SCALE™ Insulin

CompletedPhase 3Results posted

Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

396

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 6-10%

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02963922

Org study IDNN8022-4272

Secondary ID2015-005619-33

Secondary IDU1111-1177-4903World Health Organization (WHO)

Timeline

Milestones

Study first posted2016-11-15estimated

Study start2017-02-06actual

Primary completion2018-09-10actual

Study completion2018-09-25actual

Results first posted2019-11-27actual

Last update posted2020-03-30actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Diagnosed with type 2 diabetes mellitus - Treatment with up to 2 OADs (oral anti-diabetic) (metformin, glitazone, SGLT-2 inhibitor (sodium-glucose cotransporter-2 inhibitors) or sulphonylurea) - Stable treatment with basal insulin according to its label (no requirement of minimum or maximum dose) for at least 90 days prior to screening, as judged by the investigator - HbA1c (glycosylated haemoglobin) 6.0-10.0% (both inclusive) - BMI (body mass index) equal to or above 27 kg/m^2 - Age at least 18 years at the time of signing informed consent Exclusion Criteria: - Diagnosis of type 1 diabetes - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8 (see Section 8.2.3) - Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator - Unable or unwilling to perform self-monitoring of plasma glucose according to the protocol and to keep a diabetes diary - Treatment with any hypoglycaemic medications other than OADs and basal insulin within the past 90 days prior to screening - Treatment with a DPP-IV (dipeptidyl peptidase-4) inhibitor within the past 90 days prior to screening - Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block - Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2) - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) - For Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner - Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics) - History of pancreatitis (acute or chronic) - History of major depressive disorder within the past 2 years - Any lifetime history of a suicide attempt - Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to110 mmHg). - History of malignancy (except for non-melanoma skin cancer) within the past 5 years

Endpoints (92)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Patient-reported / QoL

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

Renal / kidney

Weight & body composition

8 endpoints

Primary/registry result

Change in Body Weight (%)

Time frame:Week 0, week 56

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Liraglutide 3.0 mgIn-trial observation period	-6.0	—
On-drug observation period	-6.5	—
PlaceboIn-trial observation period	-1.5	—
On-drug observation period	-1.7	—

Treatment difference-4.3295% CI-5.48 – -3.16p< .0001ANCOVA

Treatment difference-5.1095% CI-6.30 – -3.91p< .0001MMRM

Primary/registry result

Participants Losing at Least 5% of Baseline Body Weight

Time frame:Week 56

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mgIn-trial observation period	51.80	—
On-drug observation period	56.92	—
PlaceboIn-trial observation period	23.98	—
On-drug observation period	21.83	—

Odds Ratio (OR)3.4195% CI2.19 – 5.31p<.0001Regression, Logistic

Odds Ratio (OR)4.7395% CI3.04 – 7.36p<.0001Mixed model for repeated measurements

Primary/protocol endpoint

Change in Body Weight (%)

Time frame:Week 0, week 56

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Participants Losing at Least 5% of Baseline Body Weight

Time frame:Week 56

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Participants Losing More Than 10% of Baseline Body Weight at Week 56

Time frame:Week 56

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mgIn-trial observation period	22.77	—
On-drug observation period	22.56	—
PlaceboIn-trial observation period	6.55	—
On-drug observation period	5.58	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 56

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeters (cm)	95% CI
Liraglutide 3.0 mgIn-trial observation period	-5.40	—
On-drug observation period	-5.71	—
PlaceboIn-trial observation period	-2.60	—
On-drug observation period	-2.78	—

Secondary/protocol endpoint

Participants Losing More Than 10% of Baseline Body Weight at Week 56

Time frame:Week 56

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, week 56

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

18 endpoints

Secondary/registry result

Change in HbA1c

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Liraglutide 3.0 mgIn-trial observation period	-1.1	—
On-drug observation period	-1.2	—
PlaceboIn-trial observation period	-0.5	—
On-drug observation period	-0.7	—

Secondary/registry result

Change in FPG

Time frame:Week 0, week 56

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Liraglutide 3.0 mgIn-trial observation period	-0.91	—
On-drug observation period	-1.05	—
PlaceboIn-trial observation period	-0.68	—
On-drug observation period	-0.96	—

