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NCT00097071 Clinical Trial

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

Diabetes Clinical Trial

Official title:
Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00097071
Other study ID # ANA-2181
Secondary ID
Status Completed
Phase Phase 3
First received November 17, 2004
Last updated December 21, 2016
Start date October 2004
Est. completion date May 2006

Study information
Verified date December 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 299
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria:

- Type 1 Diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• insulin lispro

• insulin aspart

Locations
Country Name City State
United States Novo Nordisk Investigational Site Asheville North Carolina
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Baton Rouge Louisiana
United States Novo Nordisk Investigational Site Boston Massachusetts
United States Novo Nordisk Investigational Site Boston Massachusetts
United States Novo Nordisk Investigational Site Bronx New York
United States Novo Nordisk Investigational Site Brooklyn New York
United States Novo Nordisk Investigational Site Buffalo New York
United States Novo Nordisk Investigational Site Chapel Hill North Carolina
United States Novo Nordisk Investigational Site Charleston South Carolina
United States Novo Nordisk Investigational Site Charleston West Virginia
United States Novo Nordisk Investigational Site Columbus Ohio
United States Novo Nordisk Investigational Site Denver Colorado
United States Novo Nordisk Investigational Site Detroit Michigan
United States Novo Nordisk Investigational Site Englewood Colorado
United States Novo Nordisk Investigational Site Hackensack New Jersey
United States Novo Nordisk Investigational Site Hershey Pennsylvania
United States Novo Nordisk Investigational Site Idaho Falls Idaho
United States Novo Nordisk Investigational Site Indianapolis Indiana
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Kansas City Missouri
United States Novo Nordisk Investigational Site Little Rock Arkansas
United States Novo Nordisk Investigational Site Loma Linda California
United States Novo Nordisk Investigational Site Manhasset New York
United States Novo Nordisk Investigational Site Milwaukee Wisconsin
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site Mobile Alabama
United States Novo Nordisk Investigational Site Montgomery Alabama
United States Novo Nordisk Investigational Site New Haven Connecticut
United States Novo Nordisk Investigational Site Norfolk Virginia
United States Novo Nordisk Investigational Site Omaha Nebraska
United States Novo Nordisk Investigational Site Omaha Nebraska
United States Novo Nordisk Investigational Site Orlando Florida
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Pittsburgh Pennsylvania
United States Novo Nordisk Investigational Site Portland Oregon
United States Novo Nordisk Investigational Site Sacramento California
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site Seattle Washington
United States Novo Nordisk Investigational Site Springfield Massachusetts
United States Novo Nordisk Investigational Site St. Petersburg Florida
United States Novo Nordisk Investigational Site Tallahassee Florida
United States Novo Nordisk Investigational Site Topeka Kansas
United States Novo Nordisk Investigational Site Tulsa Oklahoma
United States Novo Nordisk Investigational Site Wichita Kansas
United States Novo Nordisk Investigational Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & 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 t — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c After 16 weeks treatment No
Secondary Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events No
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