Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes
ACTION
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
1 other identifier
interventional
230
1 country
73
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes
Started Aug 2004
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 19, 2004
CompletedFirst Posted
Study publicly available on registry
November 22, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedJanuary 11, 2017
January 1, 2017
1 year
November 19, 2004
January 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
After 24 weeks
Secondary Outcomes (3)
Safety variables
Other glycemic variables
8-point plasma glucose profiles
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with type 2 diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (73)
Novo Nordisk Investigational Site
Birmingham, Alabama, 35235, United States
Novo Nordisk Investigational Site
Glendale, Arizona, 85306, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, 85006, United States
Novo Nordisk Investigational Site
Searcy, Arkansas, 72143, United States
Novo Nordisk Investigational Site
Burlingame, California, 94010, United States
Novo Nordisk Investigational Site
Chula Vista, California, 91911, United States
Novo Nordisk Investigational Site
Fullerton, California, 92835, United States
Novo Nordisk Investigational Site
Los Angeles, California, 90057, United States
Novo Nordisk Investigational Site
Redwood City, California, 94062, United States
Novo Nordisk Investigational Site
Denver, Colorado, 80262, United States
Novo Nordisk Investigational Site
New Britain, Connecticut, 06050, United States
Novo Nordisk Investigational Site
Newark, Delaware, 19713, United States
Novo Nordisk Investigational Site
Aventura, Florida, 33180, United States
Novo Nordisk Investigational Site
Fort Myers, Florida, 33907, United States
Novo Nordisk Investigational Site
Hollywood, Florida, 33021, United States
Novo Nordisk Investigational Site
Lake Mary, Florida, 32746, United States
Novo Nordisk Investigational Site
Melbourne, Florida, 32901, United States
Novo Nordisk Investigational Site
Ocala, Florida, 34471, United States
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33024, United States
Novo Nordisk Investigational Site
Tallahassee, Florida, 32308, United States
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33401, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, 30339, United States
Novo Nordisk Investigational Site
Columbus, Georgia, 31904, United States
Novo Nordisk Investigational Site
Savannah, Georgia, 31406, United States
Novo Nordisk Investigational Site
Boise, Idaho, 83702, United States
Novo Nordisk Investigational Site
Chicago, Illinois, 60607, United States
Novo Nordisk Investigational Site
Topeka, Kansas, 66606, United States
Novo Nordisk Investigational Site
Wichita, Kansas, 67205, United States
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, 70808, United States
Novo Nordisk Investigational Site
Easton, Maryland, 21601, United States
Novo Nordisk Investigational Site
Danvers, Massachusetts, 01923, United States
Novo Nordisk Investigational Site
Salisbury, Massachusetts, 01952, United States
Novo Nordisk Investigational Site
Waltham, Massachusetts, 02453, United States
Novo Nordisk Investigational Site
Detroit, Michigan, 48235, United States
Novo Nordisk Investigational Site
Grand Rapids, Michigan, 49506, United States
Novo Nordisk Investigational Site
Livonia, Michigan, 48152, United States
Novo Nordisk Investigational Site
Saint Cloud, Minnesota, 56303, United States
Novo Nordisk Investigational Site
Columbia, Missouri, 65212, United States
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89030, United States
Novo Nordisk Investigational Site
Reno, Nevada, 89502-0111, United States
Novo Nordisk Investigational Site
Hampton, New Hampshire, 03842, United States
Novo Nordisk Investigational Site
Berlin, New Jersey, 08009, United States
Novo Nordisk Investigational Site
Turnersville, New Jersey, 08012, United States
Novo Nordisk Investigational Site
East Syracuse, New York, 13057, United States
Novo Nordisk Investigational Site
New York, New York, 10003, United States
Novo Nordisk Investigational Site
New York, New York, 10023, United States
Novo Nordisk Investigational Site
Greenville, North Carolina, 27834, United States
Novo Nordisk Investigational Site
Columbus, Ohio, 43203, United States
Novo Nordisk Investigational Site
Dayton, Ohio, 45406, United States
Novo Nordisk Investigational Site
Kettering, Ohio, 45429, United States
Novo Nordisk Investigational Site
Medford, Oregon, 97501, United States
Novo Nordisk Investigational Site
Melrose Park, Pennsylvania, 19027, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107, United States
Novo Nordisk Investigational Site
Greer, South Carolina, 29651, United States
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404, United States
Novo Nordisk Investigational Site
Arlington, Texas, 76014, United States
Novo Nordisk Investigational Site
Dallas, Texas, 75231, United States
Novo Nordisk Investigational Site
Dallas, Texas, 75235, United States
Novo Nordisk Investigational Site
Dallas, Texas, 75390-8858, United States
Novo Nordisk Investigational Site
Irving, Texas, 75061, United States
Novo Nordisk Investigational Site
Midland, Texas, 79707, United States
Novo Nordisk Investigational Site
San Antonio, Texas, 78229, United States
Novo Nordisk Investigational Site
Ogden, Utah, 84403, United States
Novo Nordisk Investigational Site
Newport News, Virginia, 23606, United States
Novo Nordisk Investigational Site
Norfolk, Virginia, 23507, United States
Novo Nordisk Investigational Site
Richmond, Virginia, 23249, United States
Novo Nordisk Investigational Site
Suffolk, Virginia, 23434, United States
Novo Nordisk Investigational Site
Warrenton, Virginia, 20186, United States
Novo Nordisk Investigational Site
Kirkland, Washington, 98034, United States
Novo Nordisk Investigational Site
Olympia, Washington, 98502, United States
Novo Nordisk Investigational Site
Renton, Washington, 98057, United States
Novo Nordisk Investigational Site
Tacoma, Washington, 98405, United States
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209, United States
Related Publications (1)
Raskin P, Matfin G, Schwartz SL, Chaykin L, Chu PL, Braceras R, Wynne A. Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: The ACTION Study (Achieving Control Through Insulin plus Oral ageNts). Diabetes Obes Metab. 2009 Jan;11(1):27-32. doi: 10.1111/j.1463-1326.2007.00796.x. Epub 2007 Oct 17.
PMID: 17941873RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
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 19, 2004
First Posted
November 22, 2004
Study Start
August 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
January 11, 2017
Record last verified: 2017-01