PER-117-06已完成未知
A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2007年4月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1 - Men, women who are not fertile or have the potential to procreate who are using a medically approved method of birth control.
- •2- Age in the range of 18-78 years.
- •3- Patients with T2DM who have taken 850-1000 mg of daily dose of metformin as monotherapy for at least 2 months immediately before the visit 1.
- •4- Diagnosis of T2DM at least 2 months before entering the study (visit 1).
- •5- Body mass index (BMI) in the range of 22-45 kg / m2 at visit 1.
- •6- HbA1C in the range of 6.5-9.0% at visit 1.
- •7- FPG <270 mg / dL (15 mmol / L) at visit 1.
- •8- Written informed consent to participate in the study.
- •9- Ability to meet all the requirements of the study.
排除标准
- •1. Pregnant or lactating woman.
- •2. History of: Type 1 diabetes, diabetes resulting from liver damage, or secondary forms of diabetes.
- •3. Evidence of significant diabetic complications.
- •4. Acute infections that may affect the control of blood glucose within 4 weeks prior to visit 1 and another concomitant medical condition that may interfere with the interpretation of efficacy and safety during the study.
- •5. Any of the following within the last 6 months: myocardial infarction (MI), coronary artery bypass surgery or percutaneous coronary intervention, unstable angina or cerebrovascular accident.
- •6. Congestive heart failure (CHF) that requires pharmacological treatment.
- •7. Any of the following ECG abnormalities: Torsade de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second-degree AV block (Mobitz 1 and 2), third-degree AV block, prolonged QTc.
- •8. Malignancy including leukemia and lymphoma during the past 5 years.
- •9. Liver disease such as cirrhosis or active chronic hepatitis.
- •10. Contraindications and warnings according to the country-specific label for metformin that are not found in the other exclusion criteria.
- •11. Chronic treatment with insulin within the last 6 months.
- •12. Treatment with other oral antidiabetic agents within 3 months prior to the visit 1.
- •13. Chronic oral or parenteral treatment within 8 weeks prior to visit 1.
- •14. Treatment with growth hormone or similar drugs.
- •15. Treatment with antiarrhythmics of classes la. Ib and lc or III.
- •16. Use of other investigational drugs on visit 1, or within 30 days or 5 half-lives for visit 1, whichever is longer.
- •17. Treatment with any drug with a known frequent toxicity to important organ systems within the last 3 months.
- •18. Any of the following significant laboratory abnormalities: ALT, AST greater than 3 times the upper limit at visit 1. Direct bilirubin greater than 1.3 times the upper limit at visit 1; clinically significant renal failure; clinically significant values of TSH at visit 1; clinically significant laboratory abnormalities, confirmed by repeated measurements in addition to hyperglycemia, hyperinsulinemia and glycosuria at visit 1; fasting triglycerides> 700 mg / dL at visit 1.
- •19. History of abuse of active substance within the last 2 years.
- •20. Participation in previous studies with vildagliptin.
研究者
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