Impact of Exenatide on Sleep in Type 2 Diabetes

NCT01136798 | Completed Results

• 1 other identifier: 09-291-B
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.

Conditions

Type 2 Diabetes; Sleep Disordered Breathing

Keywords

slow wave sleep; exenatide and sleep

Outcome Measures

Primary Outcomes (2)

• Non-REM Slow Wave Sleep

  Total minutes of non-REM sleep was measured

  baseline and after 6 weeks of treatment

• Total Amount of Slow Wave Activity

  Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured

  baseline and after 6 weeks of treatment

Secondary Outcomes (4)

• Sleep Efficiency During Polysomnographic Recording

  baseline and after 6 weeks of treatment

• Minutes of Wake After Sleep Onset During Sleep Recording

  baseline and after 6 weeks of treatment

• Severity of Obstructive Sleep Apnea

  baseline and after 6 weeks of treatment

• Mean 24-h Blood Glucose Levels

  baseline and after 6 weeks of treatment

Study Arms (2)

Usual T2 DM med regimen

PLACEBO COMPARATOR

Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.

Drug: Placebo

Usual T2 DM med regimen plus Exenatide

EXPERIMENTAL

Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.

Drug: Exenatide

Interventions

Exenatide DRUG

Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

Usual T2 DM med regimen plus Exenatide

Placebo DRUG

Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

Usual T2 DM med regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.

You may not qualify if:

• Patients with unstable cardiac, neurological or psychiatric disease
• Women who are pregnant or report trying to get pregnant will be excluded.
• Patients treated for obstructive sleep apnea (OSA) will be excluded.
• Patients with established OSA will be included only if they have declined treatment of OSA.
• Patients with morbid obesity (BMI ≥ 40 gk/m2)
• Patients on insulin
• Patients already taking an incretin-based drug will not be included
• Patients with renal disease (creatinine clearance \<30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
• Patients taking an insulin secretagogue will be excluded.
• Patients with Hemoglobin A1c values greater than or equal to 10 will be excluded.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (2)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sleep Apnea Syndromes

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Limitations and Caveats

When the investigators were unblinded in August 2016, a randomization error originating from the industry sponsor was identified, where only 8 participants were randomized to exenatide while 10 were randomized to placebo.

Results Point of Contact

• Title: Eve Van Cauter, PhD
• Organization: The University of Chicago

evcauter@bsd.uchicago.edu

773-834-4001

Study Officials

• Eve Van Cauter, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: June 3, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 12, 2018
• Results First Posted: July 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)