GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01136798

CompletedPhase NAResults posted

Impact of Exenatide on Sleep in Type 2 Diabetes

Impact of Exenatide on Sleep and Circadian Function in Type 2 Diabetes: A Pilot Study

Lead sponsor

University of Chicago

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•Non-REM Slow Wave Sleep•Total Amount of Slow Wave Activity

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01136798

Org study ID09-291-B

Timeline

Milestones

Study start2010-06-01actual

Study first posted2010-06-03estimated

Primary completion2016-09-01actual

Study completion2016-09-01actual

Results first posted2018-07-31actual

Last update posted2018-09-12actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

Exclusion criteria

•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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Mean 24-h Blood Glucose Levels

Time frame:baseline and after 6 weeks of treatment

change from baseline, improvement

Posted result

Group	Value (mean), mg/dl	95% CI
Usual T2 DM Med RegimenBaseline	134.4	—
At 6 week	141.3	—
Usual T2 DM Med Regimen Plus ExenatideBaseline	142.2	—
At 6 week	136.1	—

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Non-REM Slow Wave Sleep

Time frame:baseline and after 6 weeks of treatment

change from baseline, improvement

Posted result

Group	Value (mean), minutes	95% CI
Usual T2 DM Med RegimenBaseline	47.3	—
At 6 week	57.3	—
Usual T2 DM Med Regimen Plus ExenatideBaseline	34.3	—
At 6 week	41.4	—

Primary/protocol endpoint

Total Amount of Slow Wave Activity

Time frame:baseline and after 6 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Sleep Efficiency During Polysomnographic Recording

Time frame:baseline and after 6 weeks of treatment

descriptive

Posted result

Group	Value (mean), percentage of total recording time	95% CI
Usual T2 DM Med RegimenBaseline	84.3	—
At 6 week	83.8	—
Usual T2 DM Med Regimen Plus ExenatideBaseline	85.3	—
At 6 week	89.4	—

Secondary/protocol endpoint

Minutes of Wake After Sleep Onset During Sleep Recording

Time frame:baseline and after 6 weeks of treatment

change from baseline, improvement

Posted result

Group	Value (mean), minutes	95% CI
Usual T2 DM Med RegimenBaseline	70.4	—
At 6 week	52.3	—
Usual T2 DM Med Regimen Plus ExenatideBaseline	56.6	—
At 6 week	36.6	—

Secondary/protocol endpoint

Severity of Obstructive Sleep Apnea

Time frame:baseline and after 6 weeks of treatment

AHI, change

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Usual T2 DM Med RegimenBaseline	15.9	—
At 6 week	16.5	—
Usual T2 DM Med Regimen Plus ExenatideBaseline	16.4	—
At 6 week	10.9	—

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.