Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00071448
First received: October 23, 2003
Last updated: January 23, 2012
Last verified: January 2012
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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:
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
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| 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
Investigators
| Study Director: | Paula Hale, MD | Novo Nordisk |
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 May 23, 2013