Secondary/registry result

Change in Total Daily Insulin Dose (U)

Time frame:Week 0, week 56

change from baseline, improvement

Posted result

Group	Value (mean), Units of insulin dose (U)	95% CI
Liraglutide 3.0 mg	3	—
Placebo	18	—

Secondary/registry result/low confidence

Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U)

Time frame:Week 0, week 56

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Liraglutide 3.0 mg	19	—
Placebo	64	—

Secondary/registry result

Change in Total Daily Basal Insulin Dose (U/kg)

Time frame:Week 0, week 56

change from baseline, improvement

Posted result

Group	Value (mean), Units of insulin dose per kilogram(U/kg)	95% CI
Liraglutide 3.0 mg	0.05	—
Placebo	0.15	—

Secondary/registry result

Change in Total Daily Insulin Dose (U/kg)

Time frame:Week 0, week 56

change from baseline, improvement

Posted result

Group	Value (mean), U/kg	95% CI
Liraglutide 3.0 mg	0.05	—
Placebo	0.18	—

Secondary/registry result

Change in 7-point SMPG Profile Mean Daytime Glucose Value

Time frame:Week 0, week 56

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mg	-2.2	—
Placebo	-1.6	—

Secondary/registry result

Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5%

Time frame:Week 56

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mg	39.9	—
Placebo	13.6	—

Secondary/registry result

Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia

Time frame:Week 56

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders, Documented hypoglycemia

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mg	10.1	—
Placebo	3.5	—

Secondary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:Week 0, week 56

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Total Daily Insulin Dose (U)

Time frame:Week 0, week 56

change from baseline, improvement

Secondary/protocol endpoint

Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U)

Time frame:Week 0, week 56

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Total Daily Basal Insulin Dose (U/kg)

Time frame:Week 0, week 56

change from baseline, improvement

Secondary/protocol endpoint

Change in Total Daily Insulin Dose (U/kg)

Time frame:Week 0, week 56

change from baseline, improvement

Secondary/protocol endpoint

Change in 7-point SMPG Profile Mean Daytime Glucose Value

Time frame:Week 0, week 56

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5%

Time frame:Week 56

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia

Time frame:Week 56

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders, Documented hypoglycemia

Renal / kidney

3 endpoints

Secondary/registry result/low confidence

Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea

Time frame:Week 0, week 56

change from baseline, descriptive

componentsbicarbonate, total calcium, potassium, sodium, urea

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mgBicarbonate serum	0	—
Total Calcium	-0.00	—
Potassium	-0.0	—
Sodium	-1	—
Urea	0.1	—
PlaceboBicarbonate serum	-0	—
Total Calcium	-0.02	—
Potassium	-0.0	—
Sodium	-0	—
Urea	0.1	—

Secondary/registry result

Change in Laboratory Parameters (Biochemistry) - eGFR

Time frame:Week 0, week 56

eGFR, change

change from baseline, improvement

LOINC 98979-8

Posted result

Group	Value (mean), Milliliters per minute per 1.73m^2	95% CI
Liraglutide 3.0 mg	0	—
Placebo	1	—

Secondary/protocol endpoint

Change in Laboratory Parameters (Biochemistry) - eGFR

Time frame:Week 0, week 56

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

10 endpoints

Secondary/registry result

Change in sBP and dBP

Time frame:Week 0, week 56

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Liraglutide 3.0 mgsBP	-6	—
dBP	-3	—
PlacebosBP	-2	—
dBP	-1	—

Secondary/registry result

Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA

Time frame:Week 0, week 56

change from baseline, improvement

componentsTotal cholesterol, change, HDL-C, change, LDL-C, change, VLDL, change, Triglycerides, change, Free fatty acids, change

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mgTotal cholesterol	-0.12	—
HDL cholesterol	0.05	—
LDL cholesterol	-0.08	—
VLDL cholesterol	-0.09	—
Triglycerides	-0.21	—
Free fatty acids	-0.10	—
PlaceboTotal cholesterol	0.04	—
HDL cholesterol	0.03	—
LDL cholesterol	0.05	—
VLDL cholesterol	-0.04	—
Triglycerides	-0.08	—
Free fatty acids	-0.06	—

