EUCTR2011-005405-78-DK进行中（未招募）1 期
Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes - AddHope2
Steen Bendix Haugaard0 个研究点目标入组 40 人开始时间: 2012年1月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •Stable CAD documented by either;
- •a)previous MI (a minimum of 6 weeks after acute MI)
- •b)previous coronary revascularization
- •c)CAD confirmed by an abnormal coronary arteriograph (CAG) or CT-angiography showing stenosis > 50% of any major coronary arteries.
- •Body mass index (BMI) >/= 25,0 kg/m2
- •Age from 18 to 85 years of age
- •Type 2 diabetes diagnosed either as:
- •a)HbA1c >/= 6.5% but b)HbA1c <6.5 % and fasting plasma glucose >/= 7.0 mmol/l (confirmed)
- •c)HbA1c <6.5 % and a 2 h plasma glucose value during OGTT >/= 11.1 mmol/l
- •The data for glucose metabolism are accepted provided that they have been obtained within 20 weeks before screening of the patient. The glucose metabolic categories are defined by ADA and WHO criteria
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Type 1 diabetes mellitus defined as C-peptide < 450 pM
- •Previously diagnosed diabetes mellitus before screening by OGTT except from previous gestational diabetes
- •Previous use of antidiabetic medication except from use during previous gestational diabetes. It is accepted that the patient has been treated with oral anti diabetic drugs (OAD) after diagnosis of T2D as long as the patient pause OAD at least 4 weeks before baseline measurements in this trial
- •Significant heart disease (NYHA > 2; Ejection Fraction < 40%, unstable angina pectoris, atrial fibrillation)
- •Liver disease (transaminases > x2 greater than upper normal level)
- •Renal diseases (eGFR < 50)
- •Any chronic medical condition to unduly increase risk for the potential enrollee as judge by study investigators
- •Anemia (<85% of lower normal limit), leucopenia (<85% of lower normal limit), or thrombocytopenia (< 85% of lower normal limit)
- •Pregnancy or failure to comply with contraceptional planning within two years, or breastfeeding
- •Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators
- •Use of immunosuppressive therapy in the preceding 12 months
- •Chronic pancreatitis / previous acute pancreatitis
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors, or other GLP-1 mimetics (Exenatide), which in the Investigator’s opinion could interfere with glucose metabolism
- •Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, which in the Investigator’s opinion could interfere with the results of the trail
- •Inflammatory bowel disease
- •Previous bowel resection
- •Clinical signs of diabetic gastroparesis
- •The receipt of any investigational product 90 days prior to this trial
- •Screening calcitonin = 50 ng/l
- •Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
- •Refusal to sign informed consent.
研究者
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