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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

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

NCTNCT01832532 (opens ClinicalTrials.gov in a new tab)Other idCIN001Pilot 2GLPOther idUL1RR026314
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
34 participants (actual)
Sponsor
Children's Hospital Medical Center, Cincinnati · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Apr 2013
Primary completion
Dec 2015
Completion
Dec 2015
First posted
16 Apr 2013 (estimated)
Last update posted
20 Oct 2020
Conditions
Sleep Apnea · Sleep Disordered Breathing

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 1/2

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

    NCT01832532

    Apr 2013 to Dec 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug

Arms2

  • Experimental

    Treatment group- liraglutide

    Treatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose.

  • No intervention

    Control group

    Control group

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Apnea Hypopnea Index (AHI) From Baseline

    Time frame · Baseline and 4 weeks

    Registry description

    Change in the number of apneas plus hypopnea events per hour of sleep from baseline at end of study.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 4 weeks

Change in Apnea Hypopnea Index (AHI) From Baseline

GroupValue (apnea / hypopnea events per hour sleep)Spread
Treatment Group- Liraglutide38.230
Control Group3420

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Treatment Group- LiraglutideTreatment group- liraglutide daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose. liraglutide: daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose0 / 180 / 180 / 18
Control GroupControl group0 / 90 / 90 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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