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

NCT01832532 | Completed Phase 1 Results DMC

• 2 other identifiers: CIN001Pilot 2GLPUL1RR026314
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Apnea; Sleep Disordered Breathing

Keywords

Sleep Apnea; Sleep Disordered Breathing; liraglutide; glucagon-like peptide-1 agonist; Orexin; leptin,

Outcome Measures

Primary Outcomes (1)

• Change in Apnea Hypopnea Index (AHI) From Baseline

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

  Baseline and 4 weeks

Study Arms (2)

Treatment group- liraglutide

EXPERIMENTAL

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

Drug: liraglutide

Control group

NO INTERVENTION

Control group

Interventions

liraglutide DRUG

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

Also known as: Other name- Victoza

Treatment group- liraglutide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Raouf Amin, MD
• Organization: Cincinnati Children's Hospital Medical Center

Raouf.Amin@cchmc.org

(513) 636-7945

Study Officials

• Raouf Amin, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 16, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 20, 2020
• Results First Posted: October 20, 2020

Record last verified: 2020-09

Locations

US (1)