CompletedPhase 3Results posted

A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 25-40•HbA1c 6.5-9.5%

Primary endpoint

•Heart rate, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00516074

Org study IDH8O-MC-GWCD

Timeline

Milestones

Study first posted2007-08-14estimated

Results first posted2009-06-12estimated

Last update posted2015-04-07estimated

Study start2007-09 (month precision)

Primary completion2008-04actual (month precision)

Study completion2008-04actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes.

•Treated with metformin and/or a thiazolidinedione.

•HbA1c between 6.5% and 9.5%, inclusive.

•Body Mass Index (BMI) > 25 kg/m^2 and < 40 kg/m^2.

Exclusion criteria

•Have previously received exenatide or glucagon-like peptide-1 analogs.

•Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.

•Receiving beta blockers.

•Receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.

•Have received treatment with systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators.

•Have been treated with drugs that promote weight loss (for example, Adipex® [phentermine], Acomplia® [rimonabant], Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.

•Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: *Insulin; *Alpha-glucosidase inhibitors (for example, Glyset® [miglitol] or Precose® [acarbose]); *Meglitinides (for example, Prandin® [repaglinide] or Starlix® [nateglinide]); *Sulfonylureas (for example, Glucotrol® [glipizide] or Micronase® [glyburide]); *Dipeptidyl peptidase IV (DPP-IV) inhibitors (for example, Januvia™ [sitagliptin])

•Have donated blood within 60 days of screening.

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

Cardiometabolic biomarkers

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · percent	95% CI
Exenatide BIDBaseline (Week 0)	7.50	-
Change at endpoint (Week 12)	-0.15	-
PlaceboBaseline (Week 0)	7.11	-
Change at endpoint (Week 12)	0.12	-

p0.2600ANCOVA

Cardiometabolic biomarkers

5 endpoints

Primary/protocol endpoint

Change in Mean 24-hour Heart Rate From Baseline to Endpoint

Time frame:12 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Least-squares mean · beats per minute	95% CI
Exenatide BIDBaseline (Week 0)	74.83	-
Change at endpoint (Week 12)	2.14	-
PlaceboBaseline (Week 0)	74.47	-
Change at endpoint (Week 12)	-0.71	-

p0.1585ANCOVA

Secondary/protocol endpoint

Change in Daytime Heart Rate From Baseline to Endpoint

Time frame:12 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Least-squares mean · beats per minute	95% CI
Exenatide BIDBaseline (Week 0)	75.97	-
Change at endpoint (Week 12)	2.35	-
PlaceboBaseline (Week 0)	75.37	-
Change at endpoint (Week 12)	-0.87	-

p0.1624ANCOVA

Secondary/protocol endpoint

Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint

Time frame:12 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Least-squares mean · beats per minute	95% CI
Exenatide BIDBaseline (Week 0)	71.54	-
Change at endpoint (Week 12)	1.43	-
PlaceboBaseline (Week 0)	71.77	-
Change at endpoint (Week 12)	-0.28	-

p0.5077ANCOVA

Secondary/protocol endpoint

Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint

Time frame:12 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Least-squares mean · mmHg	95% CI
Exenatide BIDBaseline (Week 0)	126.61	-
Change at endpoint (Week 12)	-0.81	-
PlaceboBaseline (Week 0)	119.93	-
Change at endpoint (Week 12)	-0.34	-

p0.9034ANCOVA

Secondary/protocol endpoint

Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint

Time frame:12 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Least-squares mean · mmHg	95% CI
Exenatide BIDBaseline (Week 0)	75.70	-
Change at endpoint (Week 12)	-0.60	-
PlaceboBaseline (Week 0)	70.54	-
Change at endpoint (Week 12)	-2.34	-

p0.4270ANCOVA

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study.
Cardiovascular diabetology2010 Jan 28PMID20109208doi:10.1186/1475-2840-9-6via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.