Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone. |
|---|---|
| Condition | Diabetes Diabetes Mellitus, Type 2 |
| Intervention | Drug: liraglutide Drug: rosiglitazone Drug: metformin |
| Phase | Phase 3 |
| Sponsor | Novo Nordisk A/S |
| Responsible Party | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier | NCT00333151 |
| First Received | June 1, 2006 |
| Last Updated | June 19, 2012 |
| Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 1, 2006 |
|---|---|
| Last Updated Date | June 19, 2012 |
| Start Date | May 2006 |
| Estimated Primary Completion Date | August 2007 |
| Current Primary Outcome Measures | HbA1c [Time Frame: after 26 weeks of treatment] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes |
|---|---|
| Official Title | Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes |
| Brief Summary | This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: liraglutide Drug: rosiglitazone Drug: metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 576 |
| Estimated Completion Date | August 2007 |
| Estimated Primary Completion Date | August 2007 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes - Treated with oral anti-diabetic (OAD) drugs for at least 3 months - Treated with one or more OAD and in moderate to poor glycemic control - Body Mass Index (BMI) less than or equal to 45.0 kg/m2 Exclusion Criteria: - Treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the Investigator - Any serious medical condition - Treatment with any drug that could interfere with glucose level |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00333151 |
|---|---|
| Other Study ID Numbers | NN2211-1574 |
| Has Data Monitoring Committee | No |
| Information Provided By | Novo Nordisk A/S |
| Study Sponsor | Novo Nordisk A/S |
| Collaborators | Not Provided |
| Investigators | Study Director: Paula Hale, MD Novo Nordisk A/S |
| Verification Date | June 2012 |
Locations[ + expand ][ + ]
| Novo Nordisk Clinical Trial Call Center | Goodyear, Arizona, United States, 85395 |
|---|---|
| Novo Nordisk Clinical Trial Call Center | Colton, California, United States, 92324 |
| Novo Nordisk Clinical Trial Call Center | Concord, California, United States, 94520 |
| Novo Nordisk Clinical Trial Call Center | Escondido, California, United States, 92026 |
| Novo Nordisk Clinical Trial Call Center | La Jolla, California, United States, 92037 |
| Novo Nordisk Clinical Trial Call Center | Long Beach, California, United States, 90822 |
| Novo Nordisk Clinical Trial Call Center | Los Angeles, California, United States, 90057 |
| Novo Nordisk Clinical Trial Call Center | Orange, California, United States, 92869 |
| Novo Nordisk Clinical Trial Call Center | Santa Ana, California, United States, 92705 |
| Novo Nordisk Clinical Trial Call Center | Santa Barbara, California, United States, 93105 |
| Novo Nordisk Clinical Trial Call Center | Spring Valley, California, United States, 91978 |
| Novo Nordisk Clinical Trial Call Center | New Britain, Connecticut, United States, 06050 |
| Novo Nordisk Clinical Trial Call Center | Washington, District of Columbia, United States, 20010 |
| Novo Nordisk Clinical Trial Call Center | Fort Myers, Florida, United States, 33907 |
| Novo Nordisk Clinical Trial Call Center | Jacksonville, Florida, United States, 32204 |
| Novo Nordisk Clinical Trial Call Center | Lake Mary, Florida, United States, 32746 |
| Novo Nordisk Clinical Trial Call Center | Plantation, Florida, United States, 33324 |
| Novo Nordisk Clinical Trial Call Center | Athens, Georgia, United States, 30606 |
| Novo Nordisk Clinical Trial Call Center | Atlanta, Georgia, United States, 30309 |
| Novo Nordisk Clinical Trial Call Center | Powder Springs, Georgia, United States, 30127 |
| Novo Nordisk Clinical Trial Call Center | Idaho Falls, Idaho, United States, 83404-7542 |
| Novo Nordisk Clinical Trial Call Center | Peoria, Illinois, United States, 61615 |
| Novo Nordisk Clinical Trial Call Center | New Albany, Indiana, United States, 47150 |
| Novo Nordisk Clinical Trial Call Center | Des Moines, Iowa, United States, 50314 |
| Novo Nordisk Clinical Trial Call Center | Topeka, Kansas, United States, 66606 |
