- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01541215
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes (Ellipse™)
Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Queensland
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Ipswich, Queensland, Australia, 4305
- Novo Nordisk INvestigational Site
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
- Novo Nordisk INvestigational Site
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Salzburg, Austria, 5020
- Novo Nordisk INvestigational Site
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Wels, Austria, 4600
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Brussel, Belgium, 1090
- Novo Nordisk INvestigational Site
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Bruxelles, Belgium, 1200
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Leuven, Belgium, 3000
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 91350-250
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Alberta
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Edmonton, Alberta, Canada, T5X 3N5
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
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Ontario
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Brampton, Ontario, Canada, L6T 0G1
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Quebec
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Westmount, Quebec, Canada, H3Z 1E5
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Rijeka, Croatia, 51000
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Zagreb, Croatia, 10 000
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Herlev, Denmark, 2730
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Næstved, Denmark, 4700
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Alexandria, Egypt, 21131
- Novo Nordisk INvestigational Site
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Cairo, Egypt, 11562
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Cairo, Egypt, 11628
- Novo Nordisk INvestigational Site
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Mansoura, Egypt, 35516
- Novo Nordisk INvestigational Site
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MONTPELLIER cedex 05, France, 34295
- Novo Nordisk INvestigational Site
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Marseille, France, 13006
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Ludwigshafen, Germany, 67059
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Mayen, Germany, 56727
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Athens, Greece, GR-17562
- Novo Nordisk INvestigational Site
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Athens, Greece, 151 23
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Goudi/ Athens, Greece, GR-11527
- Novo Nordisk INvestigational Site
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Thessaloniki, Greece, GR-54643
- Novo Nordisk INvestigational Site
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Budapest, Hungary, 1089
- Novo Nordisk INvestigational Site
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Budapest, Hungary, 1023
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Budapest, Hungary, 1094
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Miskolc, Hungary, 3501
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Szombathely, Hungary, H-9700
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Kolkata, India, 700017
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Andhra Pradesh
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Guntur, Andhra Pradesh, India, 522001
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Hyderabad, Andhra Pradesh, India, 500072
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Karnataka
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Bangalore, Karnataka, India, 560054
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Bangalore, Karnataka, India, 560 017
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Bangalore, Karnataka, India, 560041
- Novo Nordisk INvestigational Site
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Bangalore, Karnataka, India, 560052
- Novo Nordisk INvestigational Site
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Maharashtra
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Mumbai, Maharashtra, India, 400008
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Mumbai, Maharashtra, India, 400703
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Pune, Maharashtra, India, 411001
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New Delhi
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New Dehli, New Delhi, India, 110029
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Punjab
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Chandigarh, Punjab, India, 160012
- Novo Nordisk INvestigational Site
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Ludhiana, Punjab, India, 141001
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Rajasthan
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Jaipur, Rajasthan, India, 302006
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600086
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Telengana
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Hyderbad, Telengana, India, 500 012
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West Bengal
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Kolkata, West Bengal, India, 700020
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Beer Sheva, Israel, 84101
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Haifa, Israel, 31096
- Novo Nordisk INvestigational Site
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Jerusalem, Israel, 91240
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Petah Tikva, Israel, 49202
- Novo Nordisk INvestigational Site
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Tel Hashomer, Israel, 52621
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Roma, Italy, 00165
- Novo Nordisk INvestigational Site
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Hazmieh, Lebanon, 9615
- Novo Nordisk INvestigational Site
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Lebanon - Beirut, Lebanon, 9611
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Kuala Lumpur, Malaysia, 59100
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Puebla, Mexico, 72190
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Tamaulipas
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Tampico, Tamaulipas, Mexico, 89170
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Fès, Morocco, 30000
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Rabat, Morocco, 10000
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Den Bosch, Netherlands, 5223GZ
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Grafton, New Zealand, 1023
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Skopje, North Macedonia, 1000
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Bergen, Norway, 5021
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Katowice, Poland, 40-752
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Warszawa, Poland, 04-730
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Wroclaw, Poland, 50-311
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Braga, Portugal, 4710-243
- Novo Nordisk INvestigational Site
