Obesity Clinical Trial
Official title:
Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period
| Verified date | December 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
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.
| Status | Completed |
| Enrollment | 846 |
| Est. completion date | January 25, 2013 |
| Est. primary completion date | January 1, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Informed consent obtained - 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: - Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Novo Nordisk Investigational Site | Bondy | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Le Creusot | |
| France | Novo Nordisk Investigational Site | Nanterre | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | Pointe À Pitre | |
| France | Novo Nordisk Investigational Site | Saint Herblain | |
| France | Novo Nordisk Investigational Site | Venissieux | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Gebhardshain | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Heidelberg | |
| Germany | Novo Nordisk Investigational Site | Hohenmölsen | |
| Germany | Novo Nordisk Investigational Site | Münster | |
| Germany | Novo Nordisk Investigational Site | Schkeuditz | |
| Germany | Novo Nordisk Investigational Site | Stuttgart | |
| Germany | Novo Nordisk Investigational Site | Wangen | |
| India | Novo Nordisk Investigational Site | Chennai | Tamil Nadu |
| India | Novo Nordisk Investigational Site | Jaipur | Rajasthan |
| India | Novo Nordisk Investigational Site | Kolkata | West Bengal |
| India | Novo Nordisk Investigational Site | Pune | |
| India | Novo Nordisk Investigational Site | Thriruvananthapuram | |
| Israel | Novo Nordisk Investigational Site | Beer Sheva | |
| Israel | Novo Nordisk Investigational Site | Haifa | |
| Israel | Novo Nordisk Investigational Site | Haifa | |
| Israel | Novo Nordisk Investigational Site | Jerusalem | |
| Israel | Novo Nordisk Investigational Site | Rishon Le Zion | |
| Israel | Novo Nordisk Investigational Site | Tel Hashomer | |
| Italy | Novo Nordisk Investigational Site | Catanzaro | |
| Italy | Novo Nordisk Investigational Site | Chieti Scalo | |
| Italy | Novo Nordisk Investigational Site | Firenze | |
| Italy | Novo Nordisk Investigational Site | Forlì | |
| Italy | Novo Nordisk Investigational Site | Latina | |
| Italy | Novo Nordisk Investigational Site | Milano | |
| Italy | Novo Nordisk Investigational Site | Padova | |
| Italy | Novo Nordisk Investigational Site | Perugia | |
| Italy | Novo Nordisk Investigational Site | Pistoia | |
| Puerto Rico | Novo Nordisk Investigational Site | San Juan | |
| South Africa | Novo Nordisk Investigational Site | Bloemfontein | Free State |
| South Africa | Novo Nordisk Investigational Site | Brits | North West |
| South Africa | Novo Nordisk Investigational Site | Cape Town | Western Cape |
| South Africa | Novo Nordisk Investigational Site | Cape Town | Western Cape |
| South Africa | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Lenasia | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Port Elizabeth | Eastern Cape |
| South Africa | Novo Nordisk Investigational Site | Pretoria | Gauteng |
| Spain | Novo Nordisk Investigational Site | Granada | |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Spain | Novo Nordisk Investigational Site | Palma de Mallorca | |
| Spain | Novo Nordisk Investigational Site | Partida De Bacarot | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| Sweden | Novo Nordisk Investigational Site | Ängelholm | |
| Sweden | Novo Nordisk Investigational Site | Dalby | |
| Sweden | Novo Nordisk Investigational Site | Göteborg | |
| Sweden | Novo Nordisk Investigational Site | Göteborg | |
| Sweden | Novo Nordisk Investigational Site | Luleå | |
| Sweden | Novo Nordisk Investigational Site | Lund | |
| Sweden | Novo Nordisk Investigational Site | Örebro | |
| Sweden | Novo Nordisk Investigational Site | Stockholm | |
| Sweden | Novo Nordisk Investigational Site | Stockholm | |
| Taiwan | Novo Nordisk Investigational Site | Taichung | |
| Taiwan | Novo Nordisk Investigational Site | Tainan city | |
| Taiwan | Novo Nordisk Investigational Site | Taoyuan | |
| Turkey | Novo Nordisk Investigational Site | Ankara | |
| Turkey | Novo Nordisk Investigational Site | Gaziantep | |
| Turkey | Novo Nordisk Investigational Site | Hatay | |
| Turkey | Novo Nordisk Investigational Site | Istanbul | |
| Turkey | Novo Nordisk Investigational Site | Izmir | |
| Turkey | Novo Nordisk Investigational Site | Kahramanmaras | |
| United Kingdom | Novo Nordisk Investigational Site | Airdrie | |
| United Kingdom | Novo Nordisk Investigational Site | Ayr | |
| United Kingdom | Novo Nordisk Investigational Site | Bexhill-on-Sea | |
| United Kingdom | Novo Nordisk Investigational Site | Birmingham | |
| United Kingdom | Novo Nordisk Investigational Site | Bristol | |
| United Kingdom | Novo Nordisk Investigational Site | Cambridge | |
| United Kingdom | Novo Nordisk Investigational Site | Chester | |
| United Kingdom | Novo Nordisk Investigational Site | Darlington | |
| United Kingdom | Novo Nordisk Investigational Site | Leeds | |
| United Kingdom | Novo Nordisk Investigational Site | Leicester | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | Middlesbrough | |
| United Kingdom | Novo Nordisk Investigational Site | Nottingham | |
| United Kingdom | Novo Nordisk Investigational Site | Plymouth | |
| United Kingdom | Novo Nordisk Investigational Site | Rotherham | |
| United Kingdom | Novo Nordisk Investigational Site | Swansea | |
| United Kingdom | Novo Nordisk Investigational Site | Truro | |
| United States | Novo Nordisk Investigational Site | Albany | New York |
| United States | Novo Nordisk Investigational Site | Anderson | South Carolina |
