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. 2017 May 10;2017(5):CD012204. doi: 10.1002/14651858.CD012204.pub2

SCALE‐SLEEP.

Methods Allocation: randomised
Intervention model: parallel
Masking: double blind (participants and investigators)
Participants Condition: normoglycaemia and intermediate hyperglycaemia
Enrolment: in total 359 participants; the abstract stated that 63.2% of participants had intermediate hyperglycaemia at baseline
Inclusion criteria: informed consent; BMI ≥ 30 kg/m²; stable body weight (< 5% self‐reported change during the previous 3 months); diagnosis of moderate or severe obstructive sleep apnoea; unwilling or unable to use continuous positive airway pressure (or other positive airway pressure) treatment. No continuous positive airway pressure (or other positive airway pressure) treatment for at least 4 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 receptor agonists, DPP‐4 inhibitors or insulin within the last 3 months prior to screening; diagnosis of T1DM or T2DM per judgement of investigator; HbA1c ≥ 6.5%; significant craniofacial abnormalities that may cause obstructive sleep apnoea; respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of investigator; use of central stimulants, hypnotics, mirtazapine, opioids or trazodone within the previous 3 months prior to screening; obesity induced by drug treatment; treatment with pramlintide, sibutramine, orlistat, zonisamide, topiramate or phentermine within the last 3 month prior to screening; previous surgical treatment for obesity; screening calcitonin ≥ 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 ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg (or both)
Interventions Intervention: liraglutide 3.0 mg, subcutaneous
Comparator: placebo, subcutaneous
Duration of intervention: 32 weeks
Outcomes Primary outcome: change from baseline in apnoea‐hypopnoea index
Secondary outcomes: change from baseline in body weight; glycaemic measures
Study details Trial terminated early: no
Publication details Language of publication: English
Funding: commercial funding
Publication status: peer‐reviewed journal/full article
Stated aim of study Quote: "The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea."
Notes Application sent to Novo Nordisk to request separate data on the participants with intermediate hyperglycaemia. Novo Nordisk has approved access to raw trial data, but data are not yet available

18F‐FDG PET‐CT: 18‐fluorodeoxyglucose positron emission tomography computed tomography; BAT: brown adipose tissue; BMI: body mass index; DEXA: dual‐energy x‐ray absorptiometry; DPP‐4: dipeptidyl‐peptidase‐4; h: hour; HbA1c: glycosylated haemoglobin A1c; HDL: high‐density lipoprotein; LDL: low‐density lipoprotein; OGTT: oral glucose tolerance test; PO: per os (orally); NR: not reported; T1DM: type 1 diabetes mellitus; T2DM: type 2 diabetes mellitus.