A Pilot Study of the Effects on Sleep Disordered Breathing (SDB) When Using the Drug Liraglutide for 4 Weeks

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, controlled study.

The investigators are studying if the FDA approved diabetes medicine liraglutide (Victoza®) can improve sleep apnea in adults. This study is testing liraglutide in 20 adults without diabetes that are diagnosed with sleep apnea.The treatment group will be compared to a control group of 10 adults without diabetes who have sleep apnea but will not use liraglutide. Both groups will continue receiving standard of care for their sleep apnea as prescribed by their managing sleep physician throughout their study participation.

Everyone in the study will have two study visits and one overnight sleep study for research. Subjects who have not had a recent sleep study but otherwise qualify for the study, will have an additional research sleep study to determine the baseline severity of their sleep apnea. The study visits include fasting blood samples and breathing tests (pulmonary function test and hypercapnic challenge). There will be weekly phone visits that include a questionnaire on sleepiness. The group that takes liraglutide will check their blood sugar two times a day while on the medicine.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Glucagon; Glucagon-Like Peptide 1; Liraglutide

Criteria

Inclusion Criteria:

• Age 18-60 years

• Diagnosis of severe obstructive sleep apnea (OSA) AHI ≥ 8 /hour of sleep

• Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule

• BMI of ≥ 27

• For Cohort 1: If female of childbearing capacity, willing to use acceptable birth control during use of study drug

Exclusion Criteria:

• A major medical condition such as renal or hepatic failure

• 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 judgment of the investigator

• BMI < 27

• History of glycosylated hemoglobin (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 or drugs in the incretin family within the previous 3 months prior to screening

• Previous surgical treatment for obesity

• Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial Medullary Thyroid Carcinoma

• Personal or immediate family history of thyroid cancer

• 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

• History of alcoholism

• Pregnancy or breastfeeding