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Tirzepatide vs insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): A randomized, open-label, parallel-group, multicentre, phase 3 trial

The Lancet Oct 24, 2021

Del Prato S, Kahn SE, Pa I, et al. - Treatment of type 2 diabetes cases with high cardiovascular risk using tirzepatide (dual GIP and GLP-1 receptor agonist) provided a greater and clinically meaningful glycated hemoglobin (HbA 1c ) reduction with a lower incidence of hypoglycemia at week 52, relative to glargine. No excess cardiovascular risk was noted in relation to tirzepatide use.

  • An open-label, parallel-group, phase 3 study of 2002 adults with type 2 diabetes and high cardiovascular risk inadequately controlled on oral glucose-lowering medications.

  • Patients were randomly assigned to tirzepatide or glargine.

  • Mean HbA 1c changes at 52 weeks were −2·43% and −2·58% with 10 mg and 15 mg doses of tirzepatide, respectively, vs −1·44% with glargine; the non-inferiority margin of 0·3% was met for both doses of tirzepatide.

  • Mostly mild to moderate adverse effects were more frequent with tirzepatide than glargine.

  • With tirzepatide, no increase occurred in adjudicated major adverse cardiovascular events (MACE)-4 events (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina), vs glargine (hazard ratio 0·74).

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