Clinical trial NCT00097279: Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2004-11-22
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes mellitus

Primary outcomes:
measure: HbA1c
timeFrame: After 24 weeks
Secondary outcomes:
measure: Safety variables
measure: Other glycemic variables
measure: 8-point plasma glucose profiles
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Searcy
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Burlingame
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Chula Vista
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fullerton
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Redwood City
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Denver
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: New Britain
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Newark
country: United States
facility: Novo Nordisk Investigational Site
state: Delaware
city: Aventura
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Lake Mary
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Ocala
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Boise
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Topeka
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Easton
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Danvers
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Salisbury
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Waltham
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Grand Rapids
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Livonia
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: St. Cloud
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Columbia
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Reno
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Hampton
country: United States
facility: Novo Nordisk Investigational Site
state: New Hampshire
city: Berlin
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Turnersville
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: East Syracuse
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Kettering
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Medford
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Melrose Park
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Irving
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Midland
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Ogden
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Newport News
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Suffolk
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Warrenton
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Kirkland
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Olympia
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Renton
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.