Status and phase
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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
Sex
Ages
Volunteers
Inclusion criteria
Men or women at least 40 years old with a diagnosis of type 2 diabetes
Established cardiovascular disease, including at least 1 of the following:
Coronary artery disease (CAD) with any of the following:
Cerebrovascular disease - any of the following:
Peripheral arterial disease with either of the following:
Note: Supporting medical documentation is required in all instances
HbA1c ≥7% (≥53 mmol/mol) and ≤10.5% (≤91.3 mmol/mol) based on central laboratory assessment at screening
Body mass index (BMI) ≥25 kg/m2
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.
Male patients: Men, regardless of their fertility status, with nonpregnant women of childbearing potential (WOCBP) partners must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms, as well as 1 additional highly effective (less than 1% failure rate) method of contraception (such as combination oral contraceptives, implanted contraceptives, or intrauterine devices) or effective method of contraception (such as diaphragms with spermicide or cervical sponges) for the duration of the study and until their plasma concentrations are below the level that could result in a relevant potential exposure to a possible fetus, predicted to be 90 days following the last dose of study drug.
Men with pregnant partners should use condoms during intercourse for the duration of the study and until the end of the estimated relevant potential exposure in WOCBP (90 days). Men should refrain from sperm donation for the duration of the study and until their plasma concentrations are below the level that could result in a relevant potential exposure to a possible fetus, predicted to be 90 days following the last dose of study drug. Men who are in exclusively same-sex relationships (as their preferred and usual lifestyle) are not required to use contraception.
Female patients: Women of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with males. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception. Otherwise, WOCBP participating must agree to use 2 forms of effective contraception, where at least 1 form is highly effective (less than 1% failure rate), for the entirety of the study. Contraception must continue following completion of study drug administration for the entirety of the study and for 30 days thereafter.
Women not of childbearing potential may participate and include those who are:
In the investigator's opinion, are well motivated, capable, and willing to:
Capable of giving signed informed consent
Exclusion criteria
Have type 1 diabetes mellitus
Have uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at screening or randomization, in the judgment of the 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
Are currently planning treatment for diabetic retinopathy and/or macular edema.
Have been hospitalized for congestive heart failure (CHF) within 2 months prior to screening
Have chronic New York 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
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 or chronic hepatitis, signs or symptoms of any other liver disease, an alanine aminotransferase (ALT) level ≥3 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory (Note: Patients with nonalcoholic fatty liver disease are eligible to participate if their ALT level is <3 times the ULN for the reference range)
Have known chronic severe renal failure (defined as a known estimated glomerular filtration rate (eGFR) <15 mL/minute/1.73 m2) or are on chronic dialysis
Have evidence of a significant, uncontrolled endocrine abnormality (eg, thyrotoxicosis or adrenal crises)
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
Have a serum calcitonin level at screening of: (based on central laboratory results)
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
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
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 glucagon-like peptide-1 (GLP-1) receptor agonist (RA)
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
Have had coronary artery bypass graft surgery less than 5 years prior to screening
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
Treatment with GLP-1 RA or pramlintide, in a period of 3 months prior to Visit 1
Discontinuation of GLP-1 RA or pramlintide, due to intolerability any time prior to Visit 1
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
Primary purpose
Allocation
Interventional model
Masking
13,299 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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