Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01272232Other idNN8022-1922Other id2008-002199-88Other idU1111-1118-7963Other id2008

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 846 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 13 countries
United States, France, Germany, India, Israel, Italy, Puerto Rico, South Africa, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Start: 1 Jun 2011
Primary completion: 1 Jan 2013
Completion: 25 Jan 2013
First posted: 7 Jan 2011 (estimated)
Last update posted: 29 Dec 2017
Conditions: Metabolism and Nutrition Disorder · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2011201220132014

Ph 3
Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
NCT01272232
1 Jun 2011 to 25 Jan 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

liraglutideDrug
liraglutideDrug
placeboDrug

Arms3

Experimental
Lira 3.0 mg
Experimental
Lira 1.8 mg
Experimental
Placebo

Primary outcomes3

Outcomes the sponsor listed as primary.

Change (%) From Baseline in Body Weight (Fasting)
Time frame · Week 0, week 56
Registry description
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
Registry description
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
Registry description
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.

Secondary outcomes(9)

Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)
Time frame · Week 0, week 56
Registry description
Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and 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
Registry description
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.
Change (%) From Week 56 to 68 in Body Weight (Fasting)
Time frame · Week 56, week 68
Registry description
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.
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
Registry description
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 \[56 mg/dL\]).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, week 56

Change (%) From Baseline in Body Weight (Fasting)

Group	Value (percent change)	Spread
Liraglutide 3.0 mg	-5.9	5.5
Liraglutide 1.8 mg	-4.6	5.5
Liraglutide Placebo	-2.0	4.3

Primary outcomeNumber· at 56 weeks

Proportion of Subjects Losing at Least 5% of Baseline Body Weight

Group	Value (percentage of subjects)
Liraglutide 3.0 mg	49.9
Liraglutide 1.8 mg	35.6
Liraglutide Placebo	13.8

Primary outcomeNumber· at 56 weeks

Proportion of Subjects Losing More Than 10% of Baseline Body Weight

Group	Value (percentage of subjects)
Liraglutide 3.0 mg	23.4
Liraglutide 1.8 mg	14.4
Liraglutide Placebo	4.3

Secondary and other outcome results(5)

Secondary outcomeMean· Week 0, week 56

Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)

Group	Value (percentage point change of HbA1c)	Spread
Liraglutide 3.0 mg	-1.3	0.9
Liraglutide 1.8 mg	-1.1	1.0
Liraglutide Placebo	-0.3	0.9

Secondary outcomeNumber· at 56 weeks

Proportion of Subjects Reaching Target HbA1c Below 7%

Group	Value (percentage of subjects)
Liraglutide 3.0 mg	69.2
Liraglutide 1.8 mg	66.7
Liraglutide Placebo	27.2

Secondary outcomeNumber· at 56 weeks

Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%

Group	Value (percentage of subjects)
Liraglutide 3.0 mg	56.5
Liraglutide 1.8 mg	45.6
Liraglutide Placebo	15.0

Secondary outcomeMean· Week 0, week 56

Change From Baseline in Waist Circumference

Group	Value (cm)	Spread
Liraglutide 3.0 mg	-6.1	6.5
Liraglutide 1.8 mg	-4.8	5.6
Liraglutide Placebo	-2.7	5.4

Secondary outcomeMean· Week 0, week 68

Change (%) From Baseline in Body Weight (Fasting)

Group	Value (percent change)	Spread
Liraglutide 3.0 mg	-4.7	5.0
Liraglutide 1.8 mg	-3.6	5.7
Liraglutide Placebo	-2.7	5.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Liraglutide 3.0 mgExposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.	–	37 / 422	361 / 422
Liraglutide 1.8 mgExposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.	–	18 / 210	173 / 210
Liraglutide PlaceboExposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.	–	13 / 212	164 / 212

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies13

Studies that cite this trial.

Studies with results

8 studies on this page

Indexing hint: Meta-analysis (pooled) · 2018

2 results

Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials.

Davies et al. 2018Diabetes, obesity & metabolismcited by 80

PMID 28950422PMC5836948DOI 10.1111/dom.13125PUB-28950422

Free to read · publisher termsCC BY-NC2 results

Read at source See results (2)

Indexing hint: Randomized controlled trial · 2017

5 results

Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials.

von Scholten et al. 2017Journal of diabetes and its complicationscited by 6

PMID 28462892DOI 10.1016/j.jdiacomp.2017.04.003PUB-28462892

Full text at the publisher5 results

Publisher page See results (5)

Indexing hint: Randomized controlled trial · 2017

5 results

Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis.

le Roux et al. 2017Obesity factscited by 28

PMID 29145215PMC5836203DOI 10.1159/000478099PUB-29145215

Free to read · publisher termsCC BY-NC-ND5 results

Read at source See results (5)

Indexing hint: Randomized controlled trial · 2016

7 results

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.

Ard et al. 2016Diabetes, obesity & metabolismcited by 33

PMID 26744025PMC6084344DOI 10.1111/dom.12632PUB-26744025

Free to read · publisher termsCC BY-NC-ND7 results

Read at source See results (7)

Indexing hint: Randomized controlled trial · 2016

5 results

Exposure-response analyses of liraglutide 3.0 mg for weight management.

Wilding et al. 2016Diabetes, obesity & metabolismcited by 74

PMID 26833744PMC5069568DOI 10.1111/dom.12639PUB-26833744

Free to read · publisher termsCC BY-NC-ND5 results

Read at source See results (5)

Indexing hint: Randomized controlled trial · 2016

9 results

Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis.

Overgaard et al. 2016Clinical pharmacokineticscited by 44

PMID 27193270PMC5069304DOI 10.1007/s40262-016-0410-7PUB-27193270

Free to read · publisher termsCC BY-NC9 results

Read at source See results (9)

Indexing hint: Randomized controlled trial · 2016

8 results

EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS.

O'Neil et al. 2016Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 18

PMID 27482610DOI 10.4158/ep151181.orPUB-27482610

Full text at the publisher8 results

Publisher page See results (8)

Indexing hint: Randomized controlled trial · 2016

9 results

Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers.

Fujioka et al. 2016Obesity (Silver Spring, Md.)cited by 101

PMID 27804269PMC5129670DOI 10.1002/oby.21629PUB-27804269

Free to read · publisher termsCC BY-NC-ND9 results

Read at source See results (9)

More studies

5 studies on this page

PubMed tag: none · 2017

Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects.

Bays et al. 2017Current medical research and opinioncited by 38

PMID 27817208DOI 10.1080/03007995.2016.1251892PUB-27817208

Full text at the publisher

Publisher page

PubMed tag: none · 2017

Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials.

O'Neil et al. 2017Diabetes, obesity & metabolismcited by 93

PMID 28386912PMC5655710DOI 10.1111/dom.12963PUB-28386912

Free to read · publisher termsCC BY-NC-ND

Read at source

PubMed tag: none · 2017

Corrected

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.

Steinberg et al. 2017Diabetes carecited by 55

PMID 28473337DOI 10.2337/dc16-2684PUB-28473337

Full text at the publisher

Publisher page Read the notice

Indexing hint: Review · 2016

Missing data in clinical trials for weight management.

McEvoy et al. 2016Journal of biopharmaceutical statisticscited by 23

PMID 26418188DOI 10.1080/10543406.2015.1094814PUB-26418188

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2015

Corrected

Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial.

Davies et al. 2015JAMAcited by 837

PMID 26284720DOI 10.1001/jama.2015.9676PUB-26284720

Full text at the publisher

Publisher page Read the notice

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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