EUCTR2011-003818-16-DE进行中（未招募）不适用
A randomized, open-label, cross-over study to evaluate patient preferences for Eucreas® versus Victoza® as add-on to Metformin in Type 2 Diabetes mellitus patients who did not have adequate glycaemic control with metformin
ovartis Pharma GmbH0 个研究点开始时间: 2011年10月12日最近更新:
适应症
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 < 80 years at Visit 1.
- •2. Patients with a confirmed diagnosis of T2DM:
- •3. Patients treated with a stable dose of 1000mg Metformin bid for at least 12 weeks prior to Randomization (Visit 2)
- •4. Patients with a medical indication, as assessed by the investigator, which requires the expansion of the current anti diabetic therapy
- •5. HbA1c of = 6.5% and = 9.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled.
- •6. Body mass index (BMI) in the range of 19-35kg/m2 inclusive at Visit 1.
- •7. Agreement to maintain their current diet and exercise habits during the full course of the study.
- •8. Signed informed consent to participate in the study.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.FPG =270mg/dL (15.0 mmol/L) at Visit 1.
- •2.use of any of the following medications as assessed at Visit 1:
- •a.Prior use of DPP-4 inhibitors or GLP-1 analogues.
- •b.Prior use of insulin treatment (for =7 consecutive days) in the preceding 12 weeks.
- •c.Prior use of sulfonylurea (for =7 consecutive days) in the preceding 12 weeks.
- •d.Use of weight control products including weight-loss medications in the last 12 weeks.
- •e.Use of oral (=7 consecutive days) or chronic parenteral or intra-articular corticosteroid treatment within the last 8 weeks.
- •f.Treatment with growth hormone within the previous 6 months.
- •g.Treatment with any drug of known and frequent toxicity to a major organ, or that may interfere with the interpretation of the efficacy and safety data during the study.
- •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 (as defined by consumption of more than 24 units of alcohol per week) 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. Acute infections which may affect blood glucose control within the past 4 weeks.
- •m.Acute conditions with the potential to alter renal function within the past 6 months,
- •?dehydration
- •?severe infection
- •?intravascular administration of iodinated contrast agents
- •n.Acute or chronic inflammatory bowel diseases.
- •o.Acute or chronic diabetic gastroparesis
- •p.Acute or chronic Thyroid diseases
- •4. Any of the following significant laboratory abnormalities as assessed at Visit 1:
- •a.Clinically significant renal dysfunction: glomerular filtration rate (GFR) <60mL/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) at Visit 1, confirmed by repeat measure within 3 working days.
- •c.Total bilirubin > 2x ULN and/or direct bilirubin > 1x 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.
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