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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00097071
First received: November 17, 2004
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps 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 [ Time Frame: After 16 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events [ Designated as safety issue: No ]

Enrollment: 299
Study Start Date: October 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 Diabetes
  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: NCT00097071

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Mobile, Alabama, United States, 36617
Novo Nordisk Clinical Trial Call Center
Montgomery, Alabama, United States, 36106
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States, 85016
United States, Arkansas
Novo Nordisk Clinical Trial Call Center
Little Rock, Arkansas, United States, 72202
United States, California
Novo Nordisk Clinical Trial Call Center
Sacramento, California, United States, 95816
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92123
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Denver, Colorado, United States, 80262
Novo Nordisk Clinical Trial Call Center
Englewood, Colorado, United States, 80110
United States, Connecticut
Novo Nordisk Clinical Trial Call Center
New Haven, Connecticut, United States, 06520
United States, Florida
Novo Nordisk Clinical Trial Call Center
Orlando, Florida, United States, 32806-1101
Novo Nordisk Clinical Trial Call Center
St. Petersburg, Florida, United States, 33701
Novo Nordisk Clinical Trial Call Center
Tallahassee, Florida, United States, 32308
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30309
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, 46202-2879
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Iowa City, Iowa, United States, 52242
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Topeka, Kansas, United States, 66606
Novo Nordisk Clinical Trial Call Center
Wichita, Kansas, United States, 67211
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Baton Rouge, Louisiana, United States, 70808
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02115
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02215
Novo Nordisk Clinical Trial Call Center
Springfield, Massachusetts, United States, 01107
Novo Nordisk Clinical Trial Call Center
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Minneapolis, Minnesota, United States, 55416-2699
Novo Nordisk Clinical Trial Call Center
Minneapolis, Minnesota, United States, 55455
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
United States, New York
Novo Nordisk Clinical Trial Call Center
Bronx, New York, United States, 10467
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
Manhasset, New York, United States, 11030
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Asheville, North Carolina, United States, 28803
Novo Nordisk Clinical Trial Call Center
Chapel Hill, North Carolina, United States, 27599-7220
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Columbus, Ohio, United States, 43203
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97201
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Charleston, South Carolina, United States, 29425
United States, Texas
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78284
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229
United States, West Virginia
Novo Nordisk Clinical Trial Call Center
Charleston, West Virginia, United States, 25302
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Campbell Howard, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00097071     History of Changes
Other Study ID Numbers: ANA-2181
Study First Received: November 17, 2004
Last Updated: June 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novo Nordisk A/S:
Diabetes, Type 1

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
Insulin Lispro
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014