The Effect of the drug Tirzepatide compared with the drug Dulaglutide on the Cardiovascular Risk in Patients with Type 2 Diabetes
- Conditions
- Type 2 diabetes mellitusMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2019-002735-28-IT
- Lead Sponsor
- ELI LILLY & COMPANY, LILLY CORPORATE CENTER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 12500
[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 (eg, 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6250
Have type 1 diabetes mellitus
Have uncontrolled diabetes requiring immediate therapy (eg. diabetic ketoacidosis) at screening or randomization, in judgment of physician.
Have had 1 or more events of severe hypoglycemia and/or 1 or more events of hypoglycemia unawareness within 6 months prior to screening.
[11] Are currently planning treatment for diabetic retinopathy and/or
macular edema.
Have been hospitalized for CHF within 2 months prior to screening.
Have chronic NY Heart Association Functional Classification IV CHF.
Are currently planning a coronary, carotid, or peripheral artery revascularization.
Had chronic or acute pancreatitis any time prior to screening, irrespective of etiology.
[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.
Have acute/chronic hepatitis, signs/symptoms of other liver disease, or an ALT level =3X the upper limit of normal (ULN) for reference range determined by central laboratory.
Known chronic severe renal failure (defined as a known eGFR <15 mL/minute/1.73 m2) or are on chronic dialysis.
Have evidence of significant, uncontrolled endocrine abnormality (thyrotoxicosis or adrenal crises).
Have family or personal history of MEN2 or familial medullary thyroid carcinoma (MTC) or personal history of nonfamilial MTC.
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.
History of active/untreated malignancy or in remission from clinically significant malignancy for less than 5 years. An exception for this criterion is basal/squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer.
History of 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.
Have had a transplanted organ (corneal transplants [keratoplasty] allowed) or awaiting an organ transplant.
Have any other condition (eg, hypersensitivity) that is a contraindication to any incretin or GLP-1 RAs.
Have had an MI, surgical or 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.
[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 deleted.
Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Have participated within the last 30 days in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
Have previously completed or withdrawn from this study or randomized into any other study investigating tirzepatide.
[36] Any women who are pregnant or breastfeeding.
[37] Have had a blood transfusion or severe blood loss within 90 days
prior to
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method