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

December 21, 2016 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

299

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • Novo Nordisk Investigational Site
      • Montgomery, Alabama, United States, 36106
        • Novo Nordisk Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Novo Nordisk Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Novo Nordisk Investigational Site
    • California
      • Loma Linda, California, United States, 92354
        • Novo Nordisk Investigational Site
      • Sacramento, California, United States, 95816
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92123
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80262
        • Novo Nordisk Investigational Site
      • Englewood, Colorado, United States, 80110
        • Novo Nordisk Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Novo Nordisk Investigational Site
    • Florida
      • Orlando, Florida, United States, 32806-1101
        • Novo Nordisk Investigational Site
      • St. Petersburg, Florida, United States, 33701
        • Novo Nordisk Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202-2879
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
      • Wichita, Kansas, United States, 67226
        • Novo Nordisk Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Novo Nordisk Investigational Site
      • Baltimore, Maryland, United States, 21287
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Novo Nordisk Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Novo Nordisk Investigational Site
      • Springfield, Massachusetts, United States, 01107
        • Novo Nordisk Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
        • Novo Nordisk Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Novo Nordisk Investigational Site
      • Minneapolis, Minnesota, United States, 55455
        • Novo Nordisk Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
      • Omaha, Nebraska, United States, 68198-3020
        • Novo Nordisk Investigational Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Novo Nordisk Investigational Site
    • New York
      • Bronx, New York, United States, 10467
        • Novo Nordisk Investigational Site
      • Brooklyn, New York, United States, 11219
        • Novo Nordisk Investigational Site
      • Buffalo, New York, United States, 14222
        • Novo Nordisk Investigational Site
      • Manhasset, New York, United States, 11030
        • Novo Nordisk Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Novo Nordisk Investigational Site
      • Chapel Hill, North Carolina, United States, 27599-7220
        • Novo Nordisk Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43203
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novo Nordisk Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78284
        • Novo Nordisk Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Novo Nordisk Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Novo Nordisk Investigational Site
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-0509
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: After 16 weeks treatment
After 16 weeks treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

November 17, 2004

First Submitted That Met QC Criteria

November 17, 2004

First Posted (Estimate)

November 18, 2004

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA-2181

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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