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Lisboa, Portugal, 1649-035
- Novo Nordisk INvestigational Site
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Lisboa, Portugal, 1169-045
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Ponce, Puerto Rico, 00717
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Bucharest, Romania, 020614
- Novo Nordisk INvestigational Site
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Bucharest, Romania, 041451
- Novo Nordisk INvestigational Site
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Constanta, Romania, 900591
- Novo Nordisk INvestigational Site
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Timis
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Timisoara, Timis, Romania, 300011
- Novo Nordisk INvestigational Site
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Chelyabinsk, Russian Federation, 454087
- Novo Nordisk INvestigational Site
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Izhevsk, Russian Federation, 426009
- Novo Nordisk INvestigational Site
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Krasnoyarsk, Russian Federation, 660022
- Novo Nordisk INvestigational Site
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Moscow, Russian Federation, 125373
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Moscow, Russian Federation, 117036
- Novo Nordisk INvestigational Site
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Novosibirsk, Russian Federation, 630048
- Novo Nordisk INvestigational Site
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Saint-Petersburg, Russian Federation, 191144
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Saint-Petersburg, Russian Federation, 194100
- Novo Nordisk INvestigational Site
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Saratov, Russian Federation, 410054
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Tomsk, Russian Federation, 634050
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Belgrade, Serbia, 11000
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Belgrade, Serbia, 11070
- Novo Nordisk INvestigational Site
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Nis, Serbia, 18 000
- Novo Nordisk INvestigational Site
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Novi Sad, Serbia, 21000
- Novo Nordisk INvestigational Site
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Leganés, Spain, 28911
- Novo Nordisk INvestigational Site
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Madrid, Spain, 28009
- Novo Nordisk INvestigational Site
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Madrid, Spain, 28046
- Novo Nordisk INvestigational Site
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Vigo, Spain, 36312
- Novo Nordisk INvestigational Site
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Vitoria, Spain, 01009
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Göteborg, Sweden, 416 85
- Novo Nordisk INvestigational Site
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Huddinge, Sweden, 141 57
- Novo Nordisk INvestigational Site
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Uppsala, Sweden, 751 85
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Tainan city, Taiwan, 710
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Taoyuan, Taiwan, 333
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Bangkok, Thailand, 10700
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Chiang Mai, Thailand, 50200
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Ankara, Turkey, 06100
- Novo Nordisk INvestigational Site
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Ankara, Turkey, 06230
- Novo Nordisk INvestigational Site
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Istanbul, Turkey, 34890
- Novo Nordisk INvestigational Site
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Kocaeli, Turkey, 41380
- Novo Nordisk INvestigational Site
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Birmingham, United Kingdom, B4 6NH
- Novo Nordisk INvestigational Site
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London, United Kingdom, SE5 9RS
- Novo Nordisk INvestigational Site
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Manchester, United Kingdom, M13 9WL
- Novo Nordisk INvestigational Site
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Norwich, United Kingdom, NR4 7TJ
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Southampton, United Kingdom, SO16 6YD
- Novo Nordisk INvestigational Site
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Alabama
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Birmingham, Alabama, United States, 35233
- Novo Nordisk INvestigational Site
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Arizona
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Phoenix, Arizona, United States, 85053
- Novo Nordisk INvestigational Site
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Tucson, Arizona, United States, 85724-0001
- Novo Nordisk INvestigational Site
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California
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Corona, California, United States, 92880
- Novo Nordisk INvestigational Site
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Costa Mesa, California, United States, 92626
- Novo Nordisk INvestigational Site
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Long Beach, California, United States, 90806
- Novo Nordisk INvestigational Site
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Los Angeles, California, United States, 90027
- Novo Nordisk INvestigational Site
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Los Angeles, California, United States, 90048-1869
- Novo Nordisk INvestigational Site
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Moreno Valley, California, United States, 92555
- Novo Nordisk INvestigational Site
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Palo Alto, California, United States, 94304-1503
- Novo Nordisk INvestigational Site
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San Diego, California, United States, 92123
- Novo Nordisk INvestigational Site
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Ventura, California, United States, 93003
- Novo Nordisk INvestigational Site
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Connecticut
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New Haven, Connecticut, United States, 06511
- Novo Nordisk INvestigational Site
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Delaware
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Wilmington, Delaware, United States, 19803
- Novo Nordisk INvestigational Site
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District of Columbia
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Washington, District of Columbia, United States, 20011
- Novo Nordisk INvestigational Site
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Florida
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Jacksonville, Florida, United States, 32256
- Novo Nordisk INvestigational Site
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Melbourne, Florida, United States, 32901
- Novo Nordisk INvestigational Site
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Miami, Florida, United States, 33144
- Novo Nordisk INvestigational Site
