EUCTR2012-001143-46-DE进行中（未招募）不适用
A randomized open-label study to compare safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy
ovartis Pharma GmbH0 个研究点开始时间: 2012年4月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Age > 18 and < 85 years
- •2.Written informed consent must be obtained before any assessment is performed.
- •3.Confirmed diagnosis of T2DM.
- •4.Contraindicated or intolerant to take metformin.
- •5.HbA1c of = 7.0% and = 8.5% as determined by a central laboratory at Visit 1 and judged by the investigator to be inadequately controlled that requires the expansion of the current anti diabetic therapy.
- •6.Patients treated with any SU for at least the prior 12 weeks including a stable dose of glimepiride of 4mg (or if not tolerated, the maximal tolerated dose up to 4mg) for at least 4 weeks prior to Visit 1.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.
- •2.Use of any prohibited medication as per protocol section 6.6.
- •3.A history or evidence of any of the following:
- •a.Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state (including diabetic precoma or coma) within the past 6 months.
- •b.Current diagnosis of congestive heart failure (NYHA III or IV).
- •c.Myocardial infarction within the past 6 months.
- •d.Coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months
- •e.Stroke, transient ischemic attack, or reversible ischemic neurologic deficit within the past 6 months.
- •f.Unstable angina within the past 3 months.
- •g.Sustained and clinically relevant ventricular arrhythmia (patients with premature ventricular contractions if deemed not clinically significant may be enrolled).
- •h.Active substance abuse, alcohol abuse and history of alcohol-related diseases within the past 2 years.
- •i.Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing’s syndrome or acromegaly-associated diabetes).
- •j.Malignancy of an organ system (other than localized basal cell carcinoma of the skin) treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •k.hepatic disorder defined as:
- •Acute or chronic liver disease, evidence of hepatitis, cirrhosis or portal hypertension.
- •History of imaging abnormalities that suggest liver disease (except hepatic steatosis), such as portal hypertension, capsule scalloping, cirrhosis.
- •l. Evidence of active pancreatitis within the 1 month prior to baseline assessment
- •4.Any of the following significant laboratory abnormalities as assessed at Visit 1:
- •a.Clinically significant renal dysfunction: glomerular filtration rate (GFR) <30mL/min/1.73m2 (via modification of diet in renal disease (MDRD) formula).
- •b.alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3x upper limit of normal (ULN), confirmed by repeat measure within 3 working days.
- •c.Total bilirubin (except patients with Gilbert`s disease) > 2x ULN, confirmed by repeat measure within 3 working days.
- •d.Clinically significant laboratory abnormalities which, in the opinion of the investigator, cause the patient to be considered inappropriate for inclusion in the study.
- •5.Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
- •6.Patients who do not agree to take the study medication and do not want to follow the procedure as required by the study protocol.
- •7.Patients taking the SU component for longer than 5 years before Visit 1.
- •8.BMI < 21 or > 45 kg/m2 at Visit 1.
- •9.Donation of blood (500ml) or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period.
- •10.Potentially unreliable, inability to comply with the study procedures or medications, and/or judged by the investigator to be unsuitable for the study.
- •11.Use of an investigative drug within 30 days or 5 half-lives of the drug, whichever is longer.
- •12.History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •13.Study personnel or first de
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