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Trial record 71 of 83 for:    PEELING SKIN SYNDROME

Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea

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ClinicalTrials.gov Identifier: NCT01557166
Recruitment Status : Completed
First Posted : March 19, 2012
Results First Posted : February 9, 2015
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Metabolism and Nutrition Disorder
Obesity
Obstructive Sleep Apnoea
Interventions Drug: liraglutide
Drug: placebo
Enrollment 359
Recruitment Details The trial was conducted at 40 sites in 2 countries, as follows: United States: 35 sites; Canada: 5 sites.
Pre-assignment Details The trial consisted of a 2-week screening period before randomisation.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 180 179
Exposed 176 179
Completed 134 142
Not Completed 46 37
Reason Not Completed
Adverse Event             20             6
Lack of Efficacy             2             1
Protocol Violation             8             5
Withdrawn consent             12             20
Target dose not tolerated             1             0
Psychiatric disorder             1             0
Unclassified             2             5
Arm/Group Title Liraglutide 3.0 mg Placebo Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 180 179 359
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 179 participants 359 participants
48.6  (9.9) 48.4  (9.5) 48.5  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 179 participants 359 participants
Female
51
  28.3%
50
  27.9%
101
  28.1%
Male
129
  71.7%
129
  72.1%
258
  71.9%
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 180 participants 179 participants 359 participants
116.5  (23.0) 118.7  (25.4) 117.6  (24.2)
Body mass index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 180 participants 179 participants 359 participants
38.9  (6.4) 39.4  (7.4) 39.1  (6.9)
Apnoea-hypopnoea index (AHI)  
Mean (Standard Deviation)
Unit of measure:  Events/hour
Number Analyzed 180 participants 179 participants 359 participants
49.0  (27.5) 49.3  (27.5) 49.2  (27.4)
Fasting plasma glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 180 participants 179 participants 359 participants
5.4  (0.6) 5.4  (0.9) 5.4  (0.8)
Glycosylated haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percent (%) glycosylated haemoglobin
Number Analyzed 180 participants 179 participants 359 participants
5.7  (0.4) 5.6  (0.4) 5.7  (0.4)
1.Primary Outcome
Title Change From Baseline in Apnoea-hypopnoea Index (AHI)
Hide Description 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.
Time Frame Week 0, Week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - included all randomised subjects. 334 subjects contributed to the statistical analysis.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 168 166
Mean (Standard Deviation)
Unit of Measure: events/hour
-12.22  (23.34) -6.08  (25.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide 3.0 mg, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments 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.
Method of Estimation Estimation Parameter Estimated treatment difference
Estimated Value -6.10
Confidence Interval 95%
-11.0 to -1.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Body Weight (kg)
Hide Description Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.
Time Frame Week 0, week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - included all randomised subjects. 353 subjects contributed to the statistical analysis.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 175 178
Mean (Standard Deviation)
Unit of Measure: kg
-6.73  (6.59) -1.87  (5.44)
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose
Hide Description Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.
Time Frame Week 0, week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - included all randomised subjects. 355 subjects contributed to the statistical analysis.
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 178 177
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.15  (0.69) 0.17  (0.96)
4.Secondary Outcome
Title Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
Hide Description Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.
Time Frame Week 0, week 32
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) - included all randomised subjects. 345 subjects contributed to the statistical analysis
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 174 171
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated haemoglobin
-0.36  (0.30) -0.17  (0.29)
Time Frame Events that either occur before randomisation and increase in severity during the treatment period or have an onset date on or after the first day of randomised treatment and no later than 14 days after the last day of randomised treatment.
Adverse Event Reporting Description Safety analysis set – included all randomised subjects exposed to trial drug.
 