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Miami, Florida, United States, 33155
- Novo Nordisk INvestigational Site
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Miami, Florida, United States, 33126
- Novo Nordisk INvestigational Site
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Saint Petersburg, Florida, United States, 33701
- Novo Nordisk INvestigational Site
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Tallahassee, Florida, United States, 32308
- Novo Nordisk INvestigational Site
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Tampa, Florida, United States, 33612
- Novo Nordisk INvestigational Site
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Georgia
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Atlanta, Georgia, United States, 30318
- Novo Nordisk INvestigational Site
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Atlanta, Georgia, United States, 30322
- Novo Nordisk INvestigational Site
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Columbus, Georgia, United States, 31904
- Novo Nordisk INvestigational Site
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Indiana
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Bloomington, Indiana, United States, 47401
- Novo Nordisk INvestigational Site
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Iowa
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Iowa City, Iowa, United States, 52242
- Novo Nordisk INvestigational Site
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Kansas
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Topeka, Kansas, United States, 66606
- Novo Nordisk INvestigational Site
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Kentucky
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Lexington, Kentucky, United States, 40503
- Novo Nordisk INvestigational Site
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Lexington, Kentucky, United States, 40536-0284
- Novo Nordisk INvestigational Site
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Maryland
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Silver Spring, Maryland, United States, 20910
- Novo Nordisk INvestigational Site
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Massachusetts
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Worcester, Massachusetts, United States, 01655
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Michigan
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Detroit, Michigan, United States, 48201
- Novo Nordisk INvestigational Site
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Grand Rapids, Michigan, United States, 49503
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Minnesota
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Saint Paul, Minnesota, United States, 55102
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Missouri
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Columbia, Missouri, United States, 65201
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Kansas City, Missouri, United States, 64111
- Novo Nordisk INvestigational Site
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Saint Louis, Missouri, United States, 63104
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Nevada
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Las Vegas, Nevada, United States, 89128
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New Jersey
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Hackensack, New Jersey, United States, 07601
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West Orange, New Jersey, United States, 07052
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New York
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Buffalo, New York, United States, 14203
- Novo Nordisk INvestigational Site
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New York, New York, United States, 10016
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New York, New York, United States, 10003
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New York, New York, United States, 10029
- Novo Nordisk INvestigational Site
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Sleepy Hollow, New York, United States, 10591
- Novo Nordisk INvestigational Site
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Ohio
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Cincinnati, Ohio, United States, 45229
- Novo Nordisk INvestigational Site
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Toledo, Ohio, United States, 43606
- Novo Nordisk INvestigational Site
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Novo Nordisk INvestigational Site
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Philadelphia, Pennsylvania, United States, 19104
- Novo Nordisk INvestigational Site
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Philadelphia, Pennsylvania, United States, 19134
- Novo Nordisk INvestigational Site
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Pittsburgh, Pennsylvania, United States, 15224
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South Carolina
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Greenville, South Carolina, United States, 29615
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South Dakota
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Rapid City, South Dakota, United States, 57701
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- Novo Nordisk INvestigational Site
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Memphis, Tennessee, United States, 38119
- Novo Nordisk INvestigational Site
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Memphis, Tennessee, United States, 38105
- Novo Nordisk INvestigational Site
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Memphis, Tennessee, United States, 38119-3821
- Novo Nordisk INvestigational Site
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Nashville, Tennessee, United States, 37232
- Novo Nordisk INvestigational Site
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Texas
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Amarillo, Texas, United States, 79106
- Novo Nordisk INvestigational Site
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Dallas, Texas, United States, 75235
- Novo Nordisk INvestigational Site
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Edinburg, Texas, United States, 78539
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77061
- Novo Nordisk INvestigational Site
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Houston, Texas, United States, 77054
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Kerrville, Texas, United States, 78028
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San Antonio, Texas, United States, 78233
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Virginia
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Charlottesville, Virginia, United States, 22908
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Norfolk, Virginia, United States, 23507
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West Virginia
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Charleston, West Virginia, United States, 25302
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Lira + Met
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Administered subcutaneously (s.c., under the skin) once daily.1.8
mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks.
