The trial is taking place at:
M

Mercury Street Medical Group, PLLC | Butte, MT

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A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes (SURPASS-CVOT)

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Lilly

Status and phase

Active, not recruiting
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Tirzepatide
Drug: Dulaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04255433
17073
I8F-MC-GPGN (Other Identifier)
2019-002735-28 (EudraCT Number)

Details and patient eligibility

About

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

Enrollment

13,299 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have a diagnosis of type 2 diabetes
  • Have confirmed atherosclerotic cardiovascular disease
  • HbA1c ≥7.0% to ≤10.5%
  • Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)

Exclusion criteria

  • Have had a major cardiovascular event within the last 60 days
  • Have type 1 diabetes mellitus
  • Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
  • Are currently planning treatment for diabetic retinopathy and/or macular edema
  • Currently planning a coronary, carotid, or peripheral artery revascularization
  • Have a history of pancreatitis
  • Have a history of ketoacidosis or hyperosmolar state/coma
  • Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
  • Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

13,299 participants in 2 patient groups

Tirzepatide
Experimental group
Description:
Tirzepatide administered subcutaneously (SC) once a week.
Treatment:
Drug: Tirzepatide
Dulaglutide
Active Comparator group
Description:
Dulaglutide administered SC once a week.
Treatment:
Drug: Dulaglutide

Trial contacts and locations

637

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Data sourced from clinicaltrials.gov

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