Secondary/registry result

Change in Resting Pulse

Time frame:Week -1, week 56

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats/minute	95% CI
Liraglutide 3.0 mg	2	—
Placebo	-0	—

Secondary/registry result

Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein

Time frame:Week 0, week 56

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (mean), Milligrams per liter (mg/L)	95% CI
Liraglutide 3.0 mg	-1.40	—
Placebo	-1.29	—

Secondary/registry result

Change in Laboratory Parameters (Biochemistry) - Uric Acid

Time frame:Week 0, week 56

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide 3.0 mg	-0.2	—
Placebo	-0.0	—

Secondary/protocol endpoint

Change in sBP and dBP

Time frame:Week 0, week 56

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA

Time frame:Week 0, week 56

change from baseline, improvement

Secondary/protocol endpoint

Change in Resting Pulse

Time frame:Week -1, week 56

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein

Time frame:Week 0, week 56

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Laboratory Parameters (Biochemistry) - Uric Acid

Time frame:Week 0, week 56

change from baseline, improvement

Patient-reported / QoL

26 endpoints

Secondary/registry result

Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score

Time frame:Week 0, week 56

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mgIn-trial observation period	2.5	—
On-drug observation period	2.9	—
PlaceboIn-trial observation period	2.6	—
On-drug observation period	2.5	—

Secondary/registry result

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score

Time frame:Week 0, week 56

IWQOL-Lite physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mgIn-trial observation period	7.3	—
On-drug observation period	8.2	—
PlaceboIn-trial observation period	6.8	—
On-drug observation period	6.5	—

Secondary/registry result

Change in SF-36: Sub-domains

Time frame:Week 0, week 56

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mgBodily Pain	1.2	—
General Health	1.9	—
Physical Functioning	2.5	—
Role-physical	0.8	—
Role Lim Emotion Prob	-1.2	—
Mental Health	-1.1	—
Social Functioning	-0.7	—
Vitality	1.0	—
PlaceboBodily Pain	1.2	—
General Health	0.3	—
Physical Functioning	2.6	—
Role-physical	0.9	—
Role Lim Emotion Prob	-0.3	—
Mental Health	-1.1	—
Social Functioning	-0.6	—
Vitality	-0.0	—

Secondary/registry result

Change in SF-36: Physical Component Summary (PCS)

Time frame:Week 0, week 56

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mg	2.7	—
Placebo	2.2	—

Secondary/registry result

Change in SF-36: Mental Component Summary (MCS)