Subjects will continue treatment in a 26 week open-labelled extension.
Rescue treatment will be allowed if rescue criteria are met.
Tablets administered for 26 weeks.
Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator.
Subjects will continue treatment in a 26 week open-labelled extension.
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PLACEBO_COMPARATOR: Placebo + Met
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Tablets administered for 26 weeks.
Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator.
Subjects will continue treatment in a 26 week open-labelled extension.
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks.
Subjects will discontinue placebo treatment in the open-labelled extension.
Rescue treatment will be allowed if rescue criteria are met.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in HbA1c (Glycosylated Haemoglobin)
Time Frame: Week 0, week 26
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Change in HbA1c from baseline to week 26.
All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.
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Week 0, week 26
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 26
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Change in FPG from baseline to week 26.
All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
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Week 0, week 26
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Number of Subjects Having HbA1c Below 7.0%
Time Frame: Week 26
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Percentage of subjects having HbA1c <7.0%.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Week 26
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Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)
Time Frame: Week 0, week 26
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Change in BMI SDS from baseline to week 26.
BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Week 0, week 26
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Number of Subjects Having HbA1c Below 7.0%
Time Frame: Week 52
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Number of subjects achieving HbA1c <7.0% after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Week 52
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Number of Subjects Having HbA1c Maximum 6.5%
Time Frame: Week 26
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Number of subjects achieving HbA1c <=6.5% after 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Week 26
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Number of Subjects Having HbA1c Maximum 6.5%
Time Frame: Week 52
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Number of subjects achieving HbA1c <=6.5% after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Week 52
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Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Time Frame: Week 26
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Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 26 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria:
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Week 26
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Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Time Frame: Week 52
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Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 52 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria:
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Week 52
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Number of Subjects Having HbA1c Below 7.5%
Time Frame: Week 26
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Number of subjects achieving HbA1c <7.5% after 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Week 26
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Number of Subjects Having HbA1c Below 7.5%
Time Frame: Week 52
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Number of subjects achieving HbA1c <7.5% after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Week 52
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Change in HbA1c
Time Frame: Week 0, week 52
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Change in HbA1c from baseline to week 52.
All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
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Week 0, week 52
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Change in FPG
Time Frame: Week 0, week 52
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Change in FPG from baseline to week 52.
All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
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Week 0, week 52
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Change in Mean 7-point Self-measured Plasma Glucose
Time Frame: Week 0, week 26
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Change in mean 7-point self-measured plasma glucose after 26 weeks.
Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime.
Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Week 0, week 26
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Change From Baseline in 7-point Self-measured Plasma Glucose
Time Frame: Week 0, week 52
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Change in mean 7-point self-measured plasma glucose after 52 weeks.
Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime.
Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Week 0, week 52
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Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Time Frame: Week 0, week 26
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Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks.
Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
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Week 0, week 26
|
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Time Frame: Week 0, week 52
|
Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks.
Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
Time Frame: Week 0, week 26
|
Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks.
Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
Time Frame: Week 0, week 52
|
Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks.
Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Change From Baseline in Body Weight
Time Frame: Week 0, week 26
|
Change from baseline in body weight after 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Change From Baseline in Body Weight
Time Frame: Week 0, week 52
|
Change from baseline in body weight after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Change From Baseline in BMI Standard Deviation Score (SDS)
Time Frame: Week 0, week 52
|
Change in BMI SDS from baseline to week 52.
BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Time Frame: Week 0, week 26
|
Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Time Frame: Week 0, week 52
|
Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Fasting Insulin
Time Frame: Week 0, week 26
|
Ratio to baseline (fasting insulin) at week 26.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: Fasting Insulin
Time Frame: Week 0, week 52
|
Ratio to baseline (fasting insulin) at week 52.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Fasting Pro-insulin
Time Frame: Week 0, week 26
|
Ratio to baseline (fasting pro-insulin) at week 26.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: Fasting Pro-insulin
Time Frame: Week 0, week 52
|
Ratio to baseline (fasting pro-insulin) at week 52.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Pro-insulin/Insulin Ratio
Time Frame: Week 0, week 26
|
Ratio to baseline (Pro-insulin/insulin ratio) after week 26.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: Pro-insulin/Insulin Ratio
Time Frame: Week 0, week 52
|
Ratio to baseline (Pro-insulin/insulin ratio) after week 52.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Fasting Glucagon
Time Frame: Week 0, week 26
|
Ratio to baseline (fasting glucagon) at week 26.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: Fasting Glucagon
Time Frame: Week 0, week 52
|
Ratio to baseline (fasting glucagon) at week 52.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Fasting C-peptide
Time Frame: Week 0, week 26
|
Ratio to baseline (fasting C-peptide) at week 26.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: Fasting C-peptide
Time Frame: Week 0, week 52
|
Ratio to baseline (fasting C-peptide) at week 52.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
Time Frame: Week 0, week 26
|
Ratio to baseline (HOMA-B) after 26 weeks.
