EUCTR2011-000518-21-DE进行中（未招募）不适用
Cross-over study to assess the difference in fasting plasma glucose (FPG) between vildagliptin (Galvus®/Eucreas®) and sitagliptin (Januvia®/Janumet®) after two weeks (FPG-VISIT) - FPG-VISIT
ovartis Pharma GmbH0 个研究点开始时间: 2011年4月8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.Type 2 diabetic patients stabilized on metformin monotherapy (stable dose for at least 4 weeks prior to Screening) = 1000 mg/day and = 2000 mg/day.
- •2.Patients must be diagnosed with type 2 diabetes mellitus at least 3 months prior to screening.
- •3.HbA1c 7.0 – 9.5% (metformin = 1000 mg/day and < 2000 mg/day) or
- •HbA1c 6.5 – 9.5% (metformin 2000 mg/day) at screening.
- •4.FPG 126 – 270 mg/dl (7.0 – 15.0 mmol/L) at screening and at randomization.
- •5.Male and female patients, age 18 to 85 years of age inclusive.
- •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 80
- •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 (15mmol/L) at Visit 1 and Visit 102.
- •2.Use of any of the following medications as assessed at Visit 1:
- •a.use of any antidiabetic medication within the last 12 weeks, except metformin
- •b.use of weight control products including weight-loss medications in the last 12 weeks.
- •c.use of oral (=7 consecutive days) or chronic parenteral or intra-articular corticosteroid treatment within the last 8 weeks. Inhaled or topical steroids without systemic effects will be allowed.
- •d.treatment with growth hormone within the previous 6 months.
- •e.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 at Visit 1:
- •a.acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state (including precoma and 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.other acute or chronic disease which may cause tissue hypoxic (e.g. respiratory insufficiency, shock) within the past 6 months.
- •e.coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months.
- •f.Stroke, transient ischemic attack, or reversible ischemic neurologic deficit within the past 6 months.
- •g.unstable angina within the past 3 months.
- •h.sustained and clinically relevant ventricular arrhythmia (patients with premature ventricular contractions if deemed not clinically significant may be enrolled).
- •i.active substance abuse, alcohol abuse and history of alcohol-related diseases within the past 2 years.
- •j.type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- •k.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.
- •l.hepatic disorder
- •m.acute infections which may affect blood glucose control within the past 4 weeks.
- •n.Acute conditions with the potential to alter renal function within the past 6 months, such as:
- •dehydration,
- •severe infection,
- •intravascular administration of iodinated contrast agents
- •4.any of the following significant laboratory abnormalities as assessed at Visit 1:
- •a.clinically significant increase or reduction in thyroid stimulating hormone (TSH) outside of the normal range.
- •b.clinically significant renal dysfunction: glomerular filtration rate (GFR) <60mL/min/1.73m2 (via MDRD formula).
- •c.alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Visit 1, confirmed by repeated measurements within 3 working days.
- •d.total bilirubin > 2 x ULN and/or direct bilirubin > 1 x ULN confirmed by repeated measurements within 3 working days.
- •e.positive Hepatitis B surface antigen (HBsAg).
- •f.positive Hepatitis C virus (HCV) antibody test (anti-HCV).
- •g.elevated fasting triglycerides (TGs) > 500mg/dL (5.65mmol/L), confirmed by a repeated measurements within 3 working days.
- •h.clinically significant laboratory abnormalities which, in the opinion of the investigator, cause the patient to be considered inappropriate for inclusion in the study.
- •5.any of the following electrocardiographic abnormalities at Visit 1:
- •a.second or third degree atrio-v
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