Effect of Liraglutide in Obese Subjects With Moderate or... | NCT01557166

ID	Type	Description	Link
U1111-1126-6260	Other Identifier	WHO

Label	Type	Description	Intervention Names
Liraglutide 3.0 mg	Experimental		Drug: liraglutide
Placebo	Placebo Comparator		Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise	Liraglutide 3.0 mg

Measure	Description	Time Frame
Change From Baseline in Apnoea-hypopnoea Index (AHI)	Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0-14.9; moderate 15.0-29.9; severe ≥30.0 events/hour.	Week 0, Week 32

Measure	Description	Time Frame
Change From Baseline in Body Weight (kg)	Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.	Week 0, week 32
Change From Baseline in Fasting Plasma Glucose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent
Body mass index equal to or above 30 kg/m^2
Stable body weight (less than 5% self-reported change during the previous 3 months)
Diagnosis of moderate or severe obstructive sleep apnoea (OSA)
Unwilling or unable to use continuous positive airway pressure (CPAP) (or other positive airway pressure) treatment. No CPAP (or other positive airway pressure) treatment for at least four weeks prior to screening
Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule and dietary advice and complete trial related questionnaires

Exclusion Criteria:

Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 inhibitors or insulin within the last 3 months prior to screening
Diagnosis of type 1 or type 2 diabetes per judgement of the investigator
Glycosylated haemoglobin (HbA1c) equal to or above 6.5%
Significant craniofacial abnormalities that may cause OSA
Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator
Use of central stimulants, hypnotics, mirtazepine, opioids, trazodone within the previous 3 months prior to screening
Obesity induced by drug treatment
Treatment with pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine within the last 3 month prior to screening
Previous surgical treatment for obesity
Screening calcitonin equal to or above 50 ng/L
Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial Medullary Thyroid Carcinoma
Personal history of non-familial Medullary Thyroid Carcinoma
History of chronic pancreatitis or idiopathic acute pancreatitis
History of Major Depressive Disorder or suicide attempts
Systolic blood pressure equal to or above 160 mmHg and/or diastolic blood pressure equal to or above 100 mmHg

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Glendale	California	91206	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
27482610	Result	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.
27817208

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Liraglutide 3.0 mg	Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00048.6± 9.9 BG00148.4± 9.5 BG00248.5± 9.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00051 BG00150 BG002

Body weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000116.5± 23.0 BG001118.7± 25.4 BG002

Body mass index (BMI)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00038.9± 6.4 BG00139.4± 7.4 BG002

Apnoea-hypopnoea index (AHI)

Mean

Standard Deviation

events/hour

Title

Denominators

Categories

Title	Measurements
	BG00049.0± 27.5 BG00149.3± 27.5 BG002

Fasting plasma glucose (FPG)

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0005.4± 0.6 BG0015.4± 0.9 BG002

Glycosylated haemoglobin (HbA1c)

Mean

Standard Deviation

Percent (%) glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0005.7± 0.4 BG0015.6± 0.4 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Apnoea-hypopnoea Index (AHI)

Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0-14.9; moderate 15.0-29.9; severe ≥30.0 events/hour.

Full analysis set (FAS) - included all randomised subjects. 334 subjects contributed to the statistical analysis.

Posted

Mean

Standard Deviation

events/hour

Week 0, Week 32

ID	Title	Description
OG000	Liraglutide 3.0 mg	Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
OG001	Placebo	Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.

Units	Counts
Participants	OG000168 OG001166

Title

Denominators

Categories

Title	Measurements
	OG000-12.22± 23.34 OG001-6.08± 25.90

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Let μ liraglutide 3.0mg and μ placebo denote mean change in AHI for liraglutide 3.0 mg and placebo,respectively. The null-hypothesis and the alternative was H0: μliraglutide 3.0mg = μplacebo against the alternative HA: μliraglutide 3.0mg ≠ μplacebo.	ANCOVA	ANCOVA model was used with treatment, country and sex as fixed factors, and the baseline value of AHI, baseline BMI and baseline age as covariates.	0.015		Estimated treatment difference	-6.10				95	-11.0	-1.19					Superiority or Other

Secondary

Change From Baseline in Body Weight (kg)

Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.

Full analysis set (FAS) - included all randomised subjects. 353 subjects contributed to the statistical analysis.

Posted

Mean

Standard Deviation

Week 0, week 32

ID	Title	Description
OG000	Liraglutide 3.0 mg	Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
OG001	Placebo	Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fasting Plasma Glucose

Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.

Full analysis set (FAS) - included all randomised subjects. 355 subjects contributed to the statistical analysis.

