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

NCT00071448 | Completed Phase 3

• 1 other identifier: ANA-2126
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 76

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• HbA1c (glycosylated haemoglobin A1c)

Secondary Outcomes (1)

• FPG (fasting plasma glucose)

Interventions

insulin human DRUG

insulin lispro DRUG

insulin aspart DRUG

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (76)

Novo Nordisk Investigational Site

Birmingham, Alabama, 35294, United States

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Novo Nordisk Investigational Site

Mobile, Alabama, 36617, United States

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Novo Nordisk Investigational Site

Phoenix, Arizona, 85013, United States

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Tucson, Arizona, 85712, United States

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Loma Linda, California, 92354, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90027, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92093, United States

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San Diego, California, 92123, United States

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Englewood, Colorado, 80110, United States

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Hartford, Connecticut, 06106, United States

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New Haven, Connecticut, 06520, United States

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Gainesville, Florida, 32605, United States

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Gainesville, Florida, 32608, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32806-1101, United States

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Pensacola, Florida, 32504, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33612, United States

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Atlanta, Georgia, 30342, United States

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Idaho Falls, Idaho, 83404-7596, United States

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Indianapolis, Indiana, 46202-2879, United States

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Indianapolis, Indiana, 46250, United States

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Iowa City, Iowa, 52242, United States

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Baton Rouge, Louisiana, 70808, United States

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New Orleans, Louisiana, 70127-5430, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21229, United States

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Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02215, United States

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Worcester, Massachusetts, 01655, United States

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Ann Arbor, Michigan, 48109, United States

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Minneapolis, Minnesota, 55416, United States

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Rochester, Minnesota, 55905, United States

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Kansas City, Missouri, 64108, United States

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Omaha, Nebraska, 68114, United States

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Omaha, Nebraska, 68198-3020, United States

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Hackensack, New Jersey, 07601, United States

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Morristown, New Jersey, 07962, United States

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Paterson, New Jersey, 07503, United States

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Albuquerque, New Mexico, 87102, United States

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Albany, New York, 12208, United States

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Brooklyn, New York, 11219, United States

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Buffalo, New York, 53226, United States

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Mineola, New York, 11501, United States

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New York, New York, 10022, United States

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New York, New York, 10029, United States

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Rochester, New York, 14642, United States

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Chapel Hill, North Carolina, 27599-7220, United States

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Akron, Ohio, 44308-1062, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43231, United States

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Dayton, Ohio, 45404, United States

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Portland, Oregon, 97227, United States

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Danville, Pennsylvania, 17822, United States

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Erie, Pennsylvania, 16507, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15213-3417, United States

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Charleston, South Carolina, 29425, United States

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Columbia, South Carolina, 29203, United States

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Greer, South Carolina, 29651, United States

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Memphis, Tennessee, 38103, United States

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Memphis, Tennessee, 38119, United States

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Corpus Christi, Texas, 78411, United States

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Dallas, Texas, 75235, United States

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Lackland City, Texas, 78236, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78284, United States

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Temple, Texas, 76508, United States

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Salt Lake City, Utah, 84132, United States

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Norfolk, Virginia, 23510, United States

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Spokane, Washington, 99201, United States

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Morgantown, West Virginia, 26506, United States

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Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• 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]

  RESULT

• 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

  RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin; Insulin Lispro; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2003
• First Posted: October 24, 2003
• Study Start: June 1, 2002
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

US (76)