Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes (Ellipse™)

July 1, 2021 updated by: Novo Nordisk A/S

Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.

Study Overview

Study Type

Interventional

Enrollment (Actual)

135

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

    • Queensland
      • Ipswich, Queensland, Australia, 4305
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      • Graz, Austria, 8036
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      • Innsbruck, Austria, 6020
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      • Salzburg, Austria, 5020
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      • Wels, Austria, 4600
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      • Brussel, Belgium, 1090
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      • Bruxelles, Belgium, 1200
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      • Leuven, Belgium, 3000
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    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-250
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    • Alberta
      • Edmonton, Alberta, Canada, T5X 3N5
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    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
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    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
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    • Quebec
      • 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
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      • Cairo, Egypt, 11562
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      • Cairo, Egypt, 11628
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      • Mansoura, Egypt, 35516
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      • MONTPELLIER cedex 05, France, 34295
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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
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      • Athens, Greece, 151 23
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      • Goudi/ Athens, Greece, GR-11527
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      • Thessaloniki, Greece, GR-54643
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      • Budapest, Hungary, 1089
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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
      • Guntur, Andhra Pradesh, India, 522001
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      • Hyderabad, Andhra Pradesh, India, 500072
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    • Karnataka
      • Bangalore, Karnataka, India, 560054
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      • Bangalore, Karnataka, India, 560 017
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      • Bangalore, Karnataka, India, 560041
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      • Bangalore, Karnataka, India, 560052
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    • Maharashtra
      • 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
      • New Dehli, New Delhi, India, 110029
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    • Punjab
      • Chandigarh, Punjab, India, 160012
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      • Ludhiana, Punjab, India, 141001
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    • Rajasthan
      • Jaipur, Rajasthan, India, 302006
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    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
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    • Telengana
      • Hyderbad, Telengana, India, 500 012
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    • West Bengal
      • Kolkata, West Bengal, India, 700020
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      • Beer Sheva, Israel, 84101
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      • Haifa, Israel, 31096
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      • Jerusalem, Israel, 91240
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      • Petah Tikva, Israel, 49202
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      • Tel Hashomer, Israel, 52621
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      • Roma, Italy, 00165
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      • Hazmieh, Lebanon, 9615
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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
      • 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
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      • Lisboa, Portugal, 1649-035
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      • Lisboa, Portugal, 1169-045
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      • Ponce, Puerto Rico, 00717
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      • Bucharest, Romania, 020614
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      • Bucharest, Romania, 041451
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      • Constanta, Romania, 900591
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    • Timis
      • Timisoara, Timis, Romania, 300011
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      • Chelyabinsk, Russian Federation, 454087
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      • Izhevsk, Russian Federation, 426009
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      • Krasnoyarsk, Russian Federation, 660022
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      • Moscow, Russian Federation, 125373
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      • Moscow, Russian Federation, 117036
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      • Novosibirsk, Russian Federation, 630048
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      • Saint-Petersburg, Russian Federation, 191144
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      • Saint-Petersburg, Russian Federation, 194100
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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
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      • Nis, Serbia, 18 000
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      • Novi Sad, Serbia, 21000
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      • Leganés, Spain, 28911
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      • Madrid, Spain, 28009
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      • Madrid, Spain, 28046
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      • Vigo, Spain, 36312
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      • Vitoria, Spain, 01009
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      • Göteborg, Sweden, 416 85
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      • Huddinge, Sweden, 141 57
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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
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      • Ankara, Turkey, 06230
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      • Istanbul, Turkey, 34890
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      • Kocaeli, Turkey, 41380
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      • Birmingham, United Kingdom, B4 6NH
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      • London, United Kingdom, SE5 9RS
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      • Manchester, United Kingdom, M13 9WL
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      • Norwich, United Kingdom, NR4 7TJ
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      • Southampton, United Kingdom, SO16 6YD
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    • Alabama
      • Birmingham, Alabama, United States, 35233
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    • Arizona
      • Phoenix, Arizona, United States, 85053
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      • Tucson, Arizona, United States, 85724-0001
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    • California
      • Corona, California, United States, 92880
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      • Costa Mesa, California, United States, 92626
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      • Long Beach, California, United States, 90806
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      • Los Angeles, California, United States, 90027
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      • Los Angeles, California, United States, 90048-1869
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      • Moreno Valley, California, United States, 92555
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      • Palo Alto, California, United States, 94304-1503
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      • San Diego, California, United States, 92123
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      • Ventura, California, United States, 93003
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    • Connecticut
      • New Haven, Connecticut, United States, 06511
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    • Delaware
      • Wilmington, Delaware, United States, 19803
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    • District of Columbia
      • Washington, District of Columbia, United States, 20011
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    • Florida
      • Jacksonville, Florida, United States, 32256
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      • Melbourne, Florida, United States, 32901
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      • Miami, Florida, United States, 33144
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      • Miami, Florida, United States, 33155
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      • Miami, Florida, United States, 33126
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      • Saint Petersburg, Florida, United States, 33701
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      • Tallahassee, Florida, United States, 32308
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      • Tampa, Florida, United States, 33612
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    • Georgia
      • Atlanta, Georgia, United States, 30318
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      • Atlanta, Georgia, United States, 30322
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      • Columbus, Georgia, United States, 31904
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    • Indiana
      • Bloomington, Indiana, United States, 47401
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    • Iowa
      • Iowa City, Iowa, United States, 52242
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    • Kansas
      • Topeka, Kansas, United States, 66606
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    • Kentucky
      • Lexington, Kentucky, United States, 40503
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      • Lexington, Kentucky, United States, 40536-0284
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    • Maryland
      • Silver Spring, Maryland, United States, 20910
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    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
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    • Michigan
      • Detroit, Michigan, United States, 48201
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      • Grand Rapids, Michigan, United States, 49503
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    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
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    • Missouri
      • Columbia, Missouri, United States, 65201
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      • Kansas City, Missouri, United States, 64111
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      • Saint Louis, Missouri, United States, 63104
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    • Nevada
      • Las Vegas, Nevada, United States, 89128
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    • New Jersey
      • Hackensack, New Jersey, United States, 07601
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      • West Orange, New Jersey, United States, 07052
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    • New York
      • Buffalo, New York, United States, 14203
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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
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      • Sleepy Hollow, New York, United States, 10591
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    • Ohio
      • Cincinnati, Ohio, United States, 45229
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      • Toledo, Ohio, United States, 43606
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    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
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      • Philadelphia, Pennsylvania, United States, 19104
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      • Philadelphia, Pennsylvania, United States, 19134
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      • Pittsburgh, Pennsylvania, United States, 15224
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    • South Carolina
      • Greenville, South Carolina, United States, 29615
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    • South Dakota
      • Rapid City, South Dakota, United States, 57701
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    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
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      • Memphis, Tennessee, United States, 38119
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      • Memphis, Tennessee, United States, 38105
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      • Memphis, Tennessee, United States, 38119-3821
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      • Nashville, Tennessee, United States, 37232
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    • Texas
      • Amarillo, Texas, United States, 79106
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      • Dallas, Texas, United States, 75235
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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
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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
      • Charlottesville, Virginia, United States, 22908
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      • Norfolk, Virginia, United States, 23507
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    • West Virginia
      • Charleston, West Virginia, United States, 25302
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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

