Trial · Interventional

CompletedPhase 2/3Registry data

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

NCTNCT00747968Other idBrainandheart

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Overview

Status: Completed
Phase: Phase 2/3
Enrollment: 8 participants (actual)
Sponsor: University of Aarhus · Other
Design: Randomized · Triple masking
Countries: 1 country
Denmark
Start: Feb 2010
Primary completion: Nov 2010
Completion: Mar 2011
First posted: 8 Sept 2008 (estimated)
Last update posted: 30 Jun 2011 (estimated)
Conditions: Type 2 Diabetes

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020112012

Ph 2/3
The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET
NCT00747968
Feb 2010 to Mar 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

30 type 2 diabetic patients will be PET-scanned twice ( half of the patients heart-PET, half of the patients CNS-PET) in random order with infusions of placebo or GLP-1-analogue during hyperglycemic clamp to uncover the metabolic effects of GLP-1-analogues in perspectives of intervention of macrovascular late diabetic pathology such as stroke and AMI. Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS despite fluctuations in blood sugar when infusing native GLP-1.

Interventions

Byetta, ExenatideDrug

Arms2

Active comparator
glp-1-analogue
During hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be heart OR CNS-PET scanned
Placebo comparator
placebo
During hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be CNS OR heart-PET scanned.

Primary outcomes1

Outcomes the sponsor listed as primary.

steady glucose metabolism in the heart and brain during hyperglycemia with GLP-1-analogue infusion compared to placebo.
Time frame · oct. 2008 - oct 2010

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

6 results

Exenatide alters myocardial glucose transport and uptake depending on insulin resistance and increases myocardial blood flow in patients with type 2 diabetes.

Gejl et al. 2012The Journal of clinical endocrinology and metabolismcited by 64

PMID 22544917DOI 10.1210/jc.2011-3456PUB-22544917

Rights unknown6 results

Source link See results (6)

Eligibility

Who could join, as posted.

Sex: Male
Age: from 50 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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