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Clinical Trial Details

Trial ID: L5977
Source ID: NCT01272232
Associated Drug: Liraglutide
Title: Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01272232/results
Conditions: Metabolism and Nutrition Disorder|Obesity
Interventions: DRUG: liraglutide|DRUG: liraglutide|DRUG: placebo
Outcome Measures: Primary: Change (%) From Baseline in Body Weight (Fasting), Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial., Week 0, week 56|Proportion of Subjects Losing at Least 5% of Baseline Body Weight, Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial., at 56 weeks|Proportion of Subjects Losing More Than 10% of Baseline Body Weight, Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial., at 56 weeks | Secondary: Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c), Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56., Week 0, week 56|Proportion of Subjects Reaching Target HbA1c Below 7%, at 56 weeks|Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%, at 56 weeks|Change From Baseline in Waist Circumference, Week 0, week 56|Change (%) From Baseline in Body Weight (Fasting), Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial., Week 0, week 68|Change (%) From Week 56 to 68 in Body Weight (Fasting), Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial., Week 56, week 68|Change From Baseline in Waist Circumference, Week 0, week 68|Change From Week 56 to 68 in Waist Circumference, Week 56, week 68|Incidence of Hypoglycaemic Episodes, Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L \[50 mg/dL\] or plasma glucose level below 3.1 mmol/L \[56 mg/dL\])., Weeks 0-56
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 846
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-06-01
Completion Date: 2013-01-25
Results First Posted: 2015-02-09
Last Update Posted: 2017-12-29
Locations: Novo Nordisk Investigational Site, Vestavia Hills, Alabama, 35209, United States|Novo Nordisk Investigational Site, Peoria, Arizona, 85381, United States|Novo Nordisk Investigational Site, Jonesboro, Arkansas, 72401, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Long Beach, California, 90807, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Mission Hills, California, 91345, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Tustin, California, 92780, United States|Novo Nordisk Investigational Site, Arvada, Colorado, 80005, United States|Novo Nordisk Investigational Site, Brooksville, Florida, 34601, United States|Novo Nordisk Investigational Site, Clearwater, Florida, 33765, United States|Novo Nordisk Investigational Site, Hollywood, Florida, 33021, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, Tampa, Florida, 33603, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Columbus, Georgia, 31904, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Meridian, Idaho, 83642, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60611-5975, United States|Novo Nordisk Investigational Site, Springfield, Illinois, 62711, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Louisville, Kentucky, 40213, United States|Novo Nordisk Investigational Site, New Orleans, Louisiana, 70121, United States|Novo Nordisk Investigational Site, Columbia, Maryland, 21045, United States|Novo Nordisk Investigational Site, Hyattsville, Maryland, 20782, United States|Novo Nordisk Investigational Site, Southfield, Michigan, 48034-7661, United States|Novo Nordisk Investigational Site, Minneapolis, Minnesota, 55416, United States|Novo Nordisk Investigational Site, Saint Louis, Missouri, 63110, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Toms River, New Jersey, 08755-8050, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Endwell, New York, 13760, United States|Novo Nordisk Investigational Site, Asheville, North Carolina, 28803, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Hickory, North Carolina, 28602, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557, United States|Novo Nordisk Investigational Site, Raleigh, North Carolina, 27609, United States|Novo Nordisk Investigational Site, Salisbury, North Carolina, 28144, United States|Novo Nordisk Investigational Site, Wilmington, North Carolina, 28401, United States|Novo Nordisk Investigational Site, Winston-Salem, North Carolina, 27103, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45255, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73104, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19107, United States|Novo Nordisk Investigational Site, Anderson, South Carolina, 29621, United States|Novo Nordisk Investigational Site, Moncks Corner, South Carolina, 29461, United States|Novo Nordisk Investigational Site, Bristol, Tennessee, 37620, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37212, United States|Novo Nordisk Investigational Site, Austin, Texas, 78728, United States|Novo Nordisk Investigational Site, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78207-5209, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78240, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78258, United States|Novo Nordisk Investigational Site, Saint George, Utah, 84790, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84102, United States|Novo Nordisk Investigational Site, Newport News, Virginia, 23606, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Bondy, 93143, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, Nanterre, 