A Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3000

Inclusion Criteria

1. Patients with a diagnosis of T2D
2. Patients with HbA1c =6.5% at Screening.
3. High-risk group defined as males and females =40 years old with at least one documented occurrence of: CAD, cerebrovascular disease, or symptomatic peripheral arterial disease whose disease, in the Investigator's opinion, is stable, and not in the acute recovery stage of a CV event (i.e., event listed below to have occurred at LEAST 1 month prior to Screening, unless otherwise specified)
4. Low-risk group defined as males and females =60 years old with at least one other risk factor in addition to T2D
5. Current treatment with an intermediate-acting and / or long-acting insulin or intermediate and / or long-acting insulin analogue is allowed; if the screening HbA1c value is =8.0%, then the total daily dose of intermediate-acting and/or long-acting insulin or intermediate and/or long-acting insulin analogue will be reduced by 20% at randomization
6. Patients who are on a stable treatment regimen of diet and exercise alone or who are being treated with oral monotherapy or oral combination antidiabetic therapy with the exception of a dipeptidylpeptidase-4 (DPP-4) inhibitor or a glucagonlike peptide (GLP)-1 agonist , or sodium-glucose transporter-2 inhibitor (SGLT2 inhibitor).
7. Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception during the study
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 1500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1500

Exclusion Criteria

1. Prior treatment with DPP-4 inhibitor or GLP-1 agonist or SGLT2 inhibitors (e.g. canagliflozin) within 3 months prior to Screening
2. Current treatment with rapid-acting insulin or rapid-acting insulin analogues;
3. Requirement of treatment with immunosuppressants or medications that affect gastrointestinal (GI) motility (see Appendix B);
4. Diagnosis of or history of:
• Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acromegaly and Cushing's Syndrome;
• Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within 6 months prior to screening;
• Major hypoglycemia (defined as requiring third party assistance) within 1 month prior to Screening.
5. History of acute or chronic pancreatitis;
6. History of thyroidcancer, multiple endocrine neoplasia type 2 (MEN2) or a family history of medullary thyroid cancer or MEN2
7. Presence of a thyroid nodule detected on physical examination that
has not been fully evaluated;
8. Currently scheduled for cardiac surgery or arterial revascularization (carotid, coronary, or peripheral) procedures;
9. Current New York Heart Association (NYHA) Class III or IV heart failure;
10. Diagnosed and/or treated malignancy (except for treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years;
11. Uncontrolled hypertension at Screening defined as a systolic BP >180 mmHg and/or a sitting diastolic BP >100 mmHg (may be repeated after 15 minutes and exclusion based on last measurement);

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

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