CompletedPhase 2, PHASE3

The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET

The Effect of the GLP-1 Analogue Exenatide on Glucose Metabolism in the CNS and Heart During Hyperglycemia in Type-2 Diabetic Patients Assessed by PET

Lead sponsor

University of Aarhus

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 20-45•HbA1c 7.1-11%•Male

Primary endpoint

•Steady glucose metabolism in the heart and brain during hyperglycemia

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 IDNCT00747968

Org study IDBrainandheart

Timeline

Milestones

Study first posted2008-09-08estimated

Last update posted2011-06-30estimated

Study start2010-02 (month precision)

Primary completion2010-11actual (month precision)

Study completion2011-03actual (month precision)

Assets

Investigational agents

Exenatide GLP-1 / incretin class catch-all

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age50 Years

Maximum age70 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent signed

•Caucasian

•Male

•Diabetes for > 6 months

•Diet treatment or a single OAD (metformin, SU)

•Age > 50 years and < 70 years

•BMI 20-45 kg/m²

•Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11% inclusive.

•Fasting PG 7-10 mmol/l

•OAD discontinued 72 hours prior to study day 1

Exclusion criteria

•Clinically significant liver- or kidney-disease (se-ALAT > 2 times upper reference, or se-Creatinin > 130 mM

•Anemia

•Other abnormal biochemical value

•Any of the following:

-Heart disease

-Liver disease

-Kidney disease

-Lung disease

-Gastro-intestinal disease

-Dyslipidemia (total serum-cholesterol > 8 mmol/l, total cholesterol/HDL cholesterol ratio > 8 or se-triglyceride > 3.5 mmol/l)

-Endocrine disease (other than diabetes)

-CNS disease

-Hematological disease

-Loss of more than 100 ml blood within the latest month of inclusion

-Compliance problems

-Abuse of alcohol or drugs

-Smoking

-Participation in a clinical research study within 3 months of inclusion

-Allergy towards study hormones

-Medication with any drugs with effects on the glucose-metabolism, including *glitazones

Endpoints (1)

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.

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

steady glucose metabolism in the heart and brain during hyperglycemia with GLP-1-analogue infusion compared to placebo.

Time frame:oct. 2008 - oct 2010

descriptive

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

Exenatide alters myocardial glucose transport and uptake depending on insulin resistance and increases myocardial blood flow in patients with type 2 diabetes.
The Journal of clinical endocrinology and metabolism2012 Jul (month)PMID22544917doi:10.1210/jc.2011-3456via 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 tableno registry results posted yet

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.