Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Efficacy and Safety Comparison of Insulin Detemir and Insulin Glargine Plus Insulin Aspart in Patients With Type 2 Diabetes
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted in the United States of America (USA). The purpose of this study is to determine if the use of insulin detemir in combination with insulin aspart is safe and at least as effective as insulin glargine in combination with insulin aspart for the control of blood glucose in patients with Type 2 diabetes.
| Status | Completed |
| Enrollment | 389 |
| Est. completion date | December 2005 |
| Est. primary completion date | December 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 Diabetes for more than 12 months - Currently treated with glucose lowering tablets or insulin - HbA1c: 7.0-12.0% |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Novo Nordisk Investigational Site | Calgary | Alberta |
| Canada | Novo Nordisk Investigational Site | Halifax | Nova Scotia |
| Canada | Novo Nordisk Investigational Site | Laval | Quebec |
| Canada | Novo Nordisk Investigational Site | London | |
| Canada | Novo Nordisk Investigational Site | Mississauga | |
| Canada | Novo Nordisk Investigational Site | Montreal | |
| Canada | Novo Nordisk Investigational Site | Ste-Foy | |
| Canada | Novo Nordisk Investigational Site | Thornhill | |
| Canada | Novo Nordisk Investigational Site | Toronto | Ontario |
| Puerto Rico | Novo Nordisk Investigational Site | Rio Piedras | |
| United States | Novo Nordisk Investigational Site | Arlington | Texas |
| United States | Novo Nordisk Investigational Site | Asheville | North Carolina |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Aurora | Colorado |
| United States | Novo Nordisk Investigational Site | Aventura | Florida |
| United States | Novo Nordisk Investigational Site | Baltimore | Maryland |
| United States | Novo Nordisk Investigational Site | Berlin | New Jersey |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Canton | Ohio |
| 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 | Clinton | Oklahoma |
| United States | Novo Nordisk Investigational Site | Concord | California |
| 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 | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Delray Beach | Florida |
| United States | Novo Nordisk Investigational Site | Des Moines | Iowa |
| United States | Novo Nordisk Investigational Site | Duncan | South Carolina |
| United States | Novo Nordisk Investigational Site | Franklin | Ohio |
| United States | Novo Nordisk Investigational Site | Greensboro | North Carolina |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Idaho Falls | Idaho |
| United States | Novo Nordisk Investigational Site | Inglewood | California |
| United States | Novo Nordisk Investigational Site | Kansas City | Missouri |
| United States | Novo Nordisk Investigational Site | Kettering | Ohio |
| United States | Novo Nordisk Investigational Site | Lake Mary | Florida |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Lawrenceville | New Jersey |
| United States | Novo Nordisk Investigational Site | Little Rock | Arkansas |
| United States | Novo Nordisk Investigational Site | Longmont | Colorado |
| United States | Novo Nordisk Investigational Site | Longwood | Florida |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Medford | Oregon |
| United States | Novo Nordisk Investigational Site | Mentor | Ohio |
| United States | Novo Nordisk Investigational Site | Midland | Texas |
| United States | Novo Nordisk Investigational Site | Monroe | North Carolina |
| United States | Novo Nordisk Investigational Site | Newark | Delaware |
| United States | Novo Nordisk Investigational Site | Newport News | Virginia |
| United States | Novo Nordisk Investigational Site | Ocala | Florida |
| United States | Novo Nordisk Investigational Site | Olympia | Washington |
| United States | Novo Nordisk Investigational Site | Orange | California |
| United States | Novo Nordisk Investigational Site | Orlando | Florida |
| United States | Novo Nordisk Investigational Site | Plano | Texas |
| United States | Novo Nordisk Investigational Site | Plantation | Florida |
| United States | Novo Nordisk Investigational Site | Powder Springs | Georgia |
| United States | Novo Nordisk Investigational Site | Raleigh | North Carolina |
| 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 | Richmond | Virginia |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | Santa Ana | California |
| United States | Novo Nordisk Investigational Site | Santa Barbara | California |
| United States | Novo Nordisk Investigational Site | Santa Monica | California |
| United States | Novo Nordisk Investigational Site | Searcy | Arkansas |
| United States | Novo Nordisk Investigational Site | Springfield | Illinois |
| United States | Novo Nordisk Investigational Site | St. Louis | Missouri |
| United States | Novo Nordisk Investigational Site | St. Paul | Minnesota |
| United States | Novo Nordisk Investigational Site | Tacoma | Washington |
| United States | Novo Nordisk Investigational Site | Topeka | Kansas |
| United States | Novo Nordisk Investigational Site | Tulsa | Oklahoma |
| United States | Novo Nordisk Investigational Site | Vestavia | Alabama |
| United States | Novo Nordisk Investigational Site | West Palm Beach | Florida |
| United States | Novo Nordisk Investigational Site | West Seneca | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Canada, Puerto Rico,
Raskin P, Gylvin T, Weng W, Chaykin L. Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes. Diabetes Metab Res Rev. 2009 Sep;25(6):542-8. doi: 10.1002/d — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | after 26 weeks | ||
| Secondary | Body weight | |||
| Secondary | Glucose profiles |
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