The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
January 25, 2017 updated by: Novo Nordisk A/S
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
This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.
The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:
Week 27-52 after randomisation
- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
665
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hamilton, Canada, L8M 1K7
- Novo Nordisk Investigational Site
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Alberta
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Edmonton, Alberta, Canada, T5A 4L8
- Novo Nordisk Investigational Site
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Novo Nordisk Investigational Site
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Ontario
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London, Ontario, Canada, N6G 2M1
- Novo Nordisk Investigational Site
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Newmarket, Ontario, Canada, L4Y 8E3
- Novo Nordisk Investigational Site
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Ottawa, Ontario, Canada, K1N 6N5
- Novo Nordisk Investigational Site
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Toronto, Ontario, Canada, M3J 1N2
- Novo Nordisk Investigational Site
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Toronto, Ontario, Canada, M5C 2T2
- Novo Nordisk Investigational Site
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Toronto, Ontario, Canada, M5T 3L9
- Novo Nordisk Investigational Site
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Quebec
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Montreal, Quebec, Canada, H2W 1T8
- Novo Nordisk Investigational Site
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Montreal, Quebec, Canada, H3J 2V5
- Novo Nordisk Investigational Site
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Karlovac, Croatia, 47000
- Novo Nordisk Investigational Site
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Sisak, Croatia, 44000
- Novo Nordisk Investigational Site
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Slavonski Brod, Croatia, 35 000
- Novo Nordisk Investigational Site
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Belgrade, Former Serbia and Montenegro, 11000
- Novo Nordisk Investigational Site
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Nis, Former Serbia and Montenegro, 18000
- Novo Nordisk Investigational Site
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LA ROCHE-sur-YON cedex 9, France, 85295
- Novo Nordisk Investigational Site
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LA ROCHELLE cedex, France, 17019
- Novo Nordisk Investigational Site
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Limoges, France, 87042
- Novo Nordisk Investigational Site
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Narbonne, France, 11108
- Novo Nordisk Investigational Site
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Rennes, France, 35056
- Novo Nordisk Investigational Site
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Saint Mandé, France, 94160
- Novo Nordisk Investigational Site
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Strasbourg, France, 67000
- Novo Nordisk Investigational Site
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Venissieux, France, 69200
- Novo Nordisk Investigational Site
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Bad Lauterberg, Germany, 37431
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Bochum, Germany, 44791
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Dormagen, Germany, 41539
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Frankfurt, Germany, 60388
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Herrenberg, Germany, 71083
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Kassel, Germany, 34117
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Marburg, Germany, 35039
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Riesa, Germany, 01587
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Schönebeck, Germany, 39218
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Ulm, Germany, 89073
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Völklingen, Germany, 66333
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Wangen, Germany, 88239
- Novo Nordisk Investigational Site
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Dublin, Ireland, DUBLIN 15
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Dublin, Ireland, DUBLIN 4
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Dublin, Ireland, DUBLIN 7
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Dublin, Ireland, DUBLIN 8
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Dublin 9, Ireland
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Catania, Italy, 95124
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Lucca, Italy, 55100
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Messina, Italy, 98123
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Olbia, Italy, 07026
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Palermo, Italy, 90123
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Pavia, Italy, 27100
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Roma, Italy, 00161
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Siena, Italy, 53100
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Trieste, Italy, 34148
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Almere, Netherlands, 1311RL
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Apeldoorn, Netherlands, 7334 DZ
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Beek, Netherlands, 6191JW
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Groningen, Netherlands, 9728 NT
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Hengelo, Netherlands, 7555 DL
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Leiden, Netherlands, 2333 ZA
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Roelofarendsveen, Netherlands, 2371 RB
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Stadskanaal, Netherlands, 9501 EH
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Zevenaar, Netherlands, 6903 ZN
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Zoetermeer, Netherlands, 2725 NA
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Caquas, Puerto Rico, 00725
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Guaynabo, Puerto Rico, 00968
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Manati, Puerto Rico, 00674
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Rio Piedras, Puerto Rico, 00921
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Trujillo Alto, Puerto Rico, 00976
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Bucharest, Romania, 020614
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Timisoara, Romania, 300736
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Bihor
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Oradea, Bihor, Romania, 410469
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Dolj
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Craiova, Dolj, Romania, 200642
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Bratislava, Slovakia, 811 08
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Bratislava, Slovakia, 82102
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Bratislava, Slovakia, 851 05
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Nitra, Slovakia, 94 911
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Nove Zamky, Slovakia, 940 59
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Ljubljana, Slovenia, 1525
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Novo mesto, Slovenia, 8000
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Trbovlje, Slovenia, 1420
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Alzira, Spain, 46600
- Novo Nordisk Investigational Site
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Barcelona, Spain, 08036
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Getafe, Spain, 28905
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Hospitalet de Llobregat, Spain, 08907
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Málaga, Spain, 29010
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Oviedo, Spain, 33006
