EUCTR2010-021097-11-HU进行中（未招募）不适用
A multi-center, randomized, double-blind placebo controlled study to evaluate the efficacy and safety of 24 weeks treatment with vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with type 2 diabetes
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
- 290
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
- •Confirmed diagnosis of T2DM by standard criteria.
- •Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (= 1500 mg) as monotherapy and in combination with SU, TZDs, and glinides at visit 1 with:
- •Monotherapy HbA1c = 8.5 and = 11.0%
- •Dual therapy HbA1c = 7.5% and = 11.0%
- •Age: =18 to = 78years at Visit 1.
- •HbA1c of = 7.5 and = 11.0% at Visit 105,
- •Body Mass Index (BMI) =22 to =45 kg/m2 at Visit 1.
- •Patients not already treated with glimepiride must be willing to switch to that drug.
- •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
- •FPG = 270 mg/dL (= 15.0 mmol/L) at Visit 1 and at Visit 105 (Week -1).
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •Use of weight control products including weight-loss medications
- •DPP-4 inhibitors, GLP-1 analogues/mimetics or insulin within the previous 6 months
- •Chronic oral (>7 consecutive days), parenteral or intra-articular corticosteroid treatment within 8 weeks
- •Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g., Cushing’s syndrome or acromegaly-associated diabetes).
- •Hepatic disorders
- •Clinically significant renal dysfunction
- •Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Visit 1 or Visit 105 (Week -1), confirmed by repeat measure within 3 working days
- •Total bilirubin > 2 x ULN and/or direct bilirubin > ULN at Visit 1 or Visit 105 (Visit -1), confirmed by repeat measure within 3 working days
- •Positive Hepatitis B surface antigen (HbsAg) at Visit 1
- •Positive Hepatitis C antibody test (anti-HCV) at Visit 1
研究者
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