EUCTR2012-002219-25-ES进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
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. Patients with understanding of the study procedures and agreement to participate in the study by giving written informed consent in accordance with local regulations and the Institutional Review Board (IRB)/Ethics Committee (EC) governing the study site at or prior to Screening;
- •6. 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
- •7. 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
- •8.Calcitonin <50 pg/mL (ng/L) at Screening;
- •9. Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception during the study and for one additional menstrual cycle following the End-of-Treatment (ET) Visit.
- •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
排除标准
- •1. Prior treatment with DPP-4 inhibitor or GLP-1 agonist 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 (GI) motility (see Appendix B); 4. Allergic reactions or intolerance to GLP-1 receptor agonists; 5. History of hypersensitivity to exenatide;6. Diagnosis of or history of: Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes, Acute metabolic diabetic complications, major hypoglycemia; 7. History of acute or chronic pancreatitis; 8. Family or personal history of thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2); 9. Presence of a thyroid nodule detected on physical examination that has not been fully evaluated; 10. Thyroid-stimulating hormone (TSH) outside of normal limits at Screening. 11. Thyroid hormone therapy that has not been stable for ?6 weeks prior to Screening; 12. Currently scheduled for cardiac surgery or arterial revascularization (carotid, coronary, or peripheral) procedures; 13. Current New York Heart Association (NYHA) Class III or IV heart failure; 14. 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; 15. Prior history of treatment with an investigational drug within 30 days prior to Screening Visit 1 (Days -28 to -2) or 5 half lives (whichever is longer); participation in a clinical study involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study; 16. Laboratory abnormalities in FPG, ALT, AST, Bilirubin, Fasting triglycerides, GFR described in protocol. Patients taking metformin are excluded if serum creatinine levels are >1.5 mg/dL (132 µmol/L) for males, or >1.4 mg/dL (123 µmol/L) for females; 17. Uncontrolled hypertension at Screening defined as a systolic BP >180 mmHg and/or a diastolic BP >100 mmHg with or without antihypertensive medication (may be repeated after 15 minutes and exclusion based on last measurement); 18. History of positive serologic evidence of current infectious liver disease; 19. Presence of diabetic complications that, in the opinion of the Investigator, would complicate the patient?s participation in the study; 20.History of organ transplantation; 21. Known clinically significant gastric emptying abnormality (see Appendix B); 22. Donation of one unit (500 mL) or more of blood; significant blood loss equaling at least one unit of blood; or transfusion within 8 weeks prior to Screening;23. History or evidence of immunocompromised status; 24. History of active alcohol or substance abuse within 1 year prior to Screening; 25. Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to Screening; intra-nasal, intra-articular, intra-ocular, inhaled or topical steroids are permitted.
研究者
相似试验
进行中（未招募）
1 期
A Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 DiabetesEUCTR2012-002219-25-BGIntarcia Therapeutics, Inc.4,000
进行中（未招募）
不适用
A Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 DiabetesType 2 diabetesMedDRA version: 18.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-002219-25-FIIntarcia Therapeutics, Inc.4,000
进行中（未招募）
不适用
A Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 DiabetesType 2 diabetesMedDRA version: 16.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-002219-25-EEIntarcia Therapeutics, Inc.3,000
进行中（未招募）
1 期
A Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 DiabetesType 2 diabetesMedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-002219-25-SKIntarcia Therapeutics, Inc.4,000
进行中（未招募）
1 期
A Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 DiabetesType 2 diabetesMedDRA version: 18.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-002219-25-DEIntarcia Therapeutics, Inc.4,000