Time frame:Week 0, week 56

SF-36 mental

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mg	-1.9	—
Placebo	-1.7	—

Secondary/registry result

Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score

Time frame:Week 0, week 56

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mg	4.0	—
Placebo	4.6	—

Secondary/registry result

Change in IWQoL-Lite for CT: Psychosocial Domain Score

Time frame:Week 0, week 56

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mg	5.4	—
Placebo	4.0	—

Secondary/registry result

Change in IWQoL-Lite for CT: Total Score

Time frame:Week 0, week 56

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mg	5.7	—
Placebo	4.8	—

Secondary/registry result

Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses

Time frame:Week 0, week 56

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 3.0 mgWeek 0: Joint pain	11	—
Week 0: Joint pain	74	—
Week 0: Joint pain	17	—
Week 0: Joint pain	47	—
Week 0: Joint pain	49	—
Week 56: Joint pain	6	—
Week 56: Joint pain	95	—
Week 56: Joint pain	12	—
Week 56: Joint pain	35	—
Week 56: Joint pain	39	—
Week 0: Shortness of breath	0	—
Week 0: Shortness of breath	131	—
Week 0: Shortness of breath	3	—
Week 0: Shortness of breath	45	—
Week 0: Shortness of breath	19	—
Week 56: Shortness of breath	1	—
Week 56: Shortness of breath	137	—
Week 56: Shortness of breath	5	—
Week 56: Shortness of breath	28	—
Week 56: Shortness of breath	16	—
Week 0: Heat sensitivity	8	—
Week 0: Heat sensitivity	106	—
Week 0: Heat sensitivity	13	—
Week 0: Heat sensitivity	34	—
Week 0: Heat sensitivity	37	—
Week 56: Heat sensitivity	2	—
Week 56: Heat sensitivity	92	—
Week 56: Heat sensitivity	12	—
Week 56: Heat sensitivity	42	—
Week 56: Heat sensitivity	39	—
Week 0: Sexual desire	8	—
Week 0: Sexual desire	119	—
Week 0: Sexual desire	13	—
Week 0: Sexual desire	35	—
Week 0: Sexual desire	23	—
Week 56: Sexual desire	6	—
Week 56: Sexual desire	105	—
Week 56: Sexual desire	18	—
Week 56: Sexual desire	34	—
Week 56: Sexual desire	24	—
Week 0: Heavy sweating	2	—
Week 0: Heavy sweating	101	—
Week 0: Heavy sweating	15	—
Week 0: Heavy sweating	40	—
Week 0: Heavy sweating	40	—
Week 56: Heavy sweating	1	—
Week 56: Heavy sweating	98	—
Week 56: Heavy sweating	7	—
Week 56: Heavy sweating	51	—
Week 56: Heavy sweating	30	—
Week 0: Low physical stamina	2	—
Week 0: Low physical stamina	73	—
Week 0: Low physical stamina	22	—
Week 0: Low physical stamina	56	—
Week 0: Low physical stamina	45	—
Week 56: Low physical stamina	3	—
Week 56: Low physical stamina	77	—
Week 56: Low physical stamina	15	—
Week 56: Low physical stamina	57	—
Week 56: Low physical stamina	35	—
Week 0: Foot pain	5	—
Week 0: Foot pain	114	—
Week 0: Foot pain	17	—
Week 0: Foot pain	34	—
Week 0: Foot pain	28	—
Week 56: Foot pain	2	—
Week 56: Foot pain	106	—
Week 56: Foot pain	15	—
Week 56: Foot pain	29	—
Week 56: Foot pain	35	—
Week 0: Trouble sleeping	6	—
Week 0: Trouble sleeping	119	—
Week 0: Trouble sleeping	11	—
Week 0: Trouble sleeping	30	—
Week 0: Trouble sleeping	32	—
Week 56: Trouble sleeping	6	—
Week 56: Trouble sleeping	104	—
Week 56: Trouble sleeping	15	—
Week 56: Trouble sleeping	38	—
Week 56: Trouble sleeping	24	—
Week 0: Back pain	8	—
Week 0: Back pain	96	—
