Clinical trial NCT00097877: Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Official title: Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Combination With Metformin in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2004-12-01
Enrollment: 293
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 twice a day with Metformin improves glycemic control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who are inadequately controlled on basal insulin plus oral anti-diabetic therapy.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes

Primary outcomes:
measure: HbA1c
timeFrame: After 24 weeks
Secondary outcomes:
measure: safety variables
measure: 8-point plasma glucose profile
measure: other glycemic variables
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Vestavia
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Searcy
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
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: Orange
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Orange
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: New Britain
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Chiefland
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
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: Plantation
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Atlanta
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: New Albany
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Overland Park
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Topeka
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Springfield
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Cherry Hill
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Lawrenceville
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Plainsboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: New Hyde Park
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Staten Island
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Syracuse
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Dayton
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: Clinton
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Salem
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Lancaster
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Melrose Park
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Memphis
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: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Lewisville
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Midland
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Plano
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Plano
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: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Warrenton
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Manati
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Santurce
country: Puerto Rico
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Ligthelm RJ, Gylvin T, DeLuzio T, Raskin P. A comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: a randomized, open-label study. Endocr Pract. 2011 Jan-Feb;17(1):41-50. doi: 10.4158/EP10079.OR.
citation: Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Deluzio AJ, Chu PL, Trippe BS; Initiateplus Study Group. Efficacy and tolerability of self-titrated biphasic insulin aspart 70/30 in patients aged >65 years with type 2 diabetes: an exploratory post hoc subanalysis of the INITIATEplus trial. Clin Ther. 2011 Jul;33(7):874-83. doi: 10.1016/j.clinthera.2011.05.093. Epub 2011 Jul 8.
citation: Trippe BS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Oyer DS. Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial). Curr Med Res Opin. 2012 Jul;28(7):1203-11. doi: 10.1185/03007995.2012.686444. Epub 2012 Jun 25.
citation: Bergenstal R, Lewin A, Bailey T, Chang D, Gylvin T, Roberts V; NovoLog Mix-vs.-Exenatide Study Group. Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea. Curr Med Res Opin. 2009 Jan;25(1):65-75. doi: 10.1185/03007990802597951.