EUCTR2006-001843-74-IT进行中（未招募）不适用
A randomized, double-blind, parallel-group, placebo-controlled, dose-response, multicentre, multinational study evaluating the efficacy and safety of AVE2268 administered either twice daily breakfast and lunch at a dose of 300, 600 and 1200 mg or once daily breakfast at a dose of 1200 mg, in patients with type 2 diabetes treated with metformin and not adequately controlled - ND
Sanofi-Synthelabo Recherche0 个研究点目标入组 300 人开始时间: 2006年12月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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
- •Male or female patients aged 8805; 18 years and 75 years at screening. Type 2 diabetes mellitus, as defined by the American Diabetes Association, for at least one year at the time of screening Appendix A HbA1c measured at visit 1 in the range of 8805; 7.0 and or 9.0 ; Stable metformin treatment dose 8805; 1.5g/day for at least 3 months prior to enrollment in the study . No other antidiabetic medications are permitted for 3 months prior to enrollment Written informed consent/consents.
- •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
- •- Modification of metformin treatment within 3 months prior to screening visit. - BMI 40kg/m2 - Administration of other investigational drugs within 60 days prior to screening visit. -Presence of any clinically significant endocrine disease other than type 2 diabetes . Note euthyroid patients on replacement therapy can be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit - Diabetes other than type 2 diabetes - Subjects with brittle-diabetes or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis - Presence or history of cancer within the past five years with the exception of adequately treated localized basal skin cancer or in situ uterine cervical cancer - History or presence of pancreatitis - Evidence of clinically relevant uncontrolled hypertension - Evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization - Positive test for hepatitis B surface antigen and/or hepatitis C antibody - Impaired hepatic tests as shown but not limited to ALT, AST 3 x ULN, AP 2 x ULN and Bilirubin 1.5 x ULN If Bilirubin is 1.5 ULN, and all other liver parameters are within the limits described above, a measurement of direct and indirect Bilirubin will be done to diagnose a potential Gilbert s disease which will not be an exclusion criteria - Impaired renal function, as shown but not limited to creatinine clearance 50 ml/min predicted by using the Cockcroft-Gault formula - History of proteinuria 1g/24h or presence at screening of a protein creatinine ratio 0.7 g protein mmol creatinine in the absence of excessive exercise - Presence of urinary tract infection at screening - Presence of any clinically significant abnormality in blood or urinary laboratory tests performed at screening - Presence of any clinically significant abnormality on the ECG performed at the screening visit - Treatment with other antidiabetic agents including insulin other than metformin in the last 3 months before study entry - Prolonged use more than 10 days of systemic corticosteroids or if daily dosage 1000 956;g equivalent beclomethasone within the past 3 months or administration of systemic long-acting corticosteroids within the past 3 months or anticipated need for systemic glucocorticoids during the study -Thyroid replacement therapy if the dosage has been modified during the 3 months prior to screening visit. - Pregnant or breast-feeding women - Women of childbearing potential not protected by medically approved contraceptive method of birth control, or who are unwilling or unable to be tested for pregnancy. Pregnancy status should be checked by serum pregnancy testing prior to exposure to the investigational product and at the end of the study. - History or evidence of clinically relevant renal or urological disorder i.e. obstructive renal disease, prostatic disorder with significant impact on miction, primary glomerular diseases... , significant hematuria quantitatively assessed - History or presence of gastrointestinal disorder, i.e. chronic diarrhea, stomach/gastric surgery, irritable bowel syndrome
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