NCT02380521

Effect of Exenatide Once Weekly on Cardiovascular Risk Markers in Patients With Type-2 Diabetes

Completed Phase 4 Last updated 6 November 2016

What this trial tests

Phase 4 trial testing Exenatide once weekly (BYDUREON™) in Type 2 Diabetes Mellitus in 60 participants. Completed in 1 November 2016.

Timeline

1 January 2015

Primary endpoint
1 July 2016

1 November 2016

Quick facts

Lead sponsor	University of Palermo
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 January 2015
Primary completion	1 July 2016
Estimated completion	1 November 2016
Sites	1 location across Italy

Drugs / interventions tested

• Exenatide once weekly (BYDUREON™) — full drug profile →

Conditions studied

• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

University of Palermo

Who can join

Adults 18 to 80, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  Reduction in cIMT after 8 months of the treatment

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current perspectives on cardiovascular outcome trials in diabetes.
   Schnell O, Rydén L, Standl E, Ceriello A, et al · · 2016 · cited 46× · PMID 27716274 · DOI 10.1186/s12933-016-0456-8
2. 53 <sup>rd</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Lisbon, Portugal, 11 - 15 September 2017.
   · 2017 · cited 17× · PMID 28795195 · DOI 10.1007/s00125-017-4350-z
3. Impact of monotherapy and combination therapy with glucagon-like peptide-1 receptor agonists on exosomal and non-exosomal MicroRNA signatures in type 2 diabetes mellitus: a systematic review.
   Yu H, Davoudi M, Sadegh-Nejadi S, Miao X, et al · · 2025 · cited 4× · PMID 40281607 · DOI 10.1186/s12967-025-06461-y