A trial of 26 weeks of subcutaneous liraglutide (a GLP1 receptor agonist), with or without continuous positive airway pressure (CPAP), in patients with type 2 diabetes mellitus (T2DM) and obstructive sleep apnoea (OSA)

Phase 3

Completed

• Conditions: Diabetes, sleep apnoea; Respiratory

• Registration Number: ISRCTN16250774
• Lead Sponsor: niversity of Liverpool

Brief Summary

2020 protocol in https://pubmed.ncbi.nlm.nih.gov/32699168/ (added 11/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-19
• Study Completion: 2019-10-10
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

1. Males or females, age 18­-75 years
2. Reproductive Status: Definition of Women of Child ­Bearing Potential (WOCBP). WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post­menopausal (see definition below)
3. WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 72 hours before the first dose of study drug.
4. A clinical diagnosis of type 2 diabetes
5. Glycosylated haemoglobin (HbA1c) >53mmol/mol
6. BMI>30kg/ m2
7. Currently treated with either diet or any combination of metformin and sulphonylureas (excluding patients treated with DPP­IV inhibitors*, pioglitazone or insulin)
8. No current use of Liraglutide treatment
9. Patients with moderate­severe OSA as assessed by polysomnographic criteria, either by:
9.1. Apnoea­hypopnea index (AHI) >15 events/hour) with overnight domiciliary multichannel sleep study (ResMed, Apnoea Link™ or other suitable alternative)
9.2. Overnight desaturation index (pulse oximetry): ODI>10 (4% dip in oxygen saturation more than 10 events/hour)
9.3. Currently symptomatic for OSA, with excessive daytime sleepiness

*Patients who are currently treated with DPP­IV inhibitors can be included providing the treatment is discontinued before baseline tests.

Exclusion Criteria

1. Medical History and Concurrent Diseases
2. Females of childbearing age who are not using adequate contraceptive methods or who are planning a pregnancy in the next 6 months
3. Treatment with DPP-IV inhibitors, pioglitazone or subcutaneous insulin injections or with the anti­obesity medication, orlistat
4. Patients in whom there may be occupational implications to a diagnosis of OSA e.g. professional drivers or operating machinery
5. Type 1 diabetes mellitus
6. Congestive heart failure class III­IV
7. Renal impairment: eGFR less than 30 ml/minute/1.73m2
8. Previous history of acute pancreatitis
9. Hyperthyroidism
10. Hypothyroidism (subjects with a normal TSH and free T4, and on a stable dose of thyroxine for at least 3 months may be included)
11. Uncontrolled hypertension (blood pressure >170/120 mmHg)
12. Recent (< 6 months) myocardial infarction
13. Previous stroke (with residual neurological deficit)
14. Significant cardiac dysrhythmias (including pacemaker or ICD)
15. Presence of any other medical condition that would, in the opinion of the investigator or their clinician preclude safe participation in the study. This decision should be informed by Liraglutide precautions for use statements which will be provided to all clinicians and the research team
16. Alcohol consumption in excess of daily recommended limits (21 units/week females, 28 units/week males)
17. Any history of internal metal, pacemakers, or ferromagnetic metallic implants intraocular foreign bodies or cerebral aneurysm clips (exclusion from MR scanning)
18. History of seizures or unexplained syncope
19. Severe sleepiness
20. Weight <140kg (due to limitations of MRI scanner)
21. Subjects with a history of any serious hypersensitivity reaction to GLP1­RA
22. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the study duration plus 8 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized
23. Women who are pregnant or breastfeeding
24. Diabetes treated with pioglitazone, GLP­1 analogues or insulin
25. Use of other weight loss medication or any drug that might affect body weight or appetite (including anti­depressants, antipsychotics, corticosteroids)
26. Prisoners or subjects who are involuntarily incarcerated
27. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
iraglutide treatment