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

NCT00097071 | Completed Phase 3

• 1 other identifier: ANA-2181
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 52

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Keywords

Diabetes, Type 1

Outcome Measures

Primary Outcomes (1)

• HbA1c

  After 16 weeks treatment

Secondary Outcomes (1)

• Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events

Interventions

insulin lispro DRUG

insulin aspart DRUG

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Type 1 Diabetes

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (52)

Novo Nordisk Investigational Site

Mobile, Alabama, 36617, United States

Location

Novo Nordisk Investigational Site

Montgomery, Alabama, 36106, United States

Location

Novo Nordisk Investigational Site

Phoenix, Arizona, 85016, United States

Location

Novo Nordisk Investigational Site

Little Rock, Arkansas, 72202, United States

Location

Novo Nordisk Investigational Site

Loma Linda, California, 92354, United States

Location

Novo Nordisk Investigational Site

Sacramento, California, 95816, United States

Location

Novo Nordisk Investigational Site

San Diego, California, 92123, United States

Location

Novo Nordisk Investigational Site

Denver, Colorado, 80262, United States

Location

Novo Nordisk Investigational Site

Englewood, Colorado, 80110, United States

Location

Novo Nordisk Investigational Site

New Haven, Connecticut, 06520, United States

Location

Novo Nordisk Investigational Site

Orlando, Florida, 32806-1101, United States

Location

Novo Nordisk Investigational Site

St. Petersburg, Florida, 33701, United States

Location

Novo Nordisk Investigational Site

Tallahassee, Florida, 32308, United States

Location

Novo Nordisk Investigational Site

Atlanta, Georgia, 30318, United States

Location

Novo Nordisk Investigational Site

Idaho Falls, Idaho, 83404-7596, United States

Location

Novo Nordisk Investigational Site

Indianapolis, Indiana, 46202-2879, United States

Location

Novo Nordisk Investigational Site

Iowa City, Iowa, 52242, United States

Location

Novo Nordisk Investigational Site

Topeka, Kansas, 66606, United States

Location

Novo Nordisk Investigational Site

Wichita, Kansas, 67226, United States

Location

Novo Nordisk Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

Novo Nordisk Investigational Site

Baltimore, Maryland, 21229, United States

Location

Novo Nordisk Investigational Site

Baltimore, Maryland, 21287, United States

Location

Novo Nordisk Investigational Site

Boston, Massachusetts, 02115, United States

Location

Novo Nordisk Investigational Site

Boston, Massachusetts, 02215, United States

Location

Novo Nordisk Investigational Site

Springfield, Massachusetts, 01107, United States

Location

Novo Nordisk Investigational Site

Worcester, Massachusetts, 01655, United States

Location

Novo Nordisk Investigational Site

Detroit, Michigan, 48202-2689, United States

Location

Novo Nordisk Investigational Site

Minneapolis, Minnesota, 55416, United States

Location

Novo Nordisk Investigational Site

Minneapolis, Minnesota, 55455, United States

Location

Novo Nordisk Investigational Site

Kansas City, Missouri, 64108, United States

Location

Novo Nordisk Investigational Site

Omaha, Nebraska, 68114, United States

Location

Novo Nordisk Investigational Site

Omaha, Nebraska, 68198-3020, United States

Location

Novo Nordisk Investigational Site

Hackensack, New Jersey, 07601, United States

Location

Novo Nordisk Investigational Site

Brooklyn, New York, 11219, United States

Location

Novo Nordisk Investigational Site

Buffalo, New York, 14222, United States

Location

Novo Nordisk Investigational Site

Manhasset, New York, 11030, United States

Location

Novo Nordisk Investigational Site

The Bronx, New York, 10467, United States

Location

Novo Nordisk Investigational Site

Asheville, North Carolina, 28803, United States

Location

Novo Nordisk Investigational Site

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

Location

Novo Nordisk Investigational Site

Columbus, Ohio, 43203, United States

Location

Novo Nordisk Investigational Site

Tulsa, Oklahoma, 74136, United States

Location

Novo Nordisk Investigational Site

Portland, Oregon, 97239, United States

Location

Novo Nordisk Investigational Site

Hershey, Pennsylvania, 17033, United States

Location

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

Novo Nordisk Investigational Site

Pittsburgh, Pennsylvania, 15224, United States

Location

Novo Nordisk Investigational Site

Charleston, South Carolina, 29425, United States

Location

Novo Nordisk Investigational Site

San Antonio, Texas, 78229, United States

Location

Novo Nordisk Investigational Site

San Antonio, Texas, 78284, United States

Location

Novo Nordisk Investigational Site

Norfolk, Virginia, 23507, United States

Location

Novo Nordisk Investigational Site

Seattle, Washington, 98105, United States

Location

Novo Nordisk Investigational Site

Charleston, West Virginia, 25302, United States

Location

Novo Nordisk Investigational Site

Milwaukee, Wisconsin, 53226-0509, United States

Location

Related Publications (1)

• Weinzimer SA, Ternand C, Howard C, Chang CT, Becker DJ, Laffel LM; Insulin Aspart Pediatric Pump Study Group. A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes. Diabetes Care. 2008 Feb;31(2):210-5. doi: 10.2337/dc07-1378. Epub 2007 Nov 5.

  PMID: 17989308 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

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)

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

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: November 17, 2004
• First Posted: November 18, 2004
• Study Start: October 1, 2004
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

US (52)