Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes (ACTION)

January 10, 2017 updated by: Novo Nordisk A/S

A Multicenter, Open-Label, Randomised Trial to Compare the Efficacy and Safety of NovoLog Mix 70/30 BID in Combination With Metformin and Pioglitazone to Metformin and Pioglitazone Alone in Insulin Naïve Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA). The purpose of this study is to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

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
      • Birmingham, Alabama, United States, 35235
        • Novo Nordisk Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85006
        • Novo Nordisk Investigational Site
    • Arkansas
      • Searcy, Arkansas, United States, 72143
        • Novo Nordisk Investigational Site
    • California
      • Burlingame, California, United States, 94010
        • Novo Nordisk Investigational Site
      • Chula Vista, California, United States, 91911
        • Novo Nordisk Investigational Site
      • Fullerton, California, United States, 92835
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Redwood City, California, United States, 94062
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80262
        • Novo Nordisk Investigational Site
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • Novo Nordisk Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Novo Nordisk Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Novo Nordisk Investigational Site
      • Fort Myers, Florida, United States, 33907
        • Novo Nordisk Investigational Site
      • Hollywood, Florida, United States, 33021
        • Novo Nordisk Investigational Site
      • Lake Mary, Florida, United States, 32746
        • Novo Nordisk Investigational Site
      • Melbourne, Florida, United States, 32901
        • Novo Nordisk Investigational Site
      • Ocala, Florida, United States, 34471
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • Novo Nordisk Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Novo Nordisk Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Novo Nordisk Investigational Site
      • Columbus, Georgia, United States, 31904
        • Novo Nordisk Investigational Site
      • Savannah, Georgia, United States, 31406
        • Novo Nordisk Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
      • Wichita, Kansas, United States, 67205
        • Novo Nordisk Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Novo Nordisk Investigational Site
    • Maryland
      • Easton, Maryland, United States, 21601
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Danvers, Massachusetts, United States, 01923
        • Novo Nordisk Investigational Site
      • Salisbury, Massachusetts, United States, 01952
        • Novo Nordisk Investigational Site
      • Waltham, Massachusetts, United States, 02453
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Novo Nordisk Investigational Site
      • Grand Rapids, Michigan, United States, 49506
        • Novo Nordisk Investigational Site
      • Livonia, Michigan, United States, 48152
        • Novo Nordisk Investigational Site
    • Minnesota
      • St. Cloud, Minnesota, United States, 56303
        • Novo Nordisk Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89030
        • Novo Nordisk Investigational Site
      • Reno, Nevada, United States, 89502-0111
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Hampton, New Hampshire, United States, 03842
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Turnersville, New Jersey, United States, 08012
        • Novo Nordisk Investigational Site
    • New York
      • East Syracuse, New York, United States, 13057
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10003
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10023
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43203
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45406
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97501
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Melrose Park, Pennsylvania, United States, 19027
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76014
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75235
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Novo Nordisk Investigational Site
      • Irving, Texas, United States, 75061
        • Novo Nordisk Investigational Site
      • Midland, Texas, United States, 79707
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
    • Utah
      • Ogden, Utah, United States, 84403
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
      • Norfolk, Virginia, United States, 23507
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, United States, 23249
        • Novo Nordisk Investigational Site
      • Suffolk, Virginia, United States, 23434
        • Novo Nordisk Investigational Site
      • Warrenton, Virginia, United States, 20186
        • Novo Nordisk Investigational Site
    • Washington
      • Kirkland, Washington, United States, 98034
        • Novo Nordisk Investigational Site
      • Olympia, Washington, United States, 98502
        • Novo Nordisk Investigational Site
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
      • Tacoma, Washington, United States, 98405
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with type 2 diabetes mellitus

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 24 weeks
After 24 weeks

Secondary Outcome Measures

Outcome Measure
Safety variables
Other glycemic variables
8-point plasma glucose profiles

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

August 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

November 19, 2004

First Submitted That Met QC Criteria

November 19, 2004

First Posted (Estimate)

November 22, 2004

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-2186

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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