EUCTR2012-002219-25-FI进行中（未招募）不适用
A Randomized, Multicenter Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 within 12 weeks of randomization.
- •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 2000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2000
排除标准
- •1. Prior treatment with DPP-4 inhibitor or GLP-1 agonist within 12 weeks of randomization;
- •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. Family or personal history of thyroid carcinoma or multiple endocrine neoplasia type 2 (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 basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years;
- •11. Uncontrolled hypertension at Screening defined as a sitting systolic BP >180 mmHg and/or a sitting diastolic BP >100 mmHg (may be repeated after 15 minutes and exclusion based on last measurement);
研究者
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