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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00071448
First received: October 23, 2003
Last updated: December 21, 2016
Last verified: December 2016
  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
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)

Secondary Outcome Measures:
  • FPG (fasting plasma glucose)

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   (Child, Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35294
Novo Nordisk Investigational Site
Mobile, Alabama, United States, 36617
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85013
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85712
United States, California
Novo Nordisk Investigational Site
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, 92093
Novo Nordisk Investigational Site
San Diego, California, United States, 92123
United States, Colorado
Novo Nordisk Investigational Site
Englewood, Colorado, United States, 80110
United States, Connecticut
Novo Nordisk Investigational Site
Hartford, Connecticut, United States, 06106
Novo Nordisk Investigational Site
New Haven, Connecticut, United States, 06520
United States, Florida
Novo Nordisk Investigational Site
Gainesville, Florida, United States, 32605
Novo Nordisk Investigational Site
Gainesville, Florida, United States, 32608
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
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30342
United States, Idaho
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States, 83404-7596
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46202-2879
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46250
United States, Iowa
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
United States, Louisiana
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, United States, 70808
Novo Nordisk Investigational Site
New Orleans, Louisiana, United States, 70127-5430
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21201
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02115
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02215
Novo Nordisk Investigational Site
Worcester, Massachusetts, United States, 01655
United States, Michigan
Novo Nordisk Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55416
Novo Nordisk Investigational Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Novo Nordisk Investigational Site
Kansas City, Missouri, United States, 64108
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68198-3020
United States, New Jersey
Novo Nordisk Investigational Site
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
United States, New Mexico
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Novo Nordisk Investigational Site
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, 10022
Novo Nordisk Investigational Site
New York, New York, United States, 10029
Novo Nordisk Investigational Site
Rochester, New York, United States, 14642
United States, North Carolina
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27599-7220
United States, Ohio
Novo Nordisk Investigational Site
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
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97227
United States, Pennsylvania
Novo Nordisk Investigational Site
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
United States, South Carolina
Novo Nordisk Investigational Site
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
United States, Tennessee
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38103
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Novo Nordisk Investigational Site
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
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
Novo Nordisk Investigational Site
Norfolk, Virginia, United States, 23510
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99201
United States, West Virginia
Novo Nordisk Investigational Site
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Novo Nordisk Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
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

Responsible Party: 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: December 21, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Lispro
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2017