EUCTR2005-005141-19-DE进行中（未招募）不适用
A 12-week, multicenter, double blind, placebo-controlled, randomized study of the efficacy and safety of 1.0 mg AVE8134 tablets for reducing A1c in the treatment of patients with confirmed type 2 diabetes mellitus who are not on current drug therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
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. Men or women, > or =18 years of age who have confirmed type 2 diabetes mellitus as established in the medical history (i.e. diagnosed before the screening visit) and have either previously not been treated or are currently not on drug therapy;
- •2. A1c > or = 7. 0 % and < or = 10. 0 % at screening visit;
- •3. Fasted plasma glucose between 126 – 250 mg/dl, measured at screening visit;
- •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.Diabetes other than type 2 diabetes mellitus;
- •2.Treatment with any anti-diabetic oral agent and/or insulin within 2 months (8 weeks) prior to screening visit 1 (because of potential to bias the primary evaluation);
- •3.Likelihood of requiring treatment during the study period with glucose lowering drugs and/or insulin (because of potential to bias the primary evaluation);
- •4.Refusal or inability to give informed consents to participate in the study;
- •5.Inability and unwillingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter at home and subject diary;
- •6.Positive glutamic acid decarboxylase (GAD) antibody prior to screening visit 1 (in order to exclude LADA) ;
- •7.Patients receiving drugs not permitted by the study protocol (because of potential to bias the primary evaluation; for details see section 8.9 of the protocol)
- •-Fibrates, ezetimibe, nicotinic acid derivatives;
- •8.Creatine-kinase elevation of more than 2x ULN at visit 1 or two successive unexplained values above the upper limit of normal (ULN). Testing must be repeated within the screening period for values between 1 and 2x ULN;
- •9.Impaired hepatic function, as shown by but not limited to alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3x the ULN for gender/age measured at visit 1 (because of the current level of knowledge of metabolism and excretion). Testing can be repeated within the screening period for values greater than 3x ULN but < or = 5x ULN ;
- •10.Impaired renal function (because of the current level of knowledge of metabolism and excretion): Either shown by serum creatinine above the upper limit for gender/age, or creatinine clearance < 50 ml/min (calculated by the Cockroft-Gault formula) measured at visit 1;
- •11.History or presence of congestive heart failure NYHA II – IV (see Appendix B of the protocol);
- •12.History or presence of hyperthyroidism;
- •13.Clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult and would, in the opinion of the investigator, preclude the safe participation of the subject in this protocol;
- •14.History or presence of diabetic retinopathy;
- •15.Patients known to have positive test for hepatitis B surface antigen and/or hepatitis C antibody, or HIV;
- •16.Treatment with any investigational drug or placebo in the last month (30 days) before screening visit;
- •17.History of drug or alcohol abuse;
- •18.Subjects unlikely to comply with protocol, e.g. an inability and unwillingness to participate in adequate training, an uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study;
- •19.Subjects who have previously been treated with AVE8134;
- •20.Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol;
- •21.Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study;
- •22.Pregnancy (Pregnancy status must be checked by urine pregnancy testing prior to exposure to the investigational product);
- •23.Patients unable or unwilling to practice effective contraception;
- •24.Breast-feeding.
研究者
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