Week 0: Back pain	13	—
Week 0: Back pain	49	—
Week 0: Back pain	32	—
Week 56: Back pain	5	—
Week 56: Back pain	93	—
Week 56: Back pain	13	—
Week 56: Back pain	47	—
Week 56: Back pain	29	—
Week 0: Low energy	0	—
Week 0: Low energy	102	—
Week 0: Low energy	19	—
Week 0: Low energy	46	—
Week 0: Low energy	31	—
Week 56: Low energy	0	—
Week 56: Low energy	82	—
Week 56: Low energy	16	—
Week 56: Low energy	49	—
Week 56: Low energy	40	—
PlaceboWeek 0: Joint pain	5	—
Week 0: Joint pain	85	—
Week 0: Joint pain	18	—
Week 0: Joint pain	42	—
Week 0: Joint pain	46	—
Week 56: Joint pain	5	—
Week 56: Joint pain	75	—
Week 56: Joint pain	17	—
Week 56: Joint pain	39	—
Week 56: Joint pain	52	—
Week 0: Shortness of breath	0	—
Week 0: Shortness of breath	140	—
Week 0: Shortness of breath	3	—
Week 0: Shortness of breath	32	—
Week 0: Shortness of breath	21	—
Week 56: Shortness of breath	1	—
Week 56: Shortness of breath	111	—
Week 56: Shortness of breath	3	—
Week 56: Shortness of breath	46	—
Week 56: Shortness of breath	27	—
Week 0: Heat sensitivity	9	—
Week 0: Heat sensitivity	109	—
Week 0: Heat sensitivity	16	—
Week 0: Heat sensitivity	31	—
Week 0: Heat sensitivity	31	—
Week 56: Heat sensitivity	8	—
Week 56: Heat sensitivity	87	—
Week 56: Heat sensitivity	13	—
Week 56: Heat sensitivity	47	—
Week 56: Heat sensitivity	33	—
Week 0: Sexual desire	8	—
Week 0: Sexual desire	121	—
Week 0: Sexual desire	13	—
Week 0: Sexual desire	32	—
Week 0: Sexual desire	22	—
Week 56: Sexual desire	11	—
Week 56: Sexual desire	109	—
Week 56: Sexual desire	11	—
Week 56: Sexual desire	32	—
Week 56: Sexual desire	25	—
Week 0: Heavy sweating	5	—
Week 0: Heavy sweating	104	—
Week 0: Heavy sweating	14	—
Week 0: Heavy sweating	38	—
Week 0: Heavy sweating	35	—
Week 56: Heavy sweating	5	—
Week 56: Heavy sweating	92	—
Week 56: Heavy sweating	16	—
Week 56: Heavy sweating	48	—
Week 56: Heavy sweating	27	—
Week 0: Low physical stamina	8	—
Week 0: Low physical stamina	78	—
Week 0: Low physical stamina	14	—
Week 0: Low physical stamina	47	—
Week 0: Low physical stamina	49	—
Week 56: Low physical stamina	4	—
Week 56: Low physical stamina	65	—
Week 56: Low physical stamina	19	—
Week 56: Low physical stamina	56	—
Week 56: Low physical stamina	44	—
Week 0: Foot pain	7	—
Week 0: Foot pain	108	—
Week 0: Foot pain	12	—
Week 0: Foot pain	31	—
Week 0: Foot pain	38	—
Week 56: Foot pain	7	—
Week 56: Foot pain	88	—
Week 56: Foot pain	14	—
Week 56: Foot pain	39	—
Week 56: Foot pain	40	—
Week 0: Trouble sleeping	4	—
Week 0: Trouble sleeping	111	—
Week 0: Trouble sleeping	10	—
Week 0: Trouble sleeping	42	—
Week 0: Trouble sleeping	29	—
Week 56: Trouble sleeping	3	—
Week 56: Trouble sleeping	98	—
Week 56: Trouble sleeping	14	—
Week 56: Trouble sleeping	33	—
Week 56: Trouble sleeping	40	—
Week 0: Back pain	6	—
Week 0: Back pain	98	—
Week 0: Back pain	8	—
Week 0: Back pain	40	—
Week 0: Back pain	44	—
Week 56: Back pain	4	—
Week 56: Back pain	86	—
Week 56: Back pain	11	—
Week 56: Back pain	45	—
Week 56: Back pain	42	—
Week 0: Low energy	2	—
Week 0: Low energy	90	—
Week 0: Low energy	12	—
Week 0: Low energy	42	—
Week 0: Low energy	50	—
Week 56: Low energy	4	—
Week 56: Low energy	77	—
Week 56: Low energy	16	—
Week 56: Low energy	50	—
Week 56: Low energy	41	—

