Phase 3 · Liraglutide

NCT01557166 trial results

Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea. A 32 Week Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre and Multinational Trial

Change From Baseline in Apnoea-hypopnoea Index (AHI) (events/hour), Week 0, Week 32. Liraglutide 3.0 mg: -12.22; Placebo: -6.08.

Participants
359
Status
completed
Completed
2013-06-17
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT01557166), updated at source Nov 1, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01557166 measured first

Change From Baseline in Apnoea-hypopnoea Index (AHI)events/hour · Week 0, Week 32 · mean
Liraglutide 3.0 mgn=168Placebon=166
-12.22(23.34)-6.08(25.90)
Side effects by arm

Side effects in NCT01557166

Percent of participants affected, 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.... The most common events the registry lists.

EventLiraglutide 3.0 mgPlacebo
Any serious event3.4%3.4%
Nausea26.7%6.7%
Diarrhoea16.5%7.8%
Headache14.2%11.2%
Constipation11.9%3.4%
Upper respiratory tract infection10.2%10.6%
Nasopharyngitis8.5%10.1%
Dyspepsia8.5%1.1%
Vomiting7.4%2.8%
Injection site haematoma4%7.3%
Gastrooesophageal reflux disease5.7%0%
Influenza5.1%5%
Lipase increased5.1%2.8%
Arthralgia4%5%
Secondary outcomes

What else it measured

Change From Baseline in Body Weight (kg)kg · Week 0, week 32 · mean
Liraglutide 3.0 mgn=175Placebon=178
-6.73(6.59)-1.87(5.44)
Change From Baseline in Fasting Plasma Glucosemmol/L · Week 0, week 32 · mean
Liraglutide 3.0 mgn=178Placebon=177
-0.15(0.69)0.17(0.96)
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)percentage of glycosylated haemoglobin · Week 0, week 32 · mean
Liraglutide 3.0 mgn=174Placebon=171
-0.36(0.30)-0.17(0.29)
The trial

How NCT01557166 was run

This trial is conducted in North America. The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea.

  • Liraglutide 3.0 mg
  • Placebo
Who could join the trial

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

Published papers

Papers from NCT01557166

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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