The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)
- Conditions
- 'Adverse Events relating to the Heart and Blood Vessels in Patients with Type 2 Diabetes' and 'Cardiovascular Events in Patients with Type 2 Diabetes'10012653
- Registration Number
- NL-OMON52730
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 336
[1] Men or women at least 40 years old with a diagnosis of T2DM (WHO 2019).
[2] Established CVD, including at least 1 of the following (a-c):
a. Coronary artery disease (CAD) with EITHER of the following:
- Documented history of spontaneous MI
- >=50% stenosis in 1 or more major coronary arteries, determined by invasive
angiography
- >=50% stenosis in 2 or more major coronary arteries, determined by computed
tomography coronary angiography (CTCA), or
- History of surgical or percutaneous coronary revascularization procedure;
b. Cerebrovascular disease - ANY of the following:
- Documented history of ischemic stroke
- Carotid arterial disease with >=50% stenosis, documented by carotid
ultrasound, magnetic resonance imaging (MRI), or angiography
- Carotid stenting or surgical revascularization;
c. Peripheral arterial disease with EITHER of the following:
- Intermittent claudication and ankle-brachial index <0.9
- Prior nontraumatic amputation or peripheral vascular procedure (e.g.,
stenting or surgical revascularization), due to peripheral arterial ischemia.
[3] HbA1c >=7% (>=53 mmol/mol) and <=10.5% (<=91.3 mmol/mol) based on central
laboratory assessment at screening.
[4] Body mass index (BMI) >=25 kg/m2.
[5] At the time of signing the informed consent: Contraceptive use by men or
women should be consistent with local regulations regarding the methods of
contraception for those participating in clinical trials.
[6] In the investigator*s opinion, patients are well motivated, capable, and
willing to learn how to self-inject treatment (tirzepatide or dulaglutide), as
required for this protocol (visually impaired persons and/or persons with
physical limitations who are not able to perform the injections must have the
assistance of an individual trained to inject the study drug).
[7] Patients are capable of giving signed informed consent.
[8] Have type 1 diabetes mellitus.
[9] Have uncontrolled diabetes requiring immediate therapy (such as diabetic
ketoacidosis) at screening or randomization, in the judgment of the physician.
[10] Have had 1 or more events of severe hypoglycaemia and/or 1 or more events
of hypoglycaemia unawareness within 6 months prior to screening.
[11] Are currently planning treatment for diabetic retinopathy and/or macular
oedema.
[12] Have been hospitalized for CHF within 2 months prior to screening.
[13] Have chronic New York Heart Association Functional Classification IV CHF.
[14] Are currently planning a coronary, carotid, or peripheral artery
revascularization.
[15] Had chronic or acute pancreatitis any time prior to screening,
irrespective of aetiology.
[16] Have a known clinically significant gastric emptying abnormality such as
severe gastroparesis or gastric outlet obstruction, or have undergone or
currently planning any gastric bypass (bariatric) surgery or restrictive
bariatric surgery
[17] Have acute or chronic hepatitis, signs or symptoms of any other liver
disease, or an alanine aminotransferase (ALT) level >=3X the upper limit of
normal (ULN) for the reference range, as determined by the central laboratory.
[18] Have known chronic severe renal failure (defined as a known eGFR <15
mL/minute/1.73 m2) or are on chronic dialysis.
[19] Have evidence of a significant, uncontrolled endocrine abnormality (eg,
thyrotoxicosis or adrenal crises).
[20] Have a family or personal history of multiple endocrine neoplasia type 2
(MEN2) or familial medullary thyroid carcinoma (MTC) or personal history of
nonfamilial MTC.
[21] Have a serum calcitonin level at screening of: (based on central
laboratory results)
- >=20 ng/L at Visit 1, if eGFR >=60 mL/min/1.73 m2, or
- >=35 ng/L at Visit 1, if eGFR <60 mL/min/1.73 m2.
[22] Have a history of an active or untreated malignancy or are in remission
from a clinically significant malignancy for less than 5 years. An exception
for this criterion is basal or squamous cell skin cancer, in situ carcinomas of
the cervix, or in situ prostate cancer.
[23] Have a history of any other condition (such as known drug or alcohol abuse
or psychiatric disorder) that, in the opinion of the investigator, may preclude
the patient from following and completing the protocol.
[24] Have had a transplanted organ (corneal transplants [keratoplasty] allowed)
or awaiting an organ transplant.
[25] Have any other condition (eg, hypersensitivity) that is a contraindication
to any incretin or GLP-1 RAs.
[26] Have had an MI, percutaneous coronary revascularization procedure,
ischemic stroke, carotid stenting or surgical revascularization, nontraumatic
amputation, or peripheral vascular procedure (eg, stenting or surgical
revascularization) less than 60 days prior to screening
[27] Have had coronary artery bypass graft surgery less than 5 years prior to
Screening.
[37] Have had a blood transfusion or severe blood loss within 90 days prior to
screening or have known haematological conditions that may interfere with HbA1c
measurement.
[28] Treatment with GLP-1 RA or pramlintide, in a period of 3 months prior to
Visit 1
[29] Discontinuation of GLP-1 RA or pramlintide, due to intolerability any time
prior to Visit 1
[30] Exclusion Criterion [30] has been
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to first occurrence of a component event of a MACE-3.</p><br>
- Secondary Outcome Measures
Name Time Method