The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT00700817
Last Updated: 2017-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
665 participants
INTERVENTIONAL
2008-06-30
2010-06-30
Brief Summary
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The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:
1. Week 27-52 after randomisation
\- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
2. Week 53-78 after randomisation
* Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
* Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.
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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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Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
liraglutide
1.2 mg once daily, subcutaneous (under the skin) injection
metformin
Tablets, minimum 1500 mg daily
Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).
metformin
Tablets, minimum 1500 mg daily
liraglutide
1.8 mg once daily, subcutaneous (under the skin) injection
Sita -> Sita
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
sitagliptin
Tablets, 100 mg daily
metformin
Tablets, minimum 1500 mg daily
Sita -> Sita -> Lira 1.2 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
liraglutide
1.2 mg once daily, subcutaneous (under the skin) injection
sitagliptin
Tablets, 100 mg daily
metformin
Tablets, minimum 1500 mg daily
Sita -> Sita -> Lira 1.8 mg
Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
sitagliptin
Tablets, 100 mg daily
metformin
Tablets, minimum 1500 mg daily
liraglutide
1.8 mg once daily, subcutaneous (under the skin) injection
Interventions
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liraglutide
1.2 mg once daily, subcutaneous (under the skin) injection
sitagliptin
Tablets, 100 mg daily
metformin
Tablets, minimum 1500 mg daily
liraglutide
1.8 mg once daily, subcutaneous (under the skin) injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 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
Birmingham, Alabama, United States
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Escondido, California, United States
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Fresno, California, United States
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Huntington Beach, California, United States
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Long Beach, California, United States
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Northridge, California, United States
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Orange, California, United States
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Poway, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Crystal River, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Panama City, Florida, United States
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Saint Cloud, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Dunwoody, Georgia, United States
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Lithia Springs, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Shawnee Mission, Kansas, United States
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Metairie, Louisiana, United States
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Hyattsville, Maryland, United States
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Minneapolis, Minnesota, United States
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Cleveland, Mississippi, United States
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City of Saint Peters, Missouri, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Northport, New York, United States
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Rosedale, New York, United States
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Pinehurst, North Carolina, United States
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Tabor City, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Cuyahoga Falls, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Mentor, Ohio, United States
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Eugene, Oregon, United States
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Altoona, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Kingsport, Tennessee, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Hurst, Texas, United States
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New Braunfels, 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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Ogden, Utah, United States
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St. George, Utah, United States
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South Burlington, Vermont, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Milwaukee, Wisconsin, United States
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Hamilton, , Canada
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Karlovac, , Croatia
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Sisak, , Croatia
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Slavonski Brod, , Croatia
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La Roche-sur-Yon, , France
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La Rochelle, , France
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Limoges, , France
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Narbonne, , France
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Rennes, , France
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Saint-Mandé, , France
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Strasbourg, , France
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Vénissieux, , France
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Bad Lauterberg im Harz, , Germany
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Bochum, , Germany
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Dormagen, , Germany
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Frankfurt, , Germany
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Herrenberg, , Germany
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Kassel, , Germany
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Marburg, , Germany
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Riesa, , Germany
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Schönebeck, , Germany
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Ulm, , Germany
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Völklingen, , Germany
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Wangen, , Germany
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Catania, , Italy
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Lucca, , Italy
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Messina, , Italy
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Olbia, , Italy
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Palermo, , Italy
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Pavia, , Italy
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Roma, , Italy
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Siena, , Italy
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Trieste, , Italy
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Almere Stad, , Netherlands
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Apeldoorn, , Netherlands
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Beek, , Netherlands
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Groningen, , Netherlands
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Hengelo, , Netherlands
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Leiden, , Netherlands
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Roelofarendsveen, , Netherlands
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Stadskanaal, , Netherlands
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Zevenaar, , Netherlands
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Zoetermeer, , Netherlands
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Caquas, , Puerto Rico
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Guaynabo, , Puerto Rico
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Manatí, , Puerto Rico
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Rio Piedras, , Puerto Rico
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Trujillo Alto, , Puerto Rico
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Oradea, Bihor County, Romania
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Craiova, Dolj, Romania
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Bucharest, , Romania
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Timișoara, , Romania
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Belgrade, , Serbia and Montenegro
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Nis, , Serbia and Montenegro
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Nitra, , Slovakia
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Nové Zámky, , Slovakia
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Ljubljana, , Slovenia
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Novo Mesto, , Slovenia
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Trbovlje, , Slovenia
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Alzira, , Spain
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Barcelona, , Spain
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Getafe, , Spain
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L'Hospitalet de Llobregat, , Spain
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Málaga, , Spain
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Oviedo, , Spain
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Palma de Mallorca, , Spain
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Palma de Mallorca, , Spain
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Puerto del Rosario, , Spain
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Aberdeen, , United Kingdom
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Abergavenny, , United Kingdom
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Aldershot, , United Kingdom
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Ayr, , United Kingdom
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Birmingham, , United Kingdom
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Chippenham, , United Kingdom
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Coventry, , United Kingdom
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Edgbaston, Birmingham, , United Kingdom
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Edinburgh, , United Kingdom
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Edinburgh, , United Kingdom
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Glasgow, , United Kingdom
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Leicester, , United Kingdom
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Letchworth Garden City, , United Kingdom
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Liverpool, , United Kingdom
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Maidstone, , United Kingdom
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Nottingham, , United Kingdom
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Oxford, , United Kingdom
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Salford, , United Kingdom
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Sheffield, , United Kingdom
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Swansea, , United Kingdom
Countries
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References
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Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Thomsen AB, Sondergaard RE, Davies M; 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010 Apr 24;375(9724):1447-56. doi: 10.1016/S0140-6736(10)60307-8.
Davies M, Pratley R, Hammer M, Thomsen AB, Cuddihy R. Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin. Diabet Med. 2011 Mar;28(3):333-7. doi: 10.1111/j.1464-5491.2010.03074.x.
Pratley R, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Garber A, Thomsen AB, Hartvig H, Davies M; 1860-LIRA-DPP-4 Study Group. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011 Apr;65(4):397-407. doi: 10.1111/j.1742-1241.2011.02656.x. Epub 2011 Mar 1.
Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.
Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.
Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x.
Pratley RE, Nauck MA, Bailey T, Montanya E, Filetti S, Garber AJ, Thomsen AB, Furber S, Davies M; 1860-LIRA-DPP-4 Study Group. Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial. Diabetes Care. 2012 Oct;35(10):1986-93. doi: 10.2337/dc11-2113. Epub 2012 Jul 30.
Lee WC, Samyshkin Y, Langer J, Palmer JL. Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis. J Med Econ. 2012;15 Suppl 2:28-37. doi: 10.3111/13696998.2012.716111. Epub 2012 Aug 13.
Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.
Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.
Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.
Langer J, Hunt B, Valentine WJ. Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States. J Manag Care Pharm. 2013 Apr;19(3):237-46. doi: 10.18553/jmcp.2013.19.3.237.
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Clinical Trials at Novo Nordisk
Other Identifiers
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2007-003937-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN2211-1860
Identifier Type: -
Identifier Source: org_study_id
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