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Trial · Interventional

CompletedPhase 4Registry data

Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes

NCTNCT02380521 (opens ClinicalTrials.gov in a new tab)Other idESR-14-10139
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
60 participants (actual)
Sponsor
University of Palermo · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Italy

Start
Jan 2015
Primary completion
Jul 2016
Completion
Nov 2016
First posted
5 Mar 2015 (estimated)
Last update posted
8 Nov 2016 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 4

    Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes

    NCT02380521

    Jan 2015 to Nov 2016

Registry summary

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

The glucagon-like peptide 1 (GLP-1) agonist exenatide represents an effective therapy in patients with type 2 diabetes mellitus (T2DM), which also seems to have some important non-glycemic effects. Yet, these non-glycemic effects are still largely unknown. The effect of exenatide once weekly was investigated in controlled, blinded and open-label clinical studies in subjects with T2DM who were controlled on diet and exercise alone or in combination with oral antidiabetic agents, but also in multi-dose controlled studies and such studies resulted in significant reductions in glycemic parameters (mean glycated hemoglobin (HbA1c), fasting serum/plasma glucose as well as postprandial plasma glucose levels), but also in body weight, over 24 to 30 weeks. Meaningful reductions were observed as early as week 4 of treatment, and maintained through 6 years of treatment. The study investigating cardiovascular effects of exenatide once weekly is currently undergoing. The results available are not numerous (such as DURATION-2, DURATION-3, DURATION-4 studies) and cannot lead to definitive conclusions. In this study the investigators will evaluate the effect of exenatide once-weekly on multiple cardiovascular risk markers. These markers are related to subclinical atherosclerosis, endothelial dysfunction, oxidative stress and atherogenic lipoproteins. The investigators will perform an open label, single-arm, prospective, intervention study using exenatide once weekly for a period of 8 months on 60 patients with T2DM.

Interventions

  • Exenatide once weekly (BYDUREON™)Drug

Arms1

  • Experimental

    60 patients with T2DM

    These patients will be treated with exenatide once weekly for a period of 8 months

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Subclinical atherosclerosis (as measured by cIMT) in patients with T2DM treated with exenatide once weekly

    Time frame · Change from baseline to 8 months of the treatment

    Registry description

    Reduction in cIMT after 8 months of the treatment

Secondary outcomes(3)

  1. Atherogenic lipoproteins (as measured by the analysis of 11 distinct lipoprotein subclasses using the Lipoprint system®) in patients with T2DM treated with exenatide once weekly

    Time frame · Change from baseline to 8 months of the treatment

    Registry description

    Reduction in atherogenic lipoproteins including small dense LDL particles after 8 months of the treatment

  2. Oxidative stress (as measured by markers of oxidative stress) in patients with T2DM treated with exenatide once weekly

    Time frame · Change from baseline to 8 months of the treatment

    Registry description

    Reduction in oxidative stress after 8 months of the treatment

  3. Endothelial dysfunction (as measured by flow mediated dilation of brachial artery) in patients with T2DM treated with exenatide once weekly

    Time frame · Change from baseline to 8 months of the treatment

    Registry description

    Improvement of endothelial dysfunction as indicated by changes in flow mediated dilation of brachial artery after 8 months of the treatment

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

Studies6

Studies that cite this trial.

Studies with results

6 studies on this page

Indexing hint: Randomized controlled trial · 2013

10 results

Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study.

Buse et al. 2013Lancet (London, England)cited by 405

PMID 23141817DOI 10.1016/s0140-6736(12)61267-7PUB-23141817

Full text at the publisher10 results
Publisher pageSee results (10)

Indexing hint: Randomized controlled trial · 2012

10 results

Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study.

Russell-Jones et al. 2012Diabetes carecited by 273

PMID 22210563PMC3263915DOI 10.2337/dc11-1107PUB-22210563

Free to read · publisher termsCC BY-NC-ND10 results
Read at sourceSee results (10)

Indexing hint: Randomized controlled trial · 2011

7 results

DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes.

Blevins et al. 2011The Journal of clinical endocrinology and metabolismcited by 340

PMID 21307137DOI 10.1210/jc.2010-2081PUB-21307137

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Randomized controlled trial · 2010

7 results

Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial.

Bergenstal et al. 2010Lancet (London, England)cited by 457

PMID 20580422DOI 10.1016/s0140-6736(10)60590-9PUB-20580422

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Randomized controlled trial · 2010

2 results

Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial.

Diamant et al. 2010Lancet (London, England)cited by 337

PMID 20609969DOI 10.1016/s0140-6736(10)60406-0PUB-20609969

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2008

2 results

Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study.

Drucker et al. 2008Lancet (London, England)cited by 809

PMID 18782641DOI 10.1016/s0140-6736(08)61206-4PUB-18782641

Full text at the publisher2 results
Publisher pageSee results (2)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures; 2. Men and women with T2DM aged \>18 years; 3. BMI \>25 kg/m2; 4. HbA1c 7.5-8.5 %; 5. Receiving metformin therapy (doses ranging from 1500 to 3000 mg daily) for at least 8 weeks. Exclusion Criteria: 1. Pregnancy or willingness to become pregnant; 2. Moderate and severe liver dysfunction; 3. Moderate and severe renal failure; 4. Previous major cardiovascular event; 5. Severe infections at the discretion of the investigator (such as human immunodeficiency virus \[HIV\], hepatitis B virus \[HBV\] and hepatitis C virus \[HCV\]); 6. Any malignancy; 7. Plasma triglycerides \>400 mg/dL, plasma LDL-cholesterol \> 250 mg/dL.

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