Secondary/registry result

Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score

Time frame:Week 56

SF-36 physical

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mg	28.8	—
Placebo	26.3	—

Secondary/registry result

Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS

Time frame:Week 56

SF-36 physical

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mg	37.9	—
Placebo	31.3	—

Secondary/registry result

Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS

Time frame:Week 56

SF-36 mental

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mg	14.6	—
Placebo	11.6	—

Secondary/registry result

Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score

Time frame:Week 56

IWQOL-Lite physical

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mg	25.3	—
Placebo	24.2	—

Secondary/protocol endpoint

Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score

Time frame:Week 0, week 56

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score

Time frame:Week 0, week 56

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: Sub-domains

Time frame:Week 0, week 56

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: Physical Component Summary (PCS)

Time frame:Week 0, week 56

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: Mental Component Summary (MCS)

Time frame:Week 0, week 56

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score

Time frame:Week 0, week 56

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQoL-Lite for CT: Psychosocial Domain Score

Time frame:Week 0, week 56

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQoL-Lite for CT: Total Score

Time frame:Week 0, week 56

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses

Time frame:Week 0, week 56

categorical status, descriptive

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score

Time frame:Week 56

SF-36 physical

threshold achievement, improvement

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS

Time frame:Week 56

SF-36 physical

threshold achievement, improvement

Secondary/protocol endpoint

Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS

Time frame:Week 56

SF-36 mental

threshold achievement, improvement

Secondary/protocol endpoint

Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score

Time frame:Week 56

IWQOL-Lite physical

threshold achievement, improvement

Safety / tolerability / PK

27 endpoints

Secondary/registry result

Adverse Events (AEs)

