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.