10 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: - Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - Body mass index (BMI) above 85% percentile of the general age and gender matched population Exclusion Criteria: - Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lira + Met
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.
PLACEBO_COMPARATOR: Placebo + 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (Glycosylated Haemoglobin)
Time Frame: Week 0, week 26
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.
Week 0, week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 26
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.
Week 0, week 26
Number of Subjects Having HbA1c Below 7.0%
Time Frame: Week 26
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.
Week 26
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)
Time Frame: Week 0, week 26
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.
Week 0, week 26
Number of Subjects Having HbA1c Below 7.0%
Time Frame: Week 52
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.
Week 52
Number of Subjects Having HbA1c Maximum 6.5%
Time Frame: Week 26
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.
Week 26
Number of Subjects Having HbA1c Maximum 6.5%
Time Frame: Week 52
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.
Week 52
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Time Frame: Week 26

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:

  1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself
  2. any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Week 26
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Time Frame: Week 52

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:

  1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself
  2. any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Week 52
Number of Subjects Having HbA1c Below 7.5%
Time Frame: Week 26
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.
Week 26
Number of Subjects Having HbA1c Below 7.5%
Time Frame: Week 52
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.
Week 52
Change in HbA1c
Time Frame: Week 0, week 52
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.
Week 0, week 52
Change in FPG
Time Frame: Week 0, week 52
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.
Week 0, week 52
Change in Mean 7-point Self-measured Plasma Glucose
Time Frame: Week 0, week 26
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.
Week 0, week 26
Change From Baseline in 7-point Self-measured Plasma Glucose
Time Frame: Week 0, week 52
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.
Week 0, week 52
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Time Frame: Week 0, week 26
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.
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

This is where you will find people and organizations involved with this study.

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.

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 (ACTUAL)

November 13, 2012

Primary Completion (ACTUAL)

November 15, 2017

Study Completion (ACTUAL)

May 20, 2020

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (ESTIMATE)

February 29, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

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)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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