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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00071448
First received: October 23, 2003
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin human
Drug: insulin lispro
Drug: insulin aspart
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FPG (fasting plasma glucose) [ Designated as safety issue: No ]

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071448

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Birmingham, Alabama, United States, 35294
Novo Nordisk Clinical Trial Call Center
Mobile, Alabama, United States, 36617
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States, 85013
United States, California
Novo Nordisk Clinical Trial Call Center
Loma Linda, California, United States, 92354
Novo Nordisk Clinical Trial Call Center
Long Beach, California, United States, 90806
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90027
Novo Nordisk Clinical Trial Call Center
Sacramento, California, United States, 95817
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92123
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92093
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Englewood, Colorado, United States, 80110
United States, Connecticut
Novo Nordisk Clinical Trial Call Center
Hartford, Connecticut, United States, 06106
United States, Florida
Novo Nordisk Clinical Trial Call Center
Gainesville, Florida, United States, 32608
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33101
Novo Nordisk Clinical Trial Call Center
Orlando, Florida, United States, 32806-1101
Novo Nordisk Clinical Trial Call Center
Pensacola, Florida, United States, 32504
Novo Nordisk Clinical Trial Call Center
Tampa, Florida, United States, 33606
United States, Idaho
Novo Nordisk Clinical Trial Call Center
Idaho Falls, Idaho, United States, 83404-7542
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46250
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46202-2879
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Iowa City, Iowa, United States, 52242
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Baton Rouge, Louisiana, United States, 70808
Novo Nordisk Clinical Trial Call Center
New Orleans, Louisiana, United States, 70127-5430
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21201
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02215
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02115
Novo Nordisk Clinical Trial Call Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Minneapolis, Minnesota, United States, 55416-2699
Novo Nordisk Clinical Trial Call Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Kansas City, Missouri, United States, 64108
United States, Nebraska
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States, 68114
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States, 68198-3020
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Hackensack, New Jersey, United States, 07601
Novo Nordisk Clinical Trial Call Center
Hillsborough, New Jersey, United States, 08844
Novo Nordisk Clinical Trial Call Center
Morristown, New Jersey, United States, 07962
Novo Nordisk Clinical Trial Call Center
Paterson, New Jersey, United States, 07503
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
United States, New York
Novo Nordisk Clinical Trial Call Center
Albany, New York, United States, 12208
Novo Nordisk Clinical Trial Call Center
Brooklyn, New York, United States, 11219
Novo Nordisk Clinical Trial Call Center
Buffalo, New York, United States, 14222
Novo Nordisk Clinical Trial Call Center
Mineola, New York, United States, 11501
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10021
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10022
Novo Nordisk Clinical Trial Call Center
Rochester, New York, United States, 14621
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Chapel Hill, North Carolina, United States, 27599-7220
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, United States, 44195
Novo Nordisk Clinical Trial Call Center
Columbus, Ohio, United States, 43231
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45404
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97227
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States, 15213-3417
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Charleston, South Carolina, United States, 29425
Novo Nordisk Clinical Trial Call Center
Columbia, South Carolina, United States, 29203
Novo Nordisk Clinical Trial Call Center
Greer, South Carolina, United States, 29651
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, United States, 38103
Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, United States, 38119
United States, Texas
Novo Nordisk Clinical Trial Call Center
Corpus Christi, Texas, United States, 78411
Novo Nordisk Clinical Trial Call Center
Lackland Afb, Texas, United States, 78236
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78284
Novo Nordisk Clinical Trial Call Center
Temple, Texas, United States, 76508
United States, Utah
Novo Nordisk Clinical Trial Call Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23510
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23507
United States, West Virginia
Novo Nordisk Clinical Trial Call Center
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Paula Hale, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00071448     History of Changes
Other Study ID Numbers: ANA-2126
Study First Received: October 23, 2003
Last Updated: January 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin aspart
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014