Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
NCT ID: NCT00982644
Last Updated: 2017-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1030 participants
INTERVENTIONAL
2009-09-30
2010-12-31
Brief Summary
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All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.
The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IDeg OD
insulin degludec
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
IGlar OD
insulin glargine
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Interventions
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insulin degludec
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
insulin glargine
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
Eligibility Criteria
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Inclusion Criteria
* Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose
* HbA1c: 7.0-10.0%
* Body Mass Index (BMI) no higher than 40.0 kg/m\^2
* For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)
Exclusion Criteria
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
* Cancer and medical history of cancer
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Bay Minette, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Goodyear, Arizona, United States
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Anaheim, California, United States
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Concord, California, United States
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La Jolla, California, United States
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Lancaster, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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National City, California, United States
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North Hollywood, California, United States
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Northridge, California, United States
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Palm Springs, California, United States
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San Mateo, California, United States
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Santa Monica, California, United States
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Spring Valley, California, United States
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Tarzana, California, United States
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Tustin, California, United States
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Norwalk, Connecticut, United States
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Boynton Beach, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Orange Park, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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West Palm Beach, Florida, United States
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Decatur, Georgia, United States
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Fort Valley, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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Paducah, Kentucky, United States
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Metairie, Louisiana, United States
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Slidell, Louisiana, United States
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Greenbelt, Maryland, United States
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North East, Maryland, United States
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Reisterstown, Maryland, United States
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Rockville, Maryland, United States
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Brockton, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Toms River, New Jersey, United States
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Northport, New York, United States
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Staten Island, New York, United States
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Asheboro, North Carolina, United States
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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Kingston, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Melrose Park, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Columbia, South Carolina, United States
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Greer, South Carolina, United States
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Newberry, South Carolina, United States
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Chattanooga, Tennessee, United States
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Harriman, Tennessee, United States
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Humboldt, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Hurst, Texas, United States
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Irving, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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Bregenz, , Austria
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Feldkirch, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Wolfsberg, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Edmonton, Alberta, Canada
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Coquitlam, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Ottawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Saint Romuald, Quebec, Canada
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Saint-Marc-des-Carrieres, Quebec, Canada
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Brno, , Czechia
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Hradec Králové, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Esbjerg, , Denmark
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Hillerød, , Denmark
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Holbæk, , Denmark
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København S, , Denmark
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Odense, , Denmark
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Silkeborg, , Denmark
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Helsinki, , Finland
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Joensuu, , Finland
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Kerava, , Finland
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Lohja, , Finland
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Oulu, , Finland
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Tampere, , Finland
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Le Grau-du-Roi, , France
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Montigny-lès-Metz, , France
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Nanterre, , France
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Nantes, , France
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Nîmes, , France
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Saint-denis de La Reunion, , France
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Vénissieux, , France
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Bad Harzburg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Dormagen, , Germany
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Dresden, , Germany
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Essen, , Germany
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Friedrichsthal, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hohenmölsen, , Germany
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Neuwied, , Germany
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Pohlheim, , Germany
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Rehburg-Loccum, , Germany
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Rehlingen-Siersburg, , Germany
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Riesa, , Germany
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Saint Ingbert, , Germany
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Speyer, , Germany
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Ålesund, , Norway
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Bekkestua, , Norway
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Elverum, , Norway
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Hamar, , Norway
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Kongsvinger, , Norway
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Oslo, , Norway
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Stavanger, , Norway
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Trondheim, , Norway
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Bayamón, , Puerto Rico
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Belgrade, , Serbia and Montenegro
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Kragujevac, , Serbia and Montenegro
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Nis, , Serbia and Montenegro
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Novi Sad, , Serbia and Montenegro
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Belgrade, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Novi Sad, , Serbia
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Koper, , Slovenia
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Ljubljana, , Slovenia
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Novo Mesto, , Slovenia
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Almería, , Spain
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Alzira, , Spain
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Antequera, , Spain
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Ferrol, , Spain
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Gijón, , Spain
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Inca, , Spain
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Palma de Mallorca, , Spain
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Puerto del Rosario, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
Countries
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References
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Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.
Sorli C, Warren M, Oyer D, Mersebach H, Johansen T, Gough SC. Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials. Drugs Aging. 2013 Dec;30(12):1009-18. doi: 10.1007/s40266-013-0128-2.
Einhorn D, Handelsman Y, Bode BW, Endahl LA, Mersebach H, King AB. PATIENTS ACHIEVING GOOD GLYCEMIC CONTROL (HBA1c <7%) EXPERIENCE A LOWER RATE OF HYPOGLYCEMIA WITH INSULIN DEGLUDEC THAN WITH INSULIN GLARGINE: A META-ANALYSIS OF PHASE 3A TRIALS. Endocr Pract. 2015 Aug;21(8):917-26. doi: 10.4158/EP14523.OR. Epub 2015 Jun 29.
Russell-Jones D, Gall MA, Niemeyer M, Diamant M, Del Prato S. Insulin degludec results in lower rates of nocturnal hypoglycaemia and fasting plasma glucose vs. insulin glargine: A meta-analysis of seven clinical trials. Nutr Metab Cardiovasc Dis. 2015 Oct;25(10):898-905. doi: 10.1016/j.numecd.2015.06.005. Epub 2015 Jun 18.
Vora J, Seufert J, Solberg H, Kinduryte O, Johansen T, Hollander P. Insulin degludec does not increase antibody formation versus insulin glargine: an evaluation of phase IIIa trials. Diabetes Obes Metab. 2016 Jul;18(7):716-20. doi: 10.1111/dom.12621. Epub 2016 Feb 8.
Rodbard HW, Cariou B, Zinman B, Handelsman Y, Philis-Tsimikas A, Skjoth TV, Rana A, Mathieu C; BEGIN Once Long trial investigators. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial. Diabet Med. 2013 Nov;30(11):1298-304. doi: 10.1111/dme.12303. Epub 2013 Sep 30.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-005776-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1111-8692
Identifier Type: OTHER
Identifier Source: secondary_id
2009-015754-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1114-9426
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-3579
Identifier Type: -
Identifier Source: org_study_id
NCT01193309
Identifier Type: -
Identifier Source: nct_alias
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