- Novo Nordisk Investigational Site
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Palma de Mallorca, Spain, 07010
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Palma de Mallorca, Spain, 07014
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Puerto del Rosario, Spain, 35600
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Aberdeen, United Kingdom, AB25 1LD
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Abergavenny, United Kingdom, NP7 7EG
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Aldershot, United Kingdom, GU12 5BA
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Ayr, United Kingdom, KA6 6DX
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Birmingham, United Kingdom, B9 5SS
- Novo Nordisk Investigational Site
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Chippenham, United Kingdom, SN15 2SB
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Coventry, United Kingdom, CV6 2FL
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Edgbaston, Birmingham, United Kingdom, B15 2TH
- Novo Nordisk Investigational Site
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Edinburgh, United Kingdom, EH4 2XU
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Edinburgh, United Kingdom, EH16 4SA
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Glasgow, United Kingdom, G45 9AW
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Leicester, United Kingdom, LE1 5WW
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Letchworth, United Kingdom, SG6 4UB
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Liverpool, United Kingdom, L9 7AL
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Maidstone, United Kingdom, ME16 9QQ
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Nottingham, United Kingdom, NG7 2UH
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Oxford, United Kingdom, OX3 7LE
- Novo Nordisk Investigational Site
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Salford, United Kingdom, M6 8HD
- Novo Nordisk Investigational Site
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Sheffield, United Kingdom, S5 7AU
- Novo Nordisk Investigational Site
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Swansea, United Kingdom, SA6 6NL
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Alabama
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Birmingham, Alabama, United States, 35242
- Novo Nordisk Investigational Site
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California
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Escondido, California, United States, 92025
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Fresno, California, United States, 93720
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Huntington Beach, California, United States, 92646
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Long Beach, California, United States, 90822
- Novo Nordisk Investigational Site
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Northridge, California, United States, 91325
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Orange, California, United States, 92869
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Poway, California, United States, 92064
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Walnut Creek, California, United States, 94598
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Colorado
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Denver, Colorado, United States, 80209
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Florida
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Crystal River, Florida, United States, 34429
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Jacksonville, Florida, United States, 32216
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Jacksonville, Florida, United States, 32205
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Miami, Florida, United States, 33169
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Ocala, Florida, United States, 34471
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Panama City, Florida, United States, 32401
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St. Cloud, Florida, United States, 34769
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Georgia
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Athens, Georgia, United States, 30606
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Atlanta, Georgia, United States, 30342
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Dunwoody, Georgia, United States, 30338
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Lithia Springs, Georgia, United States, 30122
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Hawaii
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Honolulu, Hawaii, United States, 96814
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Idaho
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Boise, Idaho, United States, 83702
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Illinois
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Chicago, Illinois, United States, 60616
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Kansas
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Shawnee Mission, Kansas, United States, 66204
- Novo Nordisk Investigational Site
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Louisiana
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Metairie, Louisiana, United States, 70002
- Novo Nordisk Investigational Site
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Maryland
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Hyattsville, Maryland, United States, 20782
- Novo Nordisk Investigational Site
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Minnesota
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Minneapolis, Minnesota, United States, 55416
- Novo Nordisk Investigational Site
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Mississippi
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Cleveland, Mississippi, United States, 38732
- Novo Nordisk Investigational Site
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Missouri
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St. Peters, Missouri, United States, 63376
- Novo Nordisk Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89109
- Novo Nordisk Investigational Site
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New Jersey
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Berlin, New Jersey, United States, 08009
- Novo Nordisk Investigational Site
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New York
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Northport, New York, United States, 11768
- Novo Nordisk Investigational Site
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Rosedale, New York, United States, 11422
- Novo Nordisk Investigational Site
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North Carolina
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Pinehurst, North Carolina, United States, 28374
- Novo Nordisk Investigational Site
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Tabor City, North Carolina, United States, 28463
- Novo Nordisk Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45245
- Novo Nordisk Investigational Site
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Columbus, Ohio, United States, 43201
- Novo Nordisk Investigational Site
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Cuyahoga Falls, Ohio, United States, 44223
- Novo Nordisk Investigational Site
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Dayton, Ohio, United States, 45439
- Novo Nordisk Investigational Site
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Dayton, Ohio, United States, 45406
- Novo Nordisk Investigational Site
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Mentor, Ohio, United States, 44060
- Novo Nordisk Investigational Site
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Oregon
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Eugene, Oregon, United States, 97404
- Novo Nordisk Investigational Site
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- Novo Nordisk Investigational Site
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Norristown, Pennsylvania, United States, 19401