HOMA-B is an index of beta-cell function and was calculated from fasting insulin.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: HOMA-B
Time Frame: Week 0, week 52
|
Ratio to baseline (HOMA-B) after 52 weeks.
HOMA-B is an index of beta-cell function and was calculated from fasting insulin.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
Time Frame: Week 0, week 26
|
Ratio to baseline (HOMA-IR) after 26 weeks.
HOMA-IR is an index of insulin resistance and was calculated from fasting insulin.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: HOMA-IR
Time Frame: Week 0, week 52
|
Ratio to baseline (HOMA-IR) after 52 weeks.
HOMA-IR is an index of insulin resistance and was calculated from fasting insulin.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Total Cholesterol
Time Frame: Week 0, week 26
|
Ratio to baseline (total cholesterol) after 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: Total Cholesterol
Time Frame: Week 0, week 52
|
Ratio to baseline (total cholesterol) after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol
Time Frame: Week 0, week 26
|
Ratio to baseline (LDL cholesterol) after 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: LDL Cholesterol
Time Frame: Week 0, week 52
|
Ratio to baseline (LDL cholesterol) after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol
Time Frame: Week 0, week 26
|
Ratio to baseline (VLDL cholesterol) after 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: VLDL Cholesterol
Time Frame: Week 0, week 52
|
Ratio to baseline (VLDL cholesterol) after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol
Time Frame: Week 0, week 26
|
Ratio to baseline (HDL cholesterol) after 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: HDL Cholesterol
Time Frame: Week 0, week 52
|
Ratio to baseline (HDL cholesterol) after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Triglycerides
Time Frame: Week 0, week 26
|
Ratio to baseline (triglycerides) after 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: Triglycerides
Time Frame: Week 0, week 52
|
Ratio to baseline (triglycerides) after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Ratio to Baseline: Free Fatty Acids
Time Frame: Week 0, week 26
|
Ratio to baseline (free fatty acids) after 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Ratio to Baseline: Free Fatty Acids
Time Frame: Week 0, week 52
|
Ratio to baseline (free fatty acids) after 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Change From Baseline in Pulse
Time Frame: Week 0, week 26
|
Change from baseline in pulse 26 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Change From Baseline in Pulse
Time Frame: Week 0, week 52
|
Change from baseline in pulse 52 weeks.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Change From Baseline in Height SDS
Time Frame: Week 0, week 26
|
Change in height SDS from baseline to week 26.
Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Change From Baseline in Height SDS
Time Frame: Week 0, week 52
|
Change in height SDS from baseline to week 52.
Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Change in Bone Age Assessment (X-ray of Left Hand and Wrist)
Time Frame: Week 0, week 52
|
Change in bone age from baseline to week 52.
If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52.
|
Week 0, week 52
|
Pubertal Assessment/Progression (Tanner Staging)
Time Frame: Week 0, week 26, week 52
|
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V.
The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator.
Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52.
|
Week 0, week 26, week 52
|
Growth (Height Velocity)
Time Frame: Week 0, week 26
|
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year.
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
|
Week 0, week 26
|
Growth (Height Velocity)
Time Frame: Week 0, week 52
|
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year.
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
|
Week 0, week 52
|
Height Velocity SDS
Time Frame: Week 0, week 26
|
Height velocity SDS scores at week 26.
Height velocity is change in height per year.
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days.
Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 26
|
Height Velocity SDS
Time Frame: Week 0, week 52
|
Height velocity SDS scores at week 52.
Height velocity is change in height per year.
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days.
Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
|
Week 0, week 52
|
Number of Hypoglycaemic Episodes
Time Frame: 0-26 weeks
|
Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26.
|
0-26 weeks
|
Number of Hypoglycaemic Episodes
Time Frame: 0-52 weeks
|
Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52.
|
0-52 weeks
|
Number of Adverse Events (Week 0-26)
Time Frame: 0-26 weeks
|
Total number of adverse events during 26 weeks.
|
0-26 weeks
|
Number of Adverse Events (Week 0-52)
Time Frame: 0-52 weeks
|
Total number of adverse events during entire treatment period.
|
0-52 weeks
|
Number of Serious Adverse Events (Week 0-26)
Time Frame: 0-26 weeks
|
Total number of serious adverse events during 26 weeks.
|
0-26 weeks
|
Number of Serious Adverse Events (Week 0-52)
Time Frame: 0-52 weeks
|
Total number of serious adverse events during entire treatment period.
|
0-52 weeks
|
Number of Adverse Events (Week 53-104)
Time Frame: Week 53-104
|
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Number of adverse events reported during follow-up 1 (week 53 to 104).
|
Week 53-104
|
Number of Serious Adverse Events (Week 53-104)
Time Frame: Weeks 53-104
|
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Number of serious adverse events reported during follow up 1 (week 53 to 104).
|
Weeks 53-104
|
Growth (Height Velocity)- Week 104
Time Frame: Week 0, week 104
|
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year.
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
|
Week 0, week 104
|
Height Velocity SDS- Week 104
Time Frame: Week 0, week 104
|
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days.
Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
|
Week 0, week 104
|
Change From Week 52 in Height SDS- Week 104
Time Frame: Week 52, week 104
|
Change in height SDS from week 52 to week 104.
Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
|
Week 52, week 104
|
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104
Time Frame: Week 52, week 104
|
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult".
The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator.
Reported results are number of subjects at different Tanner stages at week 52 and week 104.
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
|
Week 52, week 104
|
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104
Time Frame: Week 52, week 104
|
Change in bone age from week 52 to week 104.
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
|
Week 52, week 104
|
Number of Adverse Events (Week 53-156)
Time Frame: Week 53-156
|
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Number of adverse events reported during the follow-up period (weeks 53 to 156).
|
Week 53-156
|
Number of Serious Adverse Events (Week 53-156)
Time Frame: Weeks 53-156
|
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Number of serious adverse events reported during the follow up period (week 53 to 156).
|
Weeks 53-156
|
Growth (Height Velocity)- Week 156
Time Frame: Week 0, week 156
|
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year.
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
|
Week 0, week 156
|
Height Velocity SDS- Week 156
Time Frame: Week 0, week 156
|
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days.
Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
|
Week 0, week 156
|
Change From Week 52 in Height SDS- Week 156
Time Frame: Week 52, week 156
|
Change in height SDS from week 52 to week 156.
Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
|
Week 52, week 156
|
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156
Time Frame: Week 52, week 156
|
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult".
The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator.
Reported results are number of subjects at different Tanner stages at week 52 and week 156.
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
|
Week 52, week 156
|
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156
Time Frame: Week 52, week 156
|
Change in bone age from week 52 to week 156.
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
|
Week 52, week 156
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Tamborlane WV, Barrientos-Perez M, Fainberg U, Frimer-Larsen H, Hafez M, Hale PM, Jalaludin MY, Kovarenko M, Libman I, Lynch JL, Rao P, Shehadeh N, Turan S, Weghuber D, Barrett T; Ellipse Trial Investigators. Liraglutide in Children and Adolescents with Type 2 Diabetes. N Engl J Med. 2019 Aug 15;381(7):637-646. doi: 10.1056/NEJMoa1903822. Epub 2019 Apr 28.
- Bensignor MO, Bomberg EM, Bramante CT, Divyalasya TVS, Hale PM, Ramesh CK, Rudser KD, Kelly AS. Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial. Pediatr Obes. 2021 Aug;16(8):e12778. doi: 10.1111/ijpo.12778. Epub 2021 Feb 25.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN2211-3659
- 2011-002605-29 (EUDRACT_NUMBER)
- P/288/2010 (OTHER: EMA (PDCO))
- U1111-1121-8743 (OTHER: WHO)
- CTRI/2013/10/004082 (REGISTRY: Clinical Trials Registry - India (CTRI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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