Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
NCT ID: NCT01272232
Last Updated: 2017-12-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
846 participants
INTERVENTIONAL
2011-06-01
2013-01-25
Brief Summary
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The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea \[SU\] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.
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 3.0 mg
liraglutide
Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Lira 1.8 mg
liraglutide
Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Placebo
placebo
Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Interventions
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placebo
Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
liraglutide
Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
liraglutide
Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
Eligibility Criteria
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Inclusion Criteria
* Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of the previously mentioned compounds
* HbA1c 7.0-10.0% (both inclusive)
* Body Mass Index (BMI) at least 27.0 kg/m\^2
* Stable body weight
* Preceding failed dietary effort
Exclusion Criteria
* Known proliferative retinopathy or maculopathy
* History of acute or chronic pancreatitis
* Obesity induced by drug treatment
* Use of approved weight lowering pharmacotherapy
* Previous surgical treatment of obesity
* History of major depressive disorder or suicide attempt
* Uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
* Screening calcitonin of 50 ng/L or above
* Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
* Personal history of non-familial medullary thyroid carcinoma
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Vestavia Hills, Alabama, United States
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Peoria, Arizona, United States
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Jonesboro, Arkansas, United States
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Concord, 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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Mission Hills, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Arvada, Colorado, United States
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Brooksville, Florida, United States
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Clearwater, Florida, United States
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Hollywood, Florida, United States
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Kissimmee, Florida, United States
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Plantation, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Roswell, Georgia, United States
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Honolulu, Hawaii, United States
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Meridian, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Columbia, Maryland, United States
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Hyattsville, Maryland, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Lawrenceville, New Jersey, United States
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Toms River, New Jersey, United States
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Albany, New York, United States
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Endwell, New York, United States
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Asheville, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Anderson, South Carolina, United States
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Moncks Corner, South Carolina, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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St. George, Utah, United States
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Newport News, Virginia, United States
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Olympia, Washington, United States
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Bondy, , France
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La Rochelle, , France
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Le Creusot, , France
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Nanterre, , France
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Narbonne, , France
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Pointe à Pitre, , France
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Saint-Herblain, , France
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Vénissieux, , France
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Gebhardshain, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Hohenmölsen, , Germany
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Münster, , Germany
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Schkeuditz, , Germany
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Stuttgart, , Germany
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Wangen, , Germany
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Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
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Kolkata, West Bengal, India
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Pune, , India
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Thriruvananthapuram, , India
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Beersheba, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Rishon LeZiyyon, , Israel
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Tel Litwinsky, , Israel
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Catanzaro, , Italy
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Chieti Scalo, , Italy
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Florence, , Italy
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Forlì, , Italy
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Latina, , Italy
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Milan, , Italy
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Padua, , Italy
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Perugia, , Italy
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Pistoia, , Italy
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San Juan, , Puerto Rico
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Port Elizabeth, Eastern Cape, South Africa
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Bloemfontein, Free State, South Africa
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Johannesburg, Gauteng, South Africa
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Lenasia, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Brits, North West, South Africa
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Cape Town, Western Cape, South Africa
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Cape Town, Western Cape, South Africa
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Granada, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Palma de Mallorca, , Spain
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Partida de Bacarot, , Spain
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Seville, , Spain
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Seville, , Spain
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Seville, , Spain
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Ängelholm, , Sweden
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Dalby, , Sweden
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Luleå, , Sweden
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Lund, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taoyuan District, , Taiwan
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Ankara, , Turkey (Türkiye)
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Gaziantep, , Turkey (Türkiye)
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Hatay, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kahramanmaraş, , Turkey (Türkiye)
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Airdrie, , United Kingdom
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Ayr, , United Kingdom
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Bexhill-on-Sea, , United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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Cambridge, , United Kingdom
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Chester, , United Kingdom
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Darlington, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Middlesbrough, , United Kingdom
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Nottingham, , United Kingdom
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Plymouth, , United Kingdom
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Rotherham, , United Kingdom
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Swansea, , United Kingdom
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Truro, , United Kingdom
Countries
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References
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le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m(2): A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17.
Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422. doi: 10.1007/s40262-016-0410-7.
O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2.
Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjoth TV, Bjorn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629.
Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.
Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjoth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11.
Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1.
Davies MJ, Bergenstal R, Bode B, Kushner RF, Lewin A, Skjoth TV, Andreasen AH, Jensen CB, DeFronzo RA; NN8022-1922 Study Group. Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial. JAMA. 2015 Aug 18;314(7):687-99. doi: 10.1001/jama.2015.9676.
McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.
Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.
von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11.
O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.
Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2008-002199-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1118-7963
Identifier Type: OTHER
Identifier Source: secondary_id
NN8022-1922
Identifier Type: -
Identifier Source: org_study_id