- Novo Nordisk Investigational Site
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Tennessee
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Kingsport, Tennessee, United States, 37660
- Novo Nordisk Investigational Site
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Texas
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Arlington, Texas, United States, 76014
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75230
- Novo Nordisk Investigational Site
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Houston, Texas, United States, 77024
- Novo Nordisk Investigational Site
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Houston, Texas, United States, 77030
- Novo Nordisk Investigational Site
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Hurst, Texas, United States, 76054
- Novo Nordisk Investigational Site
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New Braunfels, Texas, United States, 78130
- Novo Nordisk Investigational Site
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San Antonio, Texas, United States, 78229
- Novo Nordisk Investigational Site
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Sugar Land, Texas, United States, 77479
- Novo Nordisk Investigational Site
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Utah
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Ogden, Utah, United States, 84403
- Novo Nordisk Investigational Site
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St. George, Utah, United States, 84790
- Novo Nordisk Investigational Site
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Vermont
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South Burlington, Vermont, United States, 05403
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Virginia
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Newport News, Virginia, United States, 23606
- Novo Nordisk Investigational Site
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Richmond, Virginia, United States, 23294
- Novo Nordisk Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53209
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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).
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1.2 mg once daily, subcutaneous (under the skin) injection
Tablets, minimum 1500 mg daily
1.8 mg once daily, subcutaneous (under the skin) injection
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Experimental: 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).
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1.2 mg once daily, subcutaneous (under the skin) injection
Tablets, minimum 1500 mg daily
1.8 mg once daily, subcutaneous (under the skin) injection
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Active Comparator: 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).
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Tablets, minimum 1500 mg daily
Tablets, 100 mg daily
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Experimental: 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.
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1.2 mg once daily, subcutaneous (under the skin) injection
Tablets, minimum 1500 mg daily
1.8 mg once daily, subcutaneous (under the skin) injection
Tablets, 100 mg daily
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Experimental: 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.
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1.2 mg once daily, subcutaneous (under the skin) injection
Tablets, minimum 1500 mg daily
1.8 mg once daily, subcutaneous (under the skin) injection
Tablets, 100 mg daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Time Frame: Week 0, Week 26
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Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
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Week 0, Week 26
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Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Time Frame: Week 0, Week 52
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Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
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Week 0, Week 52
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Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
Time Frame: Week 0, Week 78
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Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
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Week 0, Week 78
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Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
Time Frame: Week 52, Week 78
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Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78
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Week 52, Week 78
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
Time Frame: Week 0, Week 26
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Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26
|
Week 0, Week 26
|
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Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52
|
Week 0, Week 52
|
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Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Time Frame: Week 0, Week 78
|
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78.
Based on the FAS.
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Week 0, Week 78
|
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Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Time Frame: Week 0, Week 78
|
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78.
Based on the extension 2 FAS.
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Week 0, Week 78
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Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
Time Frame: Week 0, Week 26
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Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26
|
Week 0, Week 26
|
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Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52
|
Week 0, Week 52
|
|
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Time Frame: Week 0, Week 78
|
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78.
Based on the FAS.
|
Week 0, Week 78
|
|
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Time Frame: Week 0, Week 78
|
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78.
Based on the extension 2 FAS.
|
Week 0, Week 78
|
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Mean Change From Baseline in Body Weight at Week 26
Time Frame: Week 0, Week 26
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Calculated as an estimate of the mean change from baseline in body weight at Week 26.
|
Week 0, Week 26
|
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Mean Change From Baseline in Body Weight at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change from baseline in body weight at Week 52.
|
Week 0, Week 52
|
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Mean Change in Body Weight From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in body weight from Week 52 to Week 78.
|
Week 52, Week 78
|
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Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.
|
Week 0, Week 26
|
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Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.
|
Week 0, Week 52
|
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Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
Time Frame: Week 0, Week 78
|
Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.
|
Week 0, Week 78
|
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Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Beta-cell Function at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). |
Week 0, Week 26
|
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Mean Change From Baseline in Beta-cell Function at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). |
Week 0, Week 52
|
|
Mean Change in Beta-cell Function From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in beta-cell function from Week 52 to Week 78.
Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
|
Week 52, Week 78
|
|
Mean Change From Baseline in Total Cholesterol at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Total Cholesterol at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.
|
Week 0, Week 52
|
|
Mean Change in Total Cholesterol From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in total cholesterol from Week 52 to Week 78
|
Week 52, Week 78
|
|
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.
|
Week 0, Week 52
|
|
Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.
|
Week 0, Week 52
|
|
Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.
|
Week 0, Week 52
|
|
Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Triglycerides (TG) at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Triglycerides (TG) at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.
|
Week 0, Week 52
|
|
Mean Change in Triglycerides (TG) From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in triglycerides (TG) from Week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.
|
Week 0, Week 52
|
|
Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in free fatty acids (FFA) from Week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Apolipoprotein B at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Apolipoprotein B at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.
|
Week 0, Week 52
|
|
Mean Change in Apolipoprotein B From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Adiponectin at Week 26.
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26.
vWf is a blood glycoprotein involved in haemostasis.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Waist to Hip Ratio at Week 26.
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26.
The measure is assessed as the circumference of the waist divided by the circumference of the hip.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Waist to Hip Ratio at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52.
The measure is assessed as the circumference of the waist divided by the circumference of the hip.
|
Week 0, Week 52
|
|
Mean Change in Waist to Hip Ratio From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in Waist to Hip Ratio from Week 52 to Week 78.
The measure is assessed as the circumference of the waist divided by the circumference of the hip.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Waist Circumference at Week 26.
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26
|
Week 0, Week 26
|
|
Mean Change From Baseline in Waist Circumference at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.
|
Week 0, Week 52
|
|
Mean Change in Waist Circumference From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in Waist Circumference from Week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26
|
Week 0, Week 26
|
|
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.
|
Week 0, Week 52
|
|
Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.
|
Week 0, Week 52
|
|
Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Pulse at Week 26
Time Frame: Week 0, Week 26
|
Calculated as an estimate of the mean change from baseline in pulse at Week 26.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Pulse at Week 52
Time Frame: Week 0, Week 52
|
Calculated as an estimate of the mean change from baseline in pulse at Week 52.
|
Week 0, Week 52
|
|
Mean Change in Pulse From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
Mean change in pulse from Week 52 to Week 78.
|
Week 52, Week 78
|
|
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26
Time Frame: Week 0, Week 26
|
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction.
The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
|
Week 0, Week 26
|
|
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52
Time Frame: Week 0, Week 52
|
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction.
The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
|
Week 0, Week 52
|
|
Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78
Time Frame: Week 52, Week 78
|
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction.
The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
|
Week 52, Week 78
|
|
Hypoglyceamic Episodes, Weeks 0-26
Time Frame: Weeks 0-26
|
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only.
Major if unable to treat her/himself.
Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
|
Weeks 0-26
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Time Frame: Weeks 0-26
|
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only.
Major if unable to treat her/himself.
Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
|
Weeks 0-26
|
|
Hypoglyceamic Episodes, Weeks 0-52
Time Frame: Weeks 0-52
|
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only.
Major if unable to treat her/himself.
Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
|
Weeks 0-52
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
Time Frame: Weeks 0-52
|
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only.
Major if unable to treat her/himself.
Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
|
Weeks 0-52
|
|
Hypoglyceamic Episodes, Weeks 0-78
Time Frame: Weeks 0-78
|
Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only.
Major if unable to treat her/himself.
Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
|
Weeks 0-78
|
|
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
Time Frame: Weeks 0-78
|
Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only.
Major if unable to treat her/himself.
Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
|
Weeks 0-78
|
|
Hypoglycaamic Episodes, Weeks 52-78
Time Frame: Week 52-78
|
Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only.
Major if unable to treat her/himself.
Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
|
Week 52-78
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Lancet. 2010 Jul 24;376(9737):234.
- 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. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
June 18, 2008
First Submitted That Met QC Criteria
June 18, 2008
First Posted (Estimate)
June 19, 2008
Study Record Updates
Last Update Posted (Actual)
March 8, 2017
Last Update Submitted That Met QC Criteria
January 25, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Liraglutide
- Metformin
- Sitagliptin Phosphate
Other Study ID Numbers
- NN2211-1860
- 2007-003937-17 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.