Time frame:Week 0 to week 56 + 30 days

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Adverse events	95% CI
Liraglutide 3.0 mg	1223	—
Placebo	1148	—

Secondary/registry result

Number of Hypoglycaemic Episodes

Time frame:Week 0 to week 56 + 30 days

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Hypoglycaemic episodes	95% CI
Liraglutide 3.0 mg	1538	—
Placebo	1973	—

Secondary/registry result

Change in Physical Examination

Time frame:Week -1, week 56

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 3.0 mgAbdomen (week -1) Normal	165	—
Abdomen (week -1) Abnormal, NCS	25	—
Abdomen (week -1) Abnormal CS	5	—
Abdomen (week 56) Normal	167	—
Abdomen (week 56) Abnormal, NCS	15	—
Abdomen (week 56) Abnormal, CS	3	—
Gastrointestinal System (week -1) Normal	185	—
Gastrointestinal System (week -1) Abnormal NCS	10	—
Gastrointestinal System (week -1) Abnormal CS	0	—
Gastrointestinal System (week 56) Normal	175	—
Gastrointestinal System (week 56) Abnormal NCS	10	—
Gastrointestinal System (week 56) Abnormal CS	0	—
Cardiovascular System (week-1) Normal	183	—
Cardiovascular System (week-1) Abnormal NCS	10	—
Cardiovascular System (week-1) Abnormal CS	2	—
Cardiovascular System (week 56) Normal	178	—
Cardiovascular System (week 56) Abnormal NCS	6	—
Cardiovascular System (week 56) Abnormal CS	1	—
Nervous System (week -1) Normal	158	—
Nervous System (week -1) Abnormal NCS	26	—
Nervous System (week -1) Abnormal CS	11	—
Nervous System (week 56) Normal	150	—
Nervous System (week 56) Abnormal NCS	22	—
Nervous System (week 56) Abnormal CS	13	—
General Appearance (week -1) Normal	150	—
General Appearance (week -1) Abnormal NCS	39	—
General Appearance (week -1) Abnormal CS	6	—
General Appearance (week 56) Normal	156	—
General Appearance (week 56) Abnormal NCS	23	—
General Appearance (week 56) Abnormal CS	6	—
Head, eyes, ENTand Neck (week -1) Normal	176	—
Head, eyes, ENTand Neck (week -1) Abnormal NCS	17	—
Head, eyes, ENTand Neck (week -1) Abnormal CS	2	—
Head, eyes, ENTand Neck (week 56) Normal	168	—
Head, eyes, ENTand Neck (week 56) Abnormal NCS	15	—
Head, eyes, ENTand Neck (week 56) Abnormal CS	2	—
Lymph Node Palpation (week -1) Normal	195	—
Lymph Node Palpation (week -1) Abnormal NCS	0	—
Lymph Node Palpation (week -1) Abnormal CS	0	—
Lymph Node Palpation (week 56) Normal	185	—
Lymph Node Palpation (week 56) Abnormal NCS	0	—
Lymph Node Palpation (week 56) Abnormal CS	0	—
Musculoskeletal System (week -1) Normal	180	—
Musculoskeletal System (week -1) Abnormal NCS	13	—
Musculoskeletal System (week -1) Abnormal CS	2	—
Musculoskeletal System (week 56) Normal	171	—
Musculoskeletal System (week 56) Abnormal NCS	13	—
Musculoskeletal System (week 56) Abnormal CS	1	—
Respiratory System (week -1) Normal	192	—
Respiratory System (week -1) Abnormal NCS	3	—
Respiratory System (week -1) Abnormal CS	0	—
Respiratory System (week 56) Normal	183	—
Respiratory System (week 56) Abnormal NCS	2	—
Respiratory System (week 56) Abnormal CS	0	—
Skin (week -1) Normal	155	—
Skin (week -1) Abnormal NCS	36	—
Skin (week -1) Abnormal CS	4	—
Skin (week 56) Normal	150	—
Skin (week 56) Abnormal NCS	28	—
Skin (week 56) Abnormal CS	7	—
Thyroid Gland (week -1) Normal	183	—
Thyroid Gland (week -1) Abnormal NCS	10	—
Thyroid Gland (week -1) Abnormal CS	2	—
Thyroid Gland (week 56) Normal	180	—
Thyroid Gland (week 56) Abnormal NCS	5	—
Thyroid Gland (week 56) Abnormal CS	0	—
PlaceboAbdomen (week -1) Normal	169	—
Abdomen (week -1) Abnormal, NCS	25	—
Abdomen (week -1) Abnormal CS	3	—
Abdomen (week 56) Normal	160	—
Abdomen (week 56) Abnormal, NCS	24	—
Abdomen (week 56) Abnormal, CS	3	—
Gastrointestinal System (week -1) Normal	187	—
Gastrointestinal System (week -1) Abnormal NCS	10	—
Gastrointestinal System (week -1) Abnormal CS	0	—
Gastrointestinal System (week 56) Normal	177	—
Gastrointestinal System (week 56) Abnormal NCS	8	—
Gastrointestinal System (week 56) Abnormal CS	0	—
Cardiovascular System (week-1) Normal	182	—
Cardiovascular System (week-1) Abnormal NCS	15	—
Cardiovascular System (week-1) Abnormal CS	0	—
Cardiovascular System (week 56) Normal	175	—
Cardiovascular System (week 56) Abnormal NCS	12	—
Cardiovascular System (week 56) Abnormal CS	0	—
Nervous System (week -1) Normal	159	—
Nervous System (week -1) Abnormal NCS	25	—
Nervous System (week -1) Abnormal CS	13	—
Nervous System (week 56) Normal	149	—
Nervous System (week 56) Abnormal NCS	24	—
Nervous System (week 56) Abnormal CS	14	—
General Appearance (week -1) Normal	150	—
General Appearance (week -1) Abnormal NCS	36	—
General Appearance (week -1) Abnormal CS	11	—
General Appearance (week 56) Normal	151	—
General Appearance (week 56) Abnormal NCS	27	—
General Appearance (week 56) Abnormal CS	9	—
Head, eyes, ENTand Neck (week -1) Normal	182	—
Head, eyes, ENTand Neck (week -1) Abnormal NCS	13	—
Head, eyes, ENTand Neck (week -1) Abnormal CS	2	—
Head, eyes, ENTand Neck (week 56) Normal	173	—
Head, eyes, ENTand Neck (week 56) Abnormal NCS	12	—
Head, eyes, ENTand Neck (week 56) Abnormal CS	2	—
Lymph Node Palpation (week -1) Normal	197	—
Lymph Node Palpation (week -1) Abnormal NCS	0	—
Lymph Node Palpation (week -1) Abnormal CS	0	—
Lymph Node Palpation (week 56) Normal	186	—
Lymph Node Palpation (week 56) Abnormal NCS	0	—
Lymph Node Palpation (week 56) Abnormal CS	0	—
Musculoskeletal System (week -1) Normal	180	—
Musculoskeletal System (week -1) Abnormal NCS	16	—
Musculoskeletal System (week -1) Abnormal CS	1	—
Musculoskeletal System (week 56) Normal	171	—
Musculoskeletal System (week 56) Abnormal NCS	14	—
Musculoskeletal System (week 56) Abnormal CS	2	—
Respiratory System (week -1) Normal	192	—
Respiratory System (week -1) Abnormal NCS	3	—
Respiratory System (week -1) Abnormal CS	2	—
Respiratory System (week 56) Normal	185	—
Respiratory System (week 56) Abnormal NCS	0	—
Respiratory System (week 56) Abnormal CS	2	—
Skin (week -1) Normal	156	—
Skin (week -1) Abnormal NCS	33	—
Skin (week -1) Abnormal CS	8	—
Skin (week 56) Normal	149	—
Skin (week 56) Abnormal NCS	29	—
Skin (week 56) Abnormal CS	9	—
Thyroid Gland (week -1) Normal	187	—
Thyroid Gland (week -1) Abnormal NCS	7	—
Thyroid Gland (week -1) Abnormal CS	3	—
Thyroid Gland (week 56) Normal	178	—
Thyroid Gland (week 56) Abnormal NCS	6	—
Thyroid Gland (week 56) Abnormal CS	3	—

