A randomized, placebo controlled clinical trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with type 2 diabetes mellitus. EXSCEL Trial, Protocol BCB109.

  • STATUS
    Recruiting
  • sponsor
    Amylin Pharmaceut.
Updated on 25 March 2021

Summary

A randomized, placebo controlled clinical trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with type 2 diabetes mellitus. EXSCEL Trial, Protocol BCB109.

Description

The primary objective of this study will be to evaluate the effect of EQW, used in addition to the current usual care for glycemic control, on major macrovascular events when administered to patients with type 2 diabetes.

For additional information regarding this clinical trial, please call our site at (203) 419-4404

Details
Condition Diabetes and Hypertension
Clinical Study IdentifierTX138727
SponsorAmylin Pharmaceut.
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient has type 2 diabetes mellitus
Patient will be able to see a usual care provider at least twice a year
Patient has an HbA1c of ≥6.5 % and ≥10.0% and is currently using one of the following treatment regimens
Treatment with up to three (i.e., 0-3) oral AHAs (concomitant use of DPP-4 inhibitors is permitted)
Insulin therapy, either alone or in combination with up to two (i.e., 0-2) oral AHAs (use of basal and prandial insulins is permitted in any combination of individual or premixed insulins)
All patients should be on a stable diabetes management regimen, as assessed by the investigator, at the time of enrollment
Patients with any level of CV risk and meeting all other inclusion criteria may be enrolled. Recruitment will be constrained (see Section 6.3) such that approximately 30% will not have had a prior CV event and 70% will have had a prior CV event. A prior CV event is defined as at least one of the following
History of a major clinical manifestation of coronary artery disease i.e. myocardial infarction, surgical or percutaneous (balloon and/or stent) coronary revascularization procedure, or coronary angiography showing at least one stenosis ≥50% in a major epicardial artery or branch vessel
Ischemic cerebrovascular disease, including
History of Ischemic stroke; strokes not known to be hemorrhagic will be allowed as part of this criterion; transient ischemic attacks (TIAs) are not included
History of carotid arterial disease as documented by ≥50 % stenosis documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography, with or without symptoms of neurologic deficit
Atherosclerotic peripheral arterial disease, as documented by objective evidence such as amputation due to vascular disease, current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index or toe brachial pressure index less than 0.9, or history of surgical or percutaneous revascularization procedure
Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant

Exclusion Criteria

Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis
Patient has a history (≥2 episodes) of severe hypoglycemia within 12 months of enrollment
Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g., BYETTA (exenatide), BYDUREON (EQW), VICTOZA (liraglutide), LYXUMIA (lixisenatide), albiglutide, taspoglutide, or dulaglutide
Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial
Patient has a planned or anticipated revascularization procedure
Pregnancy or planned pregnancy during the trial period
Patient has medical history that indicates a life expectancy of <2 years or might limit the individual’s ability to take trial treatments for the duration of the trial
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