92014, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, Pointe À Pitre, 97139, France|Novo Nordisk Investigational Site, Saint Herblain, 44800, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Berlin, 12157, Germany|Novo Nordisk Investigational Site, Berlin, 12163, Germany|Novo Nordisk Investigational Site, Berlin, 12203, Germany|Novo Nordisk Investigational Site, Dresden, 01307, Germany|Novo Nordisk Investigational Site, Dresden, 01309, Germany|Novo Nordisk Investigational Site, Gebhardshain, 57580, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Heidelberg, 69120, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Schkeuditz, 04435, Germany|Novo Nordisk Investigational Site, Stuttgart, 70378, Germany|Novo Nordisk Investigational Site, Wangen, 88239, Germany|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302006, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600086, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700020, India|Novo Nordisk Investigational Site, Pune, 411011, India|Novo Nordisk Investigational Site, Thriruvananthapuram, 695 032, India|Novo Nordisk Investigational Site, Beer Sheva, 84101, Israel|Novo Nordisk Investigational Site, Haifa, 31096, Israel|Novo Nordisk Investigational Site, Haifa, 35152, Israel|Novo Nordisk Investigational Site, Jerusalem, 91120, Israel|Novo Nordisk Investigational Site, Rishon Le Zion, 75650, Israel|Novo Nordisk Investigational Site, Tel Hashomer, 52621, Israel|Novo Nordisk Investigational Site, Catanzaro, 88100, Italy|Novo Nordisk Investigational Site, Chieti Scalo, 66100, Italy|Novo Nordisk Investigational Site, Firenze, 50141, Italy|Novo Nordisk Investigational Site, Forlì, 47100, Italy|Novo Nordisk Investigational Site, Latina, 04100, Italy|Novo Nordisk Investigational Site, Milano, 20132, Italy|Novo Nordisk Investigational Site, Padova, 35143, Italy|Novo Nordisk Investigational Site, Perugia, 06126, Italy|Novo Nordisk Investigational Site, Pistoia, 51100, Italy|Novo Nordisk Investigational Site, San Juan, 00921, Puerto Rico|Novo Nordisk Investigational Site, Port Elizabeth, Eastern Cape, 6045, South Africa|Novo Nordisk Investigational Site, Bloemfontein, Free State, 9301, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 2194, South Africa|Novo Nordisk Investigational Site, Lenasia, Gauteng, 1827, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0001, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4001, South Africa|Novo Nordisk Investigational Site, Brits, North West, 0250, South Africa|Novo Nordisk Investigational Site, Cape Town, Western Cape, 7460, South Africa|Novo Nordisk Investigational Site, Cape Town, Western Cape, 7708, South Africa|Novo Nordisk Investigational Site, Granada, 18012, Spain|Novo Nordisk Investigational Site, Madrid, 28007, Spain|Novo Nordisk Investigational Site, Madrid, 28034, Spain|Novo Nordisk Investigational Site, Palma de Mallorca, 07010, Spain|Novo Nordisk Investigational Site, Partida De Bacarot, 03114, Spain|Novo Nordisk Investigational Site, Sevilla, 41009, Spain|Novo Nordisk Investigational Site, Sevilla, 41010, Spain|Novo Nordisk Investigational Site, Sevilla, 41014, Spain|Novo Nordisk Investigational Site, Dalby, 240 10, Sweden|Novo Nordisk Investigational Site, Göteborg, 416 65, Sweden|Novo Nordisk Investigational Site, Göteborg, 417 17, Sweden|Novo Nordisk Investigational Site, Luleå, 972 33, Sweden|Novo Nordisk Investigational Site, Lund, 221 85, Sweden|Novo Nordisk Investigational Site, Stockholm, 112 81, Sweden|Novo Nordisk Investigational Site, Stockholm, 141 86, Sweden|Novo Nordisk Investigational Site, Ängelholm, 262 81, Sweden|Novo Nordisk Investigational Site, Örebro, 701 85, Sweden|Novo Nordisk Investigational Site, Taichung, 404, Taiwan|Novo Nordisk Investigational Site, Tainan city, 710, Taiwan|Novo Nordisk Investigational Site, Taoyuan, 333, Taiwan|Novo Nordisk Investigational Site, Ankara, 06100, Turkey|Novo Nordisk Investigational Site, Gaziantep, 27070, Turkey|Novo Nordisk Investigational Site, Hatay, 31040, Turkey|Novo Nordisk Investigational Site, Istanbul, 34096, Turkey|Novo Nordisk Investigational Site, Izmir, 35340, Turkey|Novo Nordisk Investigational Site, Kahramanmaras, 46000, Turkey|Novo Nordisk Investigational Site, Airdrie, ML6 0JS, United Kingdom|Novo Nordisk Investigational Site, Ayr, KA6 6DX, United Kingdom|Novo Nordisk Investigational Site, Bexhill-on-Sea, TN39 4SP, United Kingdom|Novo Nordisk Investigational Site, Birmingham, B9 5SS, United Kingdom|Novo Nordisk Investigational Site, Bristol, BS10 5NB, United Kingdom|Novo Nordisk Investigational Site, Cambridge, CB2 2QQ, United Kingdom|Novo Nordisk Investigational Site, Chester, CH2 1UL, United Kingdom|Novo Nordisk Investigational Site, Darlington, DL2 1AA, United Kingdom|Novo Nordisk Investigational Site, Leeds, LS25 1AN, United Kingdom|Novo Nordisk Investigational Site, Leicester, LE5 4PW, United Kingdom|Novo Nordisk Investigational Site, London, E1 2EF, United Kingdom|Novo Nordisk Investigational Site, Middlesbrough, TS4 3BW, United Kingdom|Novo Nordisk Investigational Site, Nottingham, NG7 2UH, United Kingdom|Novo Nordisk Investigational Site, Plymouth, PL6 8BQ, United Kingdom|Novo Nordisk Investigational Site, Rotherham, S651DA, United Kingdom|Novo Nordisk Investigational Site, Swansea, SA6 6NL, United Kingdom|Novo Nordisk Investigational Site, Truro, TR1 3LJ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01272232

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress