Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
NCT ID: NCT01541215
Last Updated: 2021-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
135 participants
INTERVENTIONAL
2012-11-13
2020-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lira + Met
liraglutide
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.
metformin
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 + Met
placebo
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.
metformin
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.
Interventions
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liraglutide
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.
placebo
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.
metformin
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
10 Years
17 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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Novo Nordisk Investigational Site
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Corona, California, United States
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Costa Mesa, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Moreno Valley, California, United States
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Palo Alto, California, United States
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San Diego, California, United States
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Ventura, California, United States
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New Haven, Connecticut, United States
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Wilmington, Delaware, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Bloomington, Indiana, United States
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Iowa City, Iowa, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Silver Spring, Maryland, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Saint Paul, Minnesota, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Hackensack, New Jersey, United States
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West Orange, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Sleepy Hollow, New York, United States
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Cincinnati, Ohio, United States
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Toledo, Ohio, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Greenville, South Carolina, United States
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Rapid City, South Dakota, United States
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Chattanooga, Tennessee, United States
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Memphis, Tennessee, United States
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Memphis, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Dallas, Texas, United States
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Edinburg, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Kerrville, Texas, United States
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San Antonio, Texas, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Charleston, West Virginia, United States
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Ipswich, Queensland, Australia
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Graz, , Austria
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Innsbruck, , Austria
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Salzburg, , Austria
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Wels, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Leuven, , Belgium
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Porto Alegre, Rio Grande do Sul, Brazil
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Brampton, Ontario, Canada
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Westmount, Quebec, Canada
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Rijeka, , Croatia
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Zagreb, , Croatia
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Herlev, , Denmark
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Næstved, , Denmark
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Al Mansurah, , Egypt
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Alexandria, , Egypt
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Cairo, , Egypt
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Cairo, , Egypt
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Marseille, , France
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Montpellier, , France
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Ludwigshafen, , Germany
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Mayen, , Germany
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Athens, , Greece
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Athens, , Greece
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Goudi/ Athens, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Miskolc, , Hungary
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Szombathely, , Hungary
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Guntur, Andhra Pradesh, India
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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Mumbai, Maharashtra, India
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Mumbai, Maharashtra, India
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Pune, Maharashtra, India
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New Dehli, New Delhi, India
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Chandigarh, Punjab, India
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Ludhiana, Punjab, India
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Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
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Hyderbad, Telangana, India
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Kolkata, West Bengal, India
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Kolkata, , India
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Tel Litwinsky, , Israel
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Roma, , Italy
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Hazmiyeh, , Lebanon
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Lebanon - Beirut, , Lebanon
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Kuala Lumpur, , Malaysia
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Tampico, Tamaulipas, Mexico
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Puebla City, , Mexico
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Fes, , Morocco
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Rabat, , Morocco
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's-Hertogenbosch, , Netherlands
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Grafton, , New Zealand
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Skopje, , North Macedonia
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Bergen, , Norway
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Katowice, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Braga, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Ponce, , Puerto Rico
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Timișoara, Timiș County, Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Constanța, , Romania
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Chelyabinsk, , Russia
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Izhevsk, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Tomsk, , Russia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Niš, , Serbia
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Novi Sad, , Serbia
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Leganés, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Vigo, , Spain
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Vitoria-Gasteiz, , Spain
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Gothenburg, , Sweden
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Huddinge, , Sweden
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Uppsala, , Sweden
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Tainan City, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Norwich, , United Kingdom
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Southampton, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2011-002605-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P/288/2010
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1121-8743
Identifier Type: OTHER
Identifier Source: secondary_id
CTRI/2013/10/004082
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN2211-3659
Identifier Type: -
Identifier Source: org_study_id
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