Diabetes Mellitus, Type 2 Clinical Trial
— ACTIONOfficial title:
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
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 230 |
| Est. completion date | August 2005 |
| Est. primary completion date | August 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects with type 2 diabetes mellitus |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Novo Nordisk Investigational Site | Arlington | Texas |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Aventura | Florida |
| United States | Novo Nordisk Investigational Site | Baton Rouge | Louisiana |
| United States | Novo Nordisk Investigational Site | Berlin | New Jersey |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Boise | Idaho |
| United States | Novo Nordisk Investigational Site | Burlingame | California |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chula Vista | California |
| United States | Novo Nordisk Investigational Site | Columbia | Missouri |
| United States | Novo Nordisk Investigational Site | Columbus | Ohio |
| United States | Novo Nordisk Investigational Site | Columbus | Georgia |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Danvers | Massachusetts |
| United States | Novo Nordisk Investigational Site | Dayton | Ohio |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Detroit | Michigan |
| United States | Novo Nordisk Investigational Site | East Syracuse | New York |
| United States | Novo Nordisk Investigational Site | Easton | Maryland |
| United States | Novo Nordisk Investigational Site | Fort Myers | Florida |
| United States | Novo Nordisk Investigational Site | Fullerton | California |
| United States | Novo Nordisk Investigational Site | Glendale | Arizona |
| United States | Novo Nordisk Investigational Site | Grand Rapids | Michigan |
| United States | Novo Nordisk Investigational Site | Greenville | North Carolina |
| United States | Novo Nordisk Investigational Site | Greer | South Carolina |
| United States | Novo Nordisk Investigational Site | Hampton | New Hampshire |
| United States | Novo Nordisk Investigational Site | Hollywood | Florida |
| United States | Novo Nordisk Investigational Site | Irving | Texas |
| United States | Novo Nordisk Investigational Site | Kettering | Ohio |
| United States | Novo Nordisk Investigational Site | Kirkland | Washington |
| United States | Novo Nordisk Investigational Site | Lake Mary | Florida |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Livonia | Michigan |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Medford | Oregon |
| United States | Novo Nordisk Investigational Site | Melbourne | Florida |
| United States | Novo Nordisk Investigational Site | Melrose Park | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Midland | Texas |
| United States | Novo Nordisk Investigational Site | Milwaukee | Wisconsin |
| United States | Novo Nordisk Investigational Site | New Britain | Connecticut |
| United States | Novo Nordisk Investigational Site | New York | New York |
| United States | Novo Nordisk Investigational Site | New York | New York |
| United States | Novo Nordisk Investigational Site | Newark | Delaware |
| United States | Novo Nordisk Investigational Site | Newport News | Virginia |
| United States | Novo Nordisk Investigational Site | Norfolk | Virginia |
| United States | Novo Nordisk Investigational Site | Ocala | Florida |
| United States | Novo Nordisk Investigational Site | Ogden | Utah |
| United States | Novo Nordisk Investigational Site | Olympia | Washington |
| United States | Novo Nordisk Investigational Site | Pembroke Pines | Florida |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Redwood City | California |
| United States | Novo Nordisk Investigational Site | Reno | Nevada |
| United States | Novo Nordisk Investigational Site | Renton | Washington |
| United States | Novo Nordisk Investigational Site | Richmond | Virginia |
| United States | Novo Nordisk Investigational Site | Salisbury | Massachusetts |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | Savannah | Georgia |
| United States | Novo Nordisk Investigational Site | Searcy | Arkansas |
| United States | Novo Nordisk Investigational Site | St. Cloud | Minnesota |
| United States | Novo Nordisk Investigational Site | Suffolk | Virginia |
| United States | Novo Nordisk Investigational Site | Tacoma | Washington |
| United States | Novo Nordisk Investigational Site | Tallahassee | Florida |
| United States | Novo Nordisk Investigational Site | Topeka | Kansas |
| United States | Novo Nordisk Investigational Site | Turnersville | New Jersey |
| United States | Novo Nordisk Investigational Site | Waltham | Massachusetts |
| United States | Novo Nordisk Investigational Site | Warrenton | Virginia |
| United States | Novo Nordisk Investigational Site | West Palm Beach | Florida |
| United States | Novo Nordisk Investigational Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States,
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 ag — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | After 24 weeks | No | |
| Secondary | Safety variables | No | ||
| Secondary | Other glycemic variables | No | ||
| Secondary | 8-point plasma glucose profiles | No |
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