EUCTR2012-005399-32-IT进行中（未招募）1 期
Randomized, open label, two parallel arms, intervention trial comparing the effect of DPP-IV inhibitor Vildagliptin vs. Glibenclamide on circulating EPCs. - Vildagliptin and EPC
AZIENDA OSPEDALIERA DI PARMA0 个研究点目标入组 100 人开始时间: 2013年1月11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
- 100
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. Age equal or above 35 years;
- •2. Diagnosis of type 2 diabetes mellitus as defined by the American Diabetes Association , with at least one year of disease duration at the time of the screening visit;
- •3. Blood glucose lowering treatment with Metformin alone (monotherapy) at a stable dose of at least 1.5 g/day (or maximum tolerated dose) in the 3 months prior to the screening visit;
- •4. Insufficient metabolic control as defined by recent (last six months) HbA1c = 7% in any peripheral laboratory and confirmed at the time of the screening;
- •5. Absence of a recent clinically-relevant progression of micro- and macro-vascular complications (see exclusion criteria);
- •6. Written informed consent to participate to the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Age below 35 years
- •2. Type 1 diabetes or other causes of diabetes (pancreatectomy, gestational diabetes, etc.)
- •3. HbA1c < 7% or = 9% at the screening visit
- •4. Treatment with any blood glucose lowering treatment other than Metformin in the six months before screening visit
- •5. BMI < 20 or = 40 kg/m2, or current/ past history of clinically-relevant eating disorders (including -but no limited to- nervous anorexia, bulimia, binge-eating disorders, etc.)
- •6. Significant progression of diabetic macro-angiopathy or cardiovascular disease in the six months prior to study visit, including:
- •- Acute myocardial infarction or acute coronary syndrome requiring hospitalization;
- •- Acute cerebro-vascular event requiring hospitalization;
- •- Acute limb ischemia or new onset of clinically-relevant peripheral artery disease (as defined by claudication + positive ABI test);
- •- New limb ulceration of suspected vascular origin or new onset of a diabetic foot or significant progression of pre-existing lesions;
- •- Any revascularization procedure (by-pass, stenting, angioplasty, trombo-endarterectomy, etc.) in any arterial district;
- •7. Significant progression of diabetic micro-angiopathy in the six months prior to study visit, including:
- •- Proliferative retinopathy, or progression of severity of more than one step, or new macular edema likely to be laser-treated. Steps of diabetic retinopathy: absent, background, mild non-proliferative, moderate-to-severe non-proliferative, proliferative;
- •- Increase of at least 0.5 mg/dL of plasma creatinine or progression to macro-proteinuria;
- •- Onset of clinically-relevant neuropathy
- •- Onset of erectile dysfunction
- •8. Organ failure or other severe diseases limiting life expectancy;
- •9. Beginning, in the three months before screening visit, of any kind of drug which can modify glicemic levels (beta-blockers, diuretics…), or acute disease (acute infection, urinary tract infection…) in three months before screening visit
- •10. History of inflammatory/infective/autoimmune chronic disease
- •11. History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, gastric surgery, inflammatory bowel disease;
- •12. Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at screening that in the judgment of the investigator would preclude safe completion of the study;
- •13. Uncontrolled or inadequately controlled hypertension at screening (SBP>190 or DBP >100 mmHg)
- •14. Ongoing pregnancy or absence of effective contraception in women with childbearing potential
- •15. Contraindications to the maintenance of the background therapy (Metformin), including –but not limited to- chronic kidney failure or plasma creatinine concentrations > 1.5 mg/dL, severe respiratory failure, etc.;
- •16. Contraindications to the use of a Sulfonylurea;
- •17. Contraindications to the use of a DPP-IV Inhibitor;
- •18. Laboratory findings, or other disease conditions, at the screening visit that might interfere with study measurements:
- •- Hemoglobinopathy known to affect HbA1c assays;
- •- Known chronic liver diseases, including HBV and HCV infection;
- •- Liver makers (AST, ALT, ALP, GGT, bilirubin) above 2 times the upper normal limit;
- •- Amylase and/or lipase above 2 times the upper normal limit;
- •19. Chronic use of systemic and/or inhaled corticosteroids (only topical corticosteroids are allowed);
- •20. History of low compliance, clinically-relevant psychiatric disorders or any current/ historical
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