Metabolism and Nutrition DisorderPhase 3NCT01272232

Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes

A Phase 3 study testing liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 161 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metabolism and Nutrition Disorder, Obesity
What is being tested?: liraglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 846 participants
Where: 161 sitesin 13 countries
Study dates: 1 Jun 2011to 25 Jan 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

161 sites in 13 countries.

Country

City, postcode or hospital

161 sites in 13 countries

United States67 sites

Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Anderson, South Carolina, 29621
Novo Nordisk Investigational Site
Arvada, Colorado, 80005
Novo Nordisk Investigational Site
Asheville, North Carolina, 28803
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Austin, Texas, 78728
Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Bristol, Tennessee, 37620
Novo Nordisk Investigational Site
Brooksville, Florida, 34601
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, 60611-5975
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45255
Novo Nordisk Investigational Site
Clearwater, Florida, 33765
Novo Nordisk Investigational Site
Columbia, Maryland, 21045
Novo Nordisk Investigational Site
Columbus, Georgia, 31904
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Endwell, New York, 13760
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Hickory, North Carolina, 28602
Novo Nordisk Investigational Site
Hollywood, Florida, 33021
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96814
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782
Novo Nordisk Investigational Site
Jonesboro, Arkansas, 72401
Novo Nordisk Investigational Site
Kissimmee, Florida, 34741
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Long Beach, California, 90807
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Louisville, Kentucky, 40213
Novo Nordisk Investigational Site
Meridian, Idaho, 83642
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
Mission Hills, California, 91345
Novo Nordisk Investigational Site
Moncks Corner, South Carolina, 29461
Novo Nordisk Investigational Site
Morehead City, North Carolina, 28557
Novo Nordisk Investigational Site
Nashville, Tennessee, 37212
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70121
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73104
Novo Nordisk Investigational Site
Olympia, Washington, 98502
Novo Nordisk Investigational Site
Peoria, Arizona, 85381
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Raleigh, North Carolina, 27609
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Salisbury, North Carolina, 28144
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84102
Novo Nordisk Investigational Site
San Antonio, Texas, 78207-5209
Novo Nordisk Investigational Site
San Antonio, Texas, 78240
Novo Nordisk Investigational Site
San Antonio, Texas, 78258
Novo Nordisk Investigational Site
Southfield, Michigan, 48034-7661
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
Springfield, Illinois, 62711
Novo Nordisk Investigational Site
St Louis, Missouri, 63110
Novo Nordisk Investigational Site
St. George, Utah, 84790
Novo Nordisk Investigational Site
Tampa, Florida, 33603
Novo Nordisk Investigational Site
Toms River, New Jersey, 08755-8050
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, 35209
Novo Nordisk Investigational Site
Wilmington, North Carolina, 28401
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

United Kingdom17 sites

Novo Nordisk Investigational Site
Airdrie, ML6 0JS
Novo Nordisk Investigational Site
Ayr, KA6 6DX
Novo Nordisk Investigational Site
Bexhill-on-Sea, TN39 4SP
Novo Nordisk Investigational Site
Birmingham, B9 5SS
Novo Nordisk Investigational Site
Bristol, BS10 5NB
Novo Nordisk Investigational Site
Cambridge, CB2 2QQ
Novo Nordisk Investigational Site
Chester, CH2 1UL
Novo Nordisk Investigational Site
Darlington, DL2 1AA
Novo Nordisk Investigational Site
Leeds, LS25 1AN
Novo Nordisk Investigational Site
Leicester, LE5 4PW
Novo Nordisk Investigational Site
London, E1 2EF
Novo Nordisk Investigational Site
Middlesbrough, TS4 3BW
Novo Nordisk Investigational Site
Nottingham, NG7 2UH
Novo Nordisk Investigational Site
Plymouth, PL6 8BQ
Novo Nordisk Investigational Site
Rotherham, S651DA
Novo Nordisk Investigational Site
Swansea, SA6 6NL
Novo Nordisk Investigational Site
Truro, TR1 3LJ

