The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension
18 Years
80 Years
Both
Diabetes, Diabetes Mellitus, Type 2
Trial Information
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension
Inclusion Criteria:
- Type 2 diabetes
- Treatment with metformin alone for at least three months
- HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
- Body Mass Index (BMI) less than or equal to 45.0
Exclusion Criteria:
- Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or
dipeptidyl peptidase-4 (DPP-4) inhibitors
- Treatment with anti-diabetic drugs other than metformin within the last three months
- Any serious medical condition
- Females who are pregnant, have the intention of becoming pregnant or are
breastfeeding
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Outcome Description:
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Outcome Time Frame:
Week 0, Week 26
Safety Issue:
No
Principal Investigator
Anne Bloch Thomsen
Investigator Role:
Study Director
Investigator Affiliation:
Novo Nordisk
Authority:
United States: Food and Drug Administration
Study ID:
NN2211-1860
NCT ID:
NCT00700817
Start Date:
June 2008
Completion Date:
June 2010
Related Keywords:
- Diabetes
- Diabetes Mellitus, Type 2
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
Name | Location |
|---|---|
| Novo Nordisk Clinical Trial Call Center | Birmingham, Alabama 35242 |
| Novo Nordisk Clinical Trial Call Center | Escondido, California 92026 |
| Novo Nordisk Clinical Trial Call Center | Jacksonville, Florida 32216 |
| Novo Nordisk Clinical Trial Call Center | Athens, Georgia 30606 |
| Novo Nordisk Clinical Trial Call Center | Honolulu, Hawaii 96814 |
| Novo Nordisk Clinical Trial Call Center | Boise, Idaho 83702 |
| Novo Nordisk Clinical Trial Call Center | Chicago, Illinois 60616 |
| Novo Nordisk Clinical Trial Call Center | Shawnee Mission, Kansas 66204 |
| Novo Nordisk Clinical Trial Call Center | Metairie, Louisiana 70002 |
| Novo Nordisk Clinical Trial Call Center | Hyattsville, Maryland 20782 |
| Novo Nordisk Clinical Trial Call Center | Minneapolis, Minnesota 55416-2699 |
| Novo Nordisk Clinical Trial Call Center | Cleveland, Mississippi 38732 |
| Novo Nordisk Clinical Trial Call Center | St. Peters, Missouri 63376 |
| Novo Nordisk Clinical Trial Call Center | Las Vegas, Nevada 89109 |
| Novo Nordisk Clinical Trial Call Center | Berlin, New Jersey 08009 |
| Novo Nordisk Clinical Trial Call Center | Northport, New York 11768 |
| Novo Nordisk Clinical Trial Call Center | Pinehurst, North Carolina 28374 |
| Novo Nordisk Clinical Trial Call Center | Cincinnati, Ohio 45245 |
| Novo Nordisk Clinical Trial Call Center | Eugene, Oregon 97404 |
| Novo Nordisk Clinical Trial Call Center | Norristown, Pennsylvania 19401 |
| Novo Nordisk Clinical Trial Call Center | Kingsport, Tennessee 37660 |
| Novo Nordisk Clinical Trial Call Center | Arlington, Texas 76014 |
| Novo Nordisk Clinical Trial Call Center | Ogden, Utah 84403 |
| Novo Nordisk Clinical Trial Call Center | South Burlington, Vermont 05403 |
| Novo Nordisk Clinical Trial Call Center | Norfolk, Virginia 23502 |
| Novo Nordisk Clinical Trial Call Center | Milwaukee, Wisconsin 53209 |
