Buffalo, New York, United States, 53226
        • Novo Nordisk Investigational Site
      • Mineola, New York, United States, 11501
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10029
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10022
        • Novo Nordisk Investigational Site
      • Rochester, New York, United States, 14642
        • Novo Nordisk Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7220
        • Novo Nordisk Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43231
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45404
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97227
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Novo Nordisk Investigational Site
      • Erie, Pennsylvania, United States, 16507
        • Novo Nordisk Investigational Site
      • Hershey, Pennsylvania, United States, 17033
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213-3417
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novo Nordisk Investigational Site
      • Columbia, South Carolina, United States, 29203
        • Novo Nordisk Investigational Site
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Novo Nordisk Investigational Site
      • Memphis, Tennessee, United States, 38103
        • Novo Nordisk Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75235
        • Novo Nordisk Investigational Site
      • Lackland, Texas, United States, 78236
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78284
        • Novo Nordisk Investigational Site
      • Temple, Texas, United States, 76508
        • Novo Nordisk Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Novo Nordisk Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99201
        • Novo Nordisk Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c (glycosylated haemoglobin A1c)

Secondary Outcome Measures

Outcome Measure
FPG (fasting plasma glucose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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]
  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (ACTUAL)

June 1, 2004

Study Completion (ACTUAL)

June 1, 2004

Study Registration Dates

First Submitted

October 23, 2003

First Submitted That Met QC Criteria

October 23, 2003

First Posted (ESTIMATE)

October 24, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA-2126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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