Other trials in United Kingdom

Germany13 sites

Novo Nordisk Investigational Site
Berlin, 12157
Novo Nordisk Investigational Site
Berlin, 12163
Novo Nordisk Investigational Site
Berlin, 12203
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Dresden, 01309
Novo Nordisk Investigational Site
Gebhardshain, 57580
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Heidelberg, 69120
Novo Nordisk Investigational Site
Hohenmölsen, 06679
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Schkeuditz, 04435
Novo Nordisk Investigational Site
Stuttgart, 70378
Novo Nordisk Investigational Site
Wangen, 88239

Other trials in Germany

Italy9 sites

Novo Nordisk Investigational Site
Catanzaro, 88100
Novo Nordisk Investigational Site
Chieti Scalo, 66100
Novo Nordisk Investigational Site
Florence, 50141
Novo Nordisk Investigational Site
Forlì, 47100
Novo Nordisk Investigational Site
Latina, 04100
Novo Nordisk Investigational Site
Milan, 20132
Novo Nordisk Investigational Site
Padova, 35143
Novo Nordisk Investigational Site
Perugia, 06126
Novo Nordisk Investigational Site
Pistoia, 51100

Other trials in Italy

South Africa9 sites

Novo Nordisk Investigational Site
Bloemfontein, Free State, 9301
Novo Nordisk Investigational Site
Brits, North West, 0250
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7460
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7708
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4001
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2194
Novo Nordisk Investigational Site
Lenasia, Gauteng, 1827
Novo Nordisk Investigational Site
Port Elizabeth, Eastern Cape, 6045
Novo Nordisk Investigational Site
Pretoria, Gauteng, 0001

Other trials in South Africa

Sweden9 sites

Novo Nordisk Investigational Site
Ängelholm, 262 81
Novo Nordisk Investigational Site
Dalby, 240 10
Novo Nordisk Investigational Site
Gothenburg, 416 65
Novo Nordisk Investigational Site
Gothenburg, 417 17
Novo Nordisk Investigational Site
Luleå, 972 33
Novo Nordisk Investigational Site
Lund, 221 85
Novo Nordisk Investigational Site
Örebro, 701 85
Novo Nordisk Investigational Site
Stockholm, 112 81
Novo Nordisk Investigational Site
Stockholm, 141 86

Other trials in Sweden

France8 sites

Novo Nordisk Investigational Site
Bondy, 93143
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Nanterre, 92014
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Pointe à Pitre, 97139
Novo Nordisk Investigational Site
Saint-Herblain, 44800
Novo Nordisk Investigational Site
Vénissieux, 69200

Other trials in France

Spain8 sites

Novo Nordisk Investigational Site
Granada, 18012
Novo Nordisk Investigational Site
Madrid, 28007
Novo Nordisk Investigational Site
Madrid, 28034
Novo Nordisk Investigational Site
Palma de Mallorca, 07010
Novo Nordisk Investigational Site
Partida de Bacarot, 03114
Novo Nordisk Investigational Site
Seville, 41009
Novo Nordisk Investigational Site
Seville, 41010
Novo Nordisk Investigational Site
Seville, 41014

Other trials in Spain

Israel6 sites

Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Haifa, 31096
Novo Nordisk Investigational Site
Haifa, 35152
Novo Nordisk Investigational Site
Jerusalem, 91120
Novo Nordisk Investigational Site
Rishon LeZiyyon, 75650
Novo Nordisk Investigational Site
Tel HaShomer, 52621

Other trials in Israel

Turkey (Türkiye)6 sites

Novo Nordisk Investigational Site
Ankara, 06100
Novo Nordisk Investigational Site
Gaziantep, 27070
Novo Nordisk Investigational Site
Hatay, 31040
Novo Nordisk Investigational Site
Istanbul, 34096
Novo Nordisk Investigational Site
Izmir, 35340
Novo Nordisk Investigational Site
Kahramanmaraş, 46000

Other trials in Turkey (Türkiye)

India5 sites

Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600086
Novo Nordisk Investigational Site
Jaipur, Rajasthan, 302006
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700020
Novo Nordisk Investigational Site
Pune, 411011
Novo Nordisk Investigational Site
Thriruvananthapuram, 695 032

Other trials in India

Taiwan3 sites

Novo Nordisk Investigational Site
Taichung, 404
Novo Nordisk Investigational Site
Tainan, 710
Novo Nordisk Investigational Site
Taoyuan, 333

Other trials in Taiwan

Puerto Rico1 site

Novo Nordisk Investigational Site
San Juan, 00921

Other trials in Puerto Rico

About this study

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

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.

