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Is a GLP-1 Agonist in Tablet Form Safe for the Heart?

Clinical Trials Identifier: NCT02692716

Trial name: A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6)

Diabetes type: Type 2 diabetes

What it’s testing: This 19-month research study will test the heart safety of a tablet form (the oral version) of the new GLP-1 agonist semaglutide.

What the trial is measuring: The trial hopes to demonstrate that oral semaglutide does not increase the occurrence of major heart events, such as heart attack or stroke.

Why this is new/important: The SUSTAIN 6 clinical trial (completed last fall) found that an injected version of semaglutide may protect against heart attack and stroke – an exciting benefit of the drug beyond its glucose lowering effects. The current trial is investigating whether a more convenient and easier-to-take tablet version of semaglutide is safe from a heart standpoint. It may also indicate if the tablet version has the same heart benefits as the injected version.

Trial length: 19 months

Trial location: The trial is located at over 200 different locations across the globe. There are US sites in the states of AR, CA, FL, GA, HI, IL, IA, KY, LA, MI, NE, NV, NH, NY, NC, ND, OH, PA, SC, TN, TX, VT, and VA. Sites also exist in Algeria, Argentina, Brazil, Canada, Denmark, Germany, India, Israel, Italy, Malaysia, Mexico, the Netherlands, Poland, Romania, South Africa, Spain, Taiwan, Thailand, Turkey, and the United Kingdom.

Do you qualify?

  • Type 2 diabetes

  • Over 50 years of age with cardiovascular disease OR over 60 years of age with at least one cardiovascular risk factor

For a full list of the trial’s inclusion criteria, please visit its webpage here.

Exclusion criteria include:

  • Current treatment with a GLP-1 agonist, DPP-4 inhibitor, or pramlintide

  • Family or personal history of pancreatitis, multiple endocrine neoplasia type 2 (MEN 2), medullary thyroid carcinoma (MTC), or malignant neoplasms within the past five years

  • History of gastrectomy or gastric bypass surgery

  • Diagnosis of class IV heart failure

  • Previous history of myocardial infarction, stroke, or hospitalization for unstable angina or transient ischemic attack within the past 60 days

  • Dialysis or severe renal impairment

Where to get more information:

Visit the clinical trials page and reach out to your nearest trial location.

Antidote (formerly called TrialReach) is another excellent resource for finding clinical trials. Antidote’s search tool allows you to search for trials by condition (ex. type 1 diabetes, type 2 diabetes, prediabetes) and location. 

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