EUCTR2009-014986-22-HU进行中（未招募）不适用
A randomized double blind, placebo-controlled clinical trial to assess the effects of taspoglutide (RO5073031) on cardiovascular outcomes in subjects with inadequately controlled type 2 diabetes and established cardiovascular disease - EMERGE 8
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
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. Men and women > 18 years old at screening. Women of childbearing potential will be required to use two approved birth control methods during the entire course of the study.
- •2. Known type 2 diabetes (T2D) or newly diagnosed T2D according to the 1997 American Diabetes Association diagnostic criteria*
- •*Fasting plasma glucose (FPG) values =126 mg/dl, or symptomatic hyperglycemia and a casual glucose =200 mg/dl OR 2-h plasma glucose =200 mg/dl after a 75 g oral glucose load
- •Diabetes may be managed with diet alone, or with any approved glucose-lowering therapies except for those listed in exclusion criteria 11 and 12. The diabetes reatment will follow the local usual standard of care
- •3. HbA1C =6.5% and =10% at screening
- •4. Body mass index (BMI) = 23 kg/m2 at screening
- •5. Subjects with established cardiovascular (CV) disease with onset =1 month prior to screening and who are stable in the Investigator’s judgment, based on the presence of at least one of the following:
- •Documented coronary disease:
- •Myocardial infarction
- •History of coronary revascularization (percutaneous coronary interventions, coronary artery bypass graft surgery - CABG)
- •Documented angina pectoris with ischemic ECG changes at rest or with ischemic ECG changes on a graded exercise test, or positive cardiac imaging stress test results documenting ischemia
- •Angiographic or CT-imaging (e.g. MDCT/CTA) evidence of = 70% narrowing of one coronary artery or = 50% narrowing of two or more coronary arteries
- •Documented cerebrovascular disease:
- •History of stroke (TIA is not fulfilling this inclusion criterion)
- •Angiographic evidence of at least 75% narrowing of one or more carotid arteries
- •History of arterial revascularization Documented symptomatic peripheral arterial disease:
- •Current intermittent claudication and ankle-brachial index =0.85 and/or documented peripheral artery disease
- •History of intermittent claudication and previous intervention (peripheral bypass, angioplasty)
- •6. Ability and willingness to give written informed consent and to comply with the requirements of 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Women who are currently pregnant, currently lactating, or intent to become pregnant during the study period.
- •2. Diagnosis of or history of:
- •a. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acromegaly and Cushing’s Syndrome
- •b. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
- •c. Severe hypoglycemia (defined as requiring third party assistance) within one month prior to screening
- •3. Clinically significant gastrointestinal (GI) disease, judged likely to limit tolerability of taspoglutide, such as inflammatory bowel disease, celiac disease, diabetic
- •gastroparesis, cholelithiasis
- •4. History of bariatric surgery (e.g. gastric bypass or antrectomy), small or large bowel resection, or laparoscopic gastric banding, or intent to undergo any similar procedure during the study period
- •5. History of chronic pancreatitis or acute pancreatitis.
- •6. Family or personal history of medullary thyroid carcinoma.
- •7. Currently scheduled for cardiac surgery or arterial revascularization (carotid, coronary or peripheral) procedures
- •8. Current NYHA class IV heart failure or post-transplantation cardiomyopathy
- •9. 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
- •10. Any concurrent medical condition/disorder that, in the opinion of the Investigator, is likely to:
- •- Interfere with the subject’s ability to complete the entire study period or to participate in all aspects of the trial
- •- Require the administration during the study of a treatment that would affect the interpretation of the efficacy and safety variables
- •11. Current treatment or known intolerance to exenatide or exendin-4 analogues, GLP-1 or GLP-1 analogues
- •12. Current treatment with insulin or insulin analogues
- •13. Treatment with systemic (oral or parenteral) corticosteroids for more than 7 consecutive days within 12 weeks prior to screening
- •14. Use of any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening unless local health authority guidelines mandate a longer period
- •15. Any of the following laboratory abnormalities at screening:
- •a. ALT or AST > 3 times the upper limit of the normal range
- •b. Fasting triglycerides > 5.6 mmol/L (> 500 mg/dL)
- •16. Glomerular filtration rate (GFR) <30 mL/min/1.73m2 estimated by the Modification of Diet in Renal Disease (MDRD) equation: GFR (mL/min/1.73 m2) = 186 x
- •(serumcr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African-American) (Please see the following web-based GFR calculator: http://www.nkdep.nih.gov/professionals/gfr_calculators/orig_con.htm)
- •17. Systolic blood pressure (SBP) = 180 or diastolic blood pressure (DBP) = 110 mmHg at screening
- •18. Potentially unreliable subjects and those judged by the Investigator to be unsuitable for the study
- •19. History of active substance abuse (including alcohol) within the past 2 years
研究者
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