Secondary/registry result

Change in Electrocardiogram (ECG)

Time frame:Week -1, week 56

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 3.0 mgNormal (week -1)	113	—
Abnormal NCS (week -1)	78	—
Abnormal CS (week -1)	4	—
Normal (week 56)	118	—
Abnormal NCS (week 56)	62	—
Abnormal CS (week 56)	5	—
PlaceboNormal (week -1)	133	—
Abnormal NCS (week -1)	60	—
Abnormal CS (week -1)	4	—
Normal (week 56)	126	—
Abnormal NCS (week 56)	57	—
Abnormal CS (week 56)	3	—

Secondary/registry result

Change in Laboratory Measurements (Haematology) - Haemoglobin

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mg	-0.1	—
Placebo	-0.1	—

Secondary/registry result

Change in Laboratory Measurements (Haematology) - Haematocrit

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), Percentage of red blood cells	95% CI
Liraglutide 3.0 mg	-0.4	—
Placebo	-0.2	—

Secondary/registry result

Change in Laboratory Measurements (Haematology) - Erythrocytes

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), 10^12 cells per liter (10^12 cells/L)	95% CI
Liraglutide 3.0 mg	-0.07	—
Placebo	-0.04	—

Secondary/registry result

Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), 10^9 cells/L	95% CI
Liraglutide 3.0 mgThrombocytes	7	—
Leukocytes	-0.22	—
PlaceboThrombocytes	7	—
Leukocytes	-0.24	—

Secondary/registry result

Change in Laboratory Parameters (Biochemistry) - Albumin

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), Grams per deciliter (g/dL)	95% CI
Liraglutide 3.0 mg	-0.1	—
Placebo	-0.1	—

Secondary/registry result

Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), Units per liter (U/L)	95% CI
Liraglutide 3.0 mgAlkaline Phosphatase	-1	—
Alanine Aminotransferase	-5	—
Amylase	13	—
Aspartate aminotransferase	-3	—
Lipase	30	—
PlaceboAlkaline Phosphatase	-0	—
Alanine Aminotransferase	-6	—
Amylase	-1	—
Aspartate aminotransferase	-3	—
Lipase	-8	—

Secondary/registry result

Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), Micromoles per liter (umol/L)	95% CI
Liraglutide 3.0 mgTotal Bilirubin	1.0	—
Creatinine	-0.1	—
PlaceboTotal Bilirubin	0.6	—
Creatinine	-0.2	—

Secondary/registry result

Change in Laboratory Parameters (Biochemistry) - Calcitonin

Time frame:Week 0, week 56

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), Nanograms per liter (ng/L)	95% CI
Liraglutide 3.0 mg	0.0	—
Placebo	0.0	—

Secondary/registry result

Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone

Time frame:Week 0, week 56

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), Milli-international units per liter	95% CI
Liraglutide 3.0 mg	-0.0842	—
Placebo	0.1002	—

Secondary/protocol endpoint

Adverse Events (AEs)

Time frame:Week 0 to week 56 + 30 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Hypoglycaemic Episodes

Time frame:Week 0 to week 56 + 30 days

event count, event

Secondary/protocol endpoint

Change in Physical Examination

Time frame:Week -1, week 56

descriptive

Secondary/protocol endpoint

Change in Electrocardiogram (ECG)

Time frame:Week -1, week 56

categorical status, descriptive

Secondary/protocol endpoint

Change in Laboratory Measurements (Haematology) - Haemoglobin

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Measurements (Haematology) - Haematocrit

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Measurements (Haematology) - Erythrocytes

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Parameters (Biochemistry) - Albumin

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase

Time frame:Week 0, week 56

change from baseline, descriptive

componentsALT, change, AST, change

Secondary/protocol endpoint

Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine

Time frame:Week 0, week 56

change from baseline, descriptive

componentstotal bilirubin change, creatinine change

Secondary/protocol endpoint

Change in Laboratory Parameters (Biochemistry) - Calcitonin

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone

Time frame:Week 0, week 56

change from baseline, descriptive

LOINC 3016-3

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial.
Diabetes care2020 May (month)PMID32139381doi:10.2337/dc19-1745via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.