Posted

Mean

Standard Deviation

mmol/L

Week 0, week 32

ID	Title	Description
OG000	Liraglutide 3.0 mg	Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
OG001	Placebo	Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)

Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.

Full analysis set (FAS) - included all randomised subjects. 345 subjects contributed to the statistical analysis

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, week 32

ID	Title	Description
OG000	Liraglutide 3.0 mg	Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
OG001	Placebo	Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA, version 15.1	Systematic Assessment	EG0003 events2 affected176 at risk EG0010 events0 affected179 at risk
Angina unstable	Cardiac disorders	MedDRA, version 15.1	Systematic Assessment	EG0000 events0 affected176 at risk EG0011 events1 affected179 at risk
Myocardial infarction	Cardiac disorders	MedDRA, version 15.1	Systematic Assessment	EG0000 events0 affected176 at risk EG0011 events1 affected179 at risk
Sinus arrest	Cardiac disorders	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0010 events0 affected179 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA, version 15.1	Systematic Assessment	EG0000 events0 affected176 at risk EG0011 events1 affected179 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA, version 15.1	Systematic Assessment	EG0000 events0 affected176 at risk EG0011 events1 affected179 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA, version 15.1	Systematic Assessment	EG0000 events0 affected176 at risk EG0011 events1 affected179 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0010 events0 affected179 at risk
Pneumonia	Infections and infestations	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0010 events0 affected179 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0010 events0 affected179 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0010 events0 affected179 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0010 events0 affected179 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA, version 15.1	Systematic Assessment	EG0000 events0 affected176 at risk EG0011 events1 affected179 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, version 15.1	Systematic Assessment	EG0000 events0 affected176 at risk EG0011 events1 affected179 at risk
Anxiety	Psychiatric disorders	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0010 events0 affected179 at risk
Depression suicidal	Psychiatric disorders	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0010 events0 affected179 at risk
Nightmare	Psychiatric disorders	MedDRA, version 15.1	Systematic Assessment	EG0000 events0 affected176 at risk EG0011 events1 affected179 at risk
Oropharyngeal swelling	Respiratory, thoracic and mediastinal disorders	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0010 events0 affected179 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0010 events0 affected179 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA, version 15.1	Systematic Assessment	EG0001 events1 affected176 at risk EG0011 events1 affected179 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA, version 15.1	Systematic Assessment	EG00026 events21 affected176 at risk EG0017 events6 affected179 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA, version 15.1	Systematic Assessment	EG00038 events29 affected176 at risk EG00117 events14 affected179 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA, version 15.1	Systematic Assessment	EG00020 events15 affected176 at risk EG0012 events2 affected179 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA, version 15.1	Systematic Assessment	EG00011 events10 affected176 at risk EG0010 events0 affected179 at risk
Nausea	Gastrointestinal disorders	MedDRA, version 15.1	Systematic Assessment	EG00059 events47 affected176 at risk EG00114 events12 affected179 at risk
Vomiting	Gastrointestinal disorders	MedDRA, version 15.1	Systematic Assessment	EG00016 events13 affected176 at risk EG0015 events5 affected179 at risk
Injection site haematoma	General disorders	MedDRA, version 15.1	Systematic Assessment	EG0008 events7 affected176 at risk EG00114 events13 affected179 at risk
Influenza	Infections and infestations	MedDRA, version 15.1	Systematic Assessment	EG00012 events9 affected176 at risk EG0019 events9 affected179 at risk
Nasopharyngitis	Infections and infestations	MedDRA, version 15.1	Systematic Assessment	EG00019 events15 affected176 at risk EG00120 events18 affected179 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA, version 15.1	Systematic Assessment	EG00025 events18 affected176 at risk EG00125 events19 affected179 at risk
Lipase increased	Investigations	MedDRA, version 15.1	Systematic Assessment	EG00011 events9 affected176 at risk EG0016 events5 affected179 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA, version 15.1	Systematic Assessment	EG0007 events7 affected176 at risk EG0019 events9 affected179 at risk
Headache	Nervous system disorders	MedDRA, version 15.1	Systematic Assessment	EG00026 events25 affected176 at risk EG00123 events20 affected179 at risk

ID	Term
D009748	Nutrition Disorders
D009765	Obesity
D020181	Sleep Apnea, Obstructive

ID	Term
D009750	Nutritional and Metabolic Diseases
D050177	Overweight
D044343	Overnutrition
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description
BG000	Liraglutide 3.0 mg	Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
BG001	Placebo	Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Liraglutide 3.0 mg	Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.			6	176	117	176
EG001	Placebo	Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.			6	179	84	179