Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Palermo
• Collaborator: AstraZeneca
• Treatments: Exenatide

Criteria

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.