| Novo Nordisk Clinical Trial Call Center | Lexington, Kentucky, United States, 40503 |
| Novo Nordisk Clinical Trial Call Center | Baton Rouge, Louisiana, United States, 70808 |
| Novo Nordisk Clinical Trial Call Center | New Orleans, Louisiana, United States, 70121 |
| Novo Nordisk Clinical Trial Call Center | Hyattsville, Maryland, United States, 20782 |
| Novo Nordisk Clinical Trial Call Center | Tupelo, Mississippi, United States, 38801 |
| Novo Nordisk Clinical Trial Call Center | St. Louis, Missouri, United States, 63110 |
| Novo Nordisk Clinical Trial Call Center | Las Vegas, Nevada, United States, 89103 |
| Novo Nordisk Clinical Trial Call Center | Berlin, New Jersey, United States, 08009 |
| Novo Nordisk Clinical Trial Call Center | Princeton, New Jersey, United States, 08540 |
| Novo Nordisk Clinical Trial Call Center | Albany, New York, United States, 12206 |
| Novo Nordisk Clinical Trial Call Center | Northport, New York, United States, 11768 |
| Novo Nordisk Clinical Trial Call Center | Asheville, North Carolina, United States, 28801 |
| Novo Nordisk Clinical Trial Call Center | Chapel Hill, North Carolina, United States, 27599-7172 |
| Novo Nordisk Clinical Trial Call Center | Durham, North Carolina, United States, 27710 |
| Novo Nordisk Clinical Trial Call Center | Greenville, North Carolina, United States, 27834 |
| Novo Nordisk Clinical Trial Call Center | Cincinnati, Ohio, United States, 45245 |
| Novo Nordisk Clinical Trial Call Center | Cleveland, Ohio, United States, 44195 |
| Novo Nordisk Clinical Trial Call Center | Columbus, Ohio, United States, 43212 |
| Novo Nordisk Clinical Trial Call Center | Columbus, Ohio, United States, 43203 |
| Novo Nordisk Clinical Trial Call Center | Dayton, Ohio, United States, 45406 |
| Novo Nordisk Clinical Trial Call Center | Kettering, Ohio, United States, 45429 |
| Novo Nordisk Clinical Trial Call Center | Mentor, Ohio, United States, 44060 |
| Novo Nordisk Clinical Trial Call Center | Duncan, South Carolina, United States, 29334 |
| Novo Nordisk Clinical Trial Call Center | Chattanooga, Tennessee, United States, 37404 |
| Novo Nordisk Clinical Trial Call Center | Arlington, Texas, United States, 76014 |
| Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75390-8858 |
| Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75230 |
| Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75246 |
| Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75231 |
| Novo Nordisk Clinical Trial Call Center | Houston, Texas, United States, 77030 |
| Novo Nordisk Clinical Trial Call Center | Houston, Texas, United States, 77025 |
| Novo Nordisk Clinical Trial Call Center | Midland, Texas, United States, 79707 |
| Novo Nordisk Clinical Trial Call Center | San Antonio, Texas, United States, 78229 |
| Novo Nordisk Clinical Trial Call Center | San Antonio, Texas, United States, 78209 |
| Novo Nordisk Clinical Trial Call Center | Salt Lake City, Utah, United States, 84102 |
| Novo Nordisk Clinical Trial Call Center | Norfolk, Virginia, United States, 23502 |
| Novo Nordisk Clinical Trial Call Center | Richmond, Virginia, United States, 23294 |
| Novo Nordisk Clinical Trial Call Center | Spokane, Washington, United States, 99207 |
| Novo Nordisk Clinical Trial Call Center | Milwaukee, Wisconsin, United States, 53209 |
| Canada, Alberta | Calgary, Alberta, Canada, T2H 2G4 |
| Canada, Alberta | Edmonton, Alberta, Canada, T5J 3N4 |
| Canada, Manitoba | Winnipeg, Manitoba, Canada, R3E 3P4 |
| Canada, Nova Scotia | Halifax, Nova Scotia, Canada, B3H 1V7 |
| Canada, Ontario | London, Ontario, Canada, N6A 4V2 |
| Canada, Ontario | Ottawa, Ontario, Canada, K1N 6N5 |
| Canada, Ontario | Toronto, Ontario, Canada, M5C 2T2 |
| Canada, Quebec | Laval, Quebec, Canada, H7T 2P5 |
| Canada | Gatineau, Canada, J8T 8M1 |
| Canada | Mississauga, Canada, L5M 2V8 |
| Canada | Montreal, Canada, H2W 1R7 |
| Canada | Montreal, Canada, H3A 1A1 |
| Canada | Red Deer, Canada, T4N 6V7 |
| Canada | St John's, Canada, A1B 3V6 |
| Canada | Toronto, Canada, M5G 1X5 |
| Canada | Vancouver, Canada, V5Z 1C6 |
| Canada | Windsor, Canada, N8W 3K2 |