EUCTR2008-001246-21-PL进行中（未招募）不适用
A multicenter, double-blind, randomized study to compare the efficacy of 24 weeks treatment with fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) versus metformin monotherapy (1000 mg bid) in patients with type 2 diabetes inadequately controlled with metformin monotherapy
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
- 300
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. Male, non-fertile female or female of childbearing potential using a medically approved birth control method, based on local regulations (defined in full protocol)
- •2. Patients with T2DM who have received metformin for at least three months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1. If patients are currently treated with their maximum tolerated dose of metformin but it is < 2000 mg daily, the patients are not eligible for screening. Patients treated with < 2000 mg who have not been previously titrated to a higher dose will start metformin 2000 mg daily at visit 1; if the higher dose is not tolerated, the patients will not be eligible for randomization. Patients receiving a daily dose of metformin > 2000 mg at visit 1 are not eligible.
- •3. Age in the range of 18-78 years inclusive.
- •4. Body mass index (BMI) in the range of 22-40 kg/m2 inclusive at visit 1.
- •5. HbA1c in the range of 7.0 to 9.5% inclusive at visit 1.
- •6. FPG < 260 mg/dL (14.4 mmol/L) at visit 1.
- •7. Agreement to maintain prior diet and exercise habits during the full course of the study.
- •8. Written informed consent to participate in the study and ability to comply with all study requirements.
- •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. Pregnant or lactating female.
- •2. 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.
- •3. Patients taking vildagliptin, other DPP-4 inhibitors, GLP-1 mimetics (e.g. exenatide),
- •GLP-1 analogues (e.g. liraglutide) within six months prior to visit 1 whether in a clinical trial or as marketed product.
- •4. 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.
- •5. 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 clinical trial at the discretion of the investigator and/or local medical monitor);
- •unstable angina
- •coronary artery bypass surgery or percutaneous coronary intervention;
- •6. Congestive heart failure requiring pharmacologic treatment.
- •7. Any of the following ECG abnormalities:
- •Uncontrolled second (Mobitz 1 and 2) or third degree AV block (patients with
- •pacemakers that control the AV blocks are eligible)
- •prolonged QTc (> 500 ms)
- •Torsades de pointes, sustained and clinically relevant ventricular tachycardia or
- •ventricular fibrillation
- •8. Malignancy including leukemia and lymphoma (not including basal cell skin cancer)
- •within the last 5 years.
- •9. Liver disease such as cirrhosis or chronic active hepatitis B and C.
- •10. Acromegaly or treatment with growth hormone or similar drugs.
- •For a full list of the exclusion criteria, please refer to the full protocol.
研究者
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