Arm/Group Title Liraglutide 3.0 mg Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Liraglutide 3.0 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Liraglutide 3.0 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/176 (3.41%)      6/179 (3.35%)    
Cardiac disorders     
Angina pectoris  1  2/176 (1.14%)  3 0/179 (0.00%)  0
Angina unstable  1  0/176 (0.00%)  0 1/179 (0.56%)  1
Myocardial infarction  1  0/176 (0.00%)  0 1/179 (0.56%)  1
Sinus arrest  1  1/176 (0.57%)  1 0/179 (0.00%)  0
Gastrointestinal disorders     
Gastrooesophageal reflux disease  1  0/176 (0.00%)  0 1/179 (0.56%)  1
Obstruction gastric  1  0/176 (0.00%)  0 1/179 (0.56%)  1
Hepatobiliary disorders     
Cholecystitis  1  0/176 (0.00%)  0 1/179 (0.56%)  1
Cholelithiasis  1  1/176 (0.57%)  1 0/179 (0.00%)  0
Infections and infestations     
Pneumonia  1  1/176 (0.57%)  1 0/179 (0.00%)  0
Injury, poisoning and procedural complications     
Procedural pain  1  1/176 (0.57%)  1 0/179 (0.00%)  0
Spinal fracture  1  1/176 (0.57%)  1 0/179 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/176 (0.57%)  1 0/179 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bone lesion  1  0/176 (0.00%)  0 1/179 (0.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer  1  0/176 (0.00%)  0 1/179 (0.56%)  1
Psychiatric disorders     
Anxiety  1  1/176 (0.57%)  1 0/179 (0.00%)  0
Depression suicidal  1  1/176 (0.57%)  1 0/179 (0.00%)  0
Nightmare  1  0/176 (0.00%)  0 1/179 (0.56%)  1
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal swelling  1  1/176 (0.57%)  1 0/179 (0.00%)  0
Sleep apnoea syndrome  1  1/176 (0.57%)  1 0/179 (0.00%)  0
Surgical and medical procedures     
Coronary revascularisation  1  1/176 (0.57%)  1 1/179 (0.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Liraglutide 3.0 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   117/176 (66.48%)      84/179 (46.93%)    
Gastrointestinal disorders     
Constipation  1  21/176 (11.93%)  26 6/179 (3.35%)  7
Diarrhoea  1  29/176 (16.48%)  38 14/179 (7.82%)  17
Dyspepsia  1  15/176 (8.52%)  20 2/179 (1.12%)  2
Gastrooesophageal reflux disease  1  10/176 (5.68%)  11 0/179 (0.00%)  0
Nausea  1  47/176 (26.70%)  59 12/179 (6.70%)  14
Vomiting  1  13/176 (7.39%)  16 5/179 (2.79%)  5
General disorders     
Injection site haematoma  1  7/176 (3.98%)  8 13/179 (7.26%)  14
Infections and infestations     
Influenza  1  9/176 (5.11%)  12 9/179 (5.03%)  9
Nasopharyngitis  1  15/176 (8.52%)  19 18/179 (10.06%)  20
Upper respiratory tract infection  1  18/176 (10.23%)  25 19/179 (10.61%)  25
Investigations     
Lipase increased  1  9/176 (5.11%)  11 5/179 (2.79%)  6
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/176 (3.98%)  7 9/179 (5.03%)  9
Nervous system disorders     
Headache  1  25/176 (14.20%)  26 20/179 (11.17%)  23
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Novo Nordisk maintains the right to be informed of plans by any investigator to publish and to review any scientific paper, presentation, communication or other information concerning the investigation described in the protocol. Novo Nordisk reserves the right to prior review of such publications and to ask for deferment of publication of individual site results until after the primary manuscript is accepted for publication.
Results Point of Contact
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01557166     History of Changes
Other Study ID Numbers: NN8022-3970
U1111-1126-6260 ( Other Identifier: WHO )
First Submitted: March 15, 2012
First Posted: March 19, 2012
Results First Submitted: January 22, 2015
Results First Posted: February 9, 2015
Last Update Posted: November 1, 2017