| United States | Novo Nordisk Investigational Site | Arvada | Colorado |
| United States | Novo Nordisk Investigational Site | Asheville | North Carolina |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Austin | Texas |
| United States | Novo Nordisk Investigational Site | Austin | Texas |
| United States | Novo Nordisk Investigational Site | Bristol | Tennessee |
| United States | Novo Nordisk Investigational Site | Brooksville | Florida |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Clearwater | Florida |
| United States | Novo Nordisk Investigational Site | Columbia | Maryland |
| United States | Novo Nordisk Investigational Site | Columbus | Georgia |
| United States | Novo Nordisk Investigational Site | Concord | California |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dayton | Ohio |
| United States | Novo Nordisk Investigational Site | Endwell | New York |
| United States | Novo Nordisk Investigational Site | Greensboro | North Carolina |
| United States | Novo Nordisk Investigational Site | Hickory | North Carolina |
| United States | Novo Nordisk Investigational Site | Hollywood | Florida |
| United States | Novo Nordisk Investigational Site | Honolulu | Hawaii |
| United States | Novo Nordisk Investigational Site | Hyattsville | Maryland |
| United States | Novo Nordisk Investigational Site | Jonesboro | Arkansas |
| United States | Novo Nordisk Investigational Site | Kissimmee | Florida |
| United States | Novo Nordisk Investigational Site | Lawrenceville | New Jersey |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Long Beach | California |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Louisville | Kentucky |
| United States | Novo Nordisk Investigational Site | Meridian | Idaho |
| United States | Novo Nordisk Investigational Site | Minneapolis | Minnesota |
| United States | Novo Nordisk Investigational Site | Mission Hills | California |
| United States | Novo Nordisk Investigational Site | Moncks Corner | South Carolina |
| United States | Novo Nordisk Investigational Site | Morehead City | North Carolina |
| United States | Novo Nordisk Investigational Site | Nashville | Tennessee |
| United States | Novo Nordisk Investigational Site | New Orleans | Louisiana |
| United States | Novo Nordisk Investigational Site | Newport News | Virginia |
| United States | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma |
| United States | Novo Nordisk Investigational Site | Olympia | Washington |
| United States | Novo Nordisk Investigational Site | Peoria | Arizona |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Plantation | Florida |
| United States | Novo Nordisk Investigational Site | Raleigh | North Carolina |
| United States | Novo Nordisk Investigational Site | Roswell | Georgia |
| United States | Novo Nordisk Investigational Site | Saint George | Utah |
| United States | Novo Nordisk Investigational Site | Saint Louis | Missouri |
| United States | Novo Nordisk Investigational Site | Salisbury | North Carolina |
| United States | Novo Nordisk Investigational Site | Salt Lake City | Utah |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | Southfield | Michigan |
| United States | Novo Nordisk Investigational Site | Spring Valley | California |
| United States | Novo Nordisk Investigational Site | Springfield | Illinois |
| United States | Novo Nordisk Investigational Site | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Toms River | New Jersey |
| United States | Novo Nordisk Investigational Site | Topeka | Kansas |
| United States | Novo Nordisk Investigational Site | Tustin | California |
| United States | Novo Nordisk Investigational Site | Vestavia Hills | Alabama |
| United States | Novo Nordisk Investigational Site | Wilmington | North Carolina |
| United States | Novo Nordisk Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, France, Germany, India, Israel, Italy, Puerto Rico, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom,
Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjøth 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. — View Citation
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 — View Citation
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 — View Citation
Davies MJ, Bergenstal R, Bode B, Kushner RF, Lewin A, Skjøth 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 — View Citation
Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjøth TV, Bjørn 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 Spr — View Citation
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/m²: A Post-hoc Analysis. Obes Facts. 2017 Nov 17;10(6):531-544. doi: 10.1159/000478099. [Epub ahead of print] — View Citation
McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814. Review. — View Citation
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 — View Citation
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 A — View Citation
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. — View Citation
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 Po — View Citation
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. — View Citation
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. — View Citation
* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Secondary | Proportion of Subjects Reaching Target HbA1c Below 7% | at 56 weeks | ||
| Secondary | Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5% | at 56 weeks | ||
| Secondary | Change From Baseline in Waist Circumference | Week 0, week 56 | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Change From Baseline in Waist Circumference | Week 0, week 68 | ||
| Secondary | Change From Week 56 to 68 in Waist Circumference | Week 56, week 68 | ||
| Secondary | 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 |
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