Conditions: Metabolism and Nutrition Disorder, Obesity
Being tested: liraglutide, placebo
Medical subject headings: Nutrition Disorders, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liraglutideDrug
Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
liraglutideDrug
Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
placeboDrug
Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

Study groups in NCT01272232
Study group	Role	What they receive
Lira 3.0 mg	Experimental	Not described Receives: Drug: liraglutide
Lira 1.8 mg	Experimental	Not described Receives: Drug: liraglutide
Placebo	Experimental	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: at 56 weeks

Secondary outcomes (9)

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.
Measured: Week 0, week 56
Proportion of Subjects Reaching Target HbA1c Below 7%
Measured: at 56 weeks
Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%
Measured: at 56 weeks
Change From Baseline in Waist Circumference
Measured: 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.
Measured: 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.
Measured: Week 56, week 68
Change From Baseline in Waist Circumference
Measured: Week 0, week 68
Change From Week 56 to 68 in Waist Circumference
Measured: 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]).
Measured: Weeks 0-56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201125 Jan 2013

First posted7 Jan 2011 (estimated)
Study start1 Jun 2011
Primary completion1 Jan 2013
Study completion25 Jan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Metabolism and Nutrition DisorderStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 846 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01272232
Sponsor's protocol ID: NN8022-1922
Other IDs: 2008-002199-88, U1111-1118-7963, 2008
Status last verified: Dec 2017
First submitted: 6 Jan 2011
Last updated: 29 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29145215
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.
PubMed 27193270
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.
PubMed 27482610
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.
PubMed 27804269
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.
PubMed 27817208
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.
PubMed 26744025
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.
PubMed 26833744
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.
PubMed 26284720
McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.
PubMed 26418188
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.
PubMed 28473337
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.
PubMed 28462892
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.
PubMed 28386912
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.
PubMed 28950422

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01272232
Acronym / sponsor ID: NN8022-1922
Conditions: Metabolism and Nutrition Disorder, Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 846 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 1 Jun 2011 (actual)
Primary completion: 1 Jan 2013 (actual)
Study completion: 25 Jan 2013 (actual)
First posted: 7 Jan 2011 (estimated)
Results: Posted 9 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Lira 3.0 mg	Experimental	Drug: liraglutide
Lira 1.8 mg	Experimental	Drug: liraglutide
Placebo	Experimental	Drug: placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liraglutideLiraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.	Drug	Lira 3.0 mg
liraglutideLiraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.	Drug	Lira 1.8 mg
placeboLiraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.	Drug	Placebo

Primary outcome

Change (%) From Baseline in Body Weight (Fasting)
Time frame: Week 0, week 56
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.
Proportion of Subjects Losing at Least 5% of Baseline Body Weight
Time frame: at 56 weeks
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.
Proportion of Subjects Losing More Than 10% of Baseline Body Weight
Time frame: at 56 weeks
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.

9 secondary outcomes

Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)
Time frame: Week 0, week 56
Proportion of Subjects Reaching Target HbA1c Below 7%
Time frame: at 56 weeks
Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%
Time frame: at 56 weeks
Change From Baseline in Waist Circumference
Time frame: Week 0, week 56
Change (%) From Baseline in Body Weight (Fasting)
Time frame: Week 0, week 68
Change (%) From Week 56 to 68 in Body Weight (Fasting)
Time frame: Week 56, week 68
Change From Baseline in Waist Circumference
Time frame: Week 0, week 68
Change From Week 56 to 68 in Waist Circumference
Time frame: Week 56, week 68
Incidence of Hypoglycaemic Episodes
Time frame: Weeks 0-56

Results and safety

Results posted to the registry on 9 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liraglutide 3.0 mg	423	324
Liraglutide 1.8 mg	211	164
Liraglutide Placebo	212	140

Primary outcome: Change (%) From Baseline in Body Weight (Fasting)

Time frame: Week 0, week 56. Mean (Standard Deviation). Unit: percent change

Measure	Liraglutide 3.0 mg n = 412	Liraglutide 1.8 mg n = 204	Liraglutide Placebo n = 211
Value	-5.9 (5.5)	-4.6 (5.5)	-2.0 (4.3)

Liraglutide 3.0 mg vs Liraglutide Placebo: Treatment contrast: -3.97 (95% CI -4.84 to -3.11), p <0.0001, ANCOVA
Liraglutide 1.8 mg vs Liraglutide Placebo: Treatment contrast: -2.62 (95% CI -3.63 to -1.62), p <0.0001, ANCOVA
Liraglutide 3.0 mg vs Liraglutide 1.8 mg: Treatment contrast: -1.35 (95% CI -2.23 to -0.48), p = 0.0024, ANCOVA

Population analysed: Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.

Primary outcome: Proportion of Subjects Losing at Least 5% of Baseline Body Weight

Time frame: at 56 weeks. Number. Unit: percentage of subjects

Measure	Liraglutide 3.0 mg n = 412	Liraglutide 1.8 mg n = 204	Liraglutide Placebo n = 211
Yes	49.9	35.6	13.8
No	50.1	64.4	86.2

Liraglutide 3.0 mg vs Liraglutide Placebo: Odds Ratio (OR): 6.81 (95% CI 4.34 to 10.68), p <0.0001, Regression, Logistic
Liraglutide 1.8 mg vs Liraglutide Placebo: Odds Ratio (OR): 3.69 (95% CI 2.24 to 6.09), p <0.0001, Regression, Logistic
Liraglutide 3.0 mg vs Liraglutide 1.8 mg: Odds Ratio (OR): 1.84 (95% CI 1.29 to 2.64), p = 0.0008, Regression, Logistic

Primary outcome: Proportion of Subjects Losing More Than 10% of Baseline Body Weight

Time frame: at 56 weeks. Number. Unit: percentage of subjects

Measure	Liraglutide 3.0 mg n = 412	Liraglutide 1.8 mg n = 204	Liraglutide Placebo n = 211
Yes	23.4	14.4	4.3
No	76.6	85.6	95.7

Liraglutide 3.0 mg vs Liraglutide Placebo: Odds Ratio (OR): 7.10 (95% CI 3.48 to 14.48), p <0.0001, Regression, Logistic
Liraglutide 1.8 mg vs Liraglutide Placebo: Odds Ratio (OR): 3.84 (95% CI 1.75 to 8.41), p = 0.0008, Regression, Logistic
Liraglutide 3.0 mg vs Liraglutide 1.8 mg: Odds Ratio (OR): 1.85 (95% CI 1.16 to 2.95), p = 0.0099, Regression, Logistic

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded for up to 68 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide 3.0 mg	37 of 422 (8.8%)	361 of 422 (85.5%)	Not reported
Liraglutide 1.8 mg	18 of 210 (8.6%)	173 of 210 (82.4%)	Not reported
Liraglutide Placebo	13 of 212 (6.1%)	164 of 212 (77.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29145215le 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.
Results publication: PubMed 27193270Overgaard 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.
Results publication: PubMed 27482610O'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.
Results publication: PubMed 27804269Fujioka 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.
Results publication: PubMed 27817208Bays 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.
Results publication: PubMed 26744025Ard 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.
Results publication: PubMed 26833744Wilding 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.
Results publication: PubMed 26284720Davies 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.
Results publication: PubMed 26418188McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.
Results publication: PubMed 28473337Steinberg 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.
Results publication: PubMed 28462892von 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.
Results publication: PubMed 28386912O'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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

161 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 161 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in United States, United Kingdom, Germany, Italy, South Africa and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change (%) From Baseline in Body Weight (Fasting) (time frame: Week 0, week 56). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01272232, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.