EUCTR2008-005012-41-CZ进行中（未招募）不适用
A multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of 52 weeks treatment with vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 246
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 must give written informed consent before any assessment is performed.
- •2. Patients 18-85 years old (inclusive) at Visit 1.
- •3. Patients with T2DM, diagnosed at least 3 months prior to Visit 1, either untreated (defined as not taking anti-diabetic therapy for at least 8 weeks prior to Visit 1) or treated with anti-diabetic therapy (defined as sulfonylurea, insulin, alpha-glucosidase inhibitors, or glinides as monotherapy or combination therapy for at least 8 weeks prior to Visit 1) and maintaining dietary advice and exercise habits during the full course of the study.
- •4. Stable dose of anti-diabetic therapy over the past 4 weeks prior to Visit 1 (stable insulin therapy is defined as ± 20% of total daily units) for patients on anti-diabetic treatment.
- •5. CHF (NYHA Class I, Class II, or Class III) at Visit 1.
- •Treatment of heart failure should be according to local/national guidelines; beta-blockers are allowed unless specifically contraindicated.
- •6. LVEF < 40% (results must be available at Visit 2, prior to randomization)
- •7. HbA1c in the range of = 6.5% to 10% at Visit 1.
- •8. Body Mass Index (BMI) in the range of 22-42 kg/m2, inclusive, at Visit 1.
- •For detailed inclusion criteria, please refer to the full protocol.
- •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. Fasting Plasma Glucose (FPG) = 270 mg/dL (15 mmol/L) at Visit 1.
- •2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
- •3. A history of:
- •type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing’s syndrome and acromegaly.
- •acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
- •4. Patients that have been enrolled in a vildagliptin clinical trial or taken other DPP-4 inhibitor, GLP-1 mimetics (e.g. exenatide), GLP-1 analogues (e.g. liraglutide) studies within 6 months prior to visit 1.
- •5. Patients taking vildagliptin at any time.
- •6. Patients taking thiazolidinediones (TZDs). TZDs given up to 12 months prior to Visit 1 are allowed.
- •7. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study
- •8. Any of the following within the past 6 months:
- •myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor);
- •coronary artery bypass surgery or percutaneous coronary intervention
- •unstable angina
- •9. Any of the following ECG abnormalities:
- •Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation
- •second degree AV block (Mobitz 1 and 2); patients with pacemakers are not excluded.
- •third degree AV block; patients with pacemakers are not excluded.
- •prolonged QTc (> 500 ms)
- •10. GFR (estimated by Cockcroft-Gault formula) < 30 mL/min at Visit 1.
- •For detailed exclusion criteria, please refer to the full protocol.
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