ISRCTN16250774已完成3 期
A randomised, controlled multi-centre 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)
niversity of Liverpool0 个研究点目标入组 152 人开始时间: 2015年8月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
研究概览
简要总结
2020 protocol in https://pubmed.ncbi.nlm.nih.gov/32699168/ (added 11/12/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
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