EUCTR2010-022658-18-FI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 in type 2 diabetes mellitus patients = 70 years (drug-naive or inadequately controlled on oral agents).
适应症
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
- 280
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
- •age: = 70 years inclusive at Visit 1.
- •female or male.
- •patients with a confirmed diagnosis of T2DM: i/treated with a stable dose of OADs for at least 12 weeks prior to Visit 1. OADs that are allowed in this study are metformin, sulfonylurea (SU), thiazolidinediones (TZDs), a-glucosidase inhibitors or meglitinides, used either as monotherapy or in combination. ii/drug-naive patients diagnosed at least 12 weeks prior to Visit 1 (drug-naive is defined as no treatment with OADs for at least 12 weeks prior to Visit 1 and no treatment with OADs for > 3 consecutive months at any time in the past).
- •HbA1c of = 7% and =10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled.
- •body mass index (BMI) in the range of 19-45 kg/m2 inclusive at Visit 1.
- •agreement to maintain a stable background medication dose throughout the study, if currently receiving OADs.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 =270mg/dL (15mmol/L) at Visit 1.
- •use of any of the following medications as assessed at Visit 1:
- •- prior use of insulin treatment (for = 7 consecutive days) in the preceding 12 weeks.
- •- use of DPP-4 inhibitors or GLP-1 analogues in the preceding 12 weeks.
- •- use of weight control products including weight-loss medications in the last 12 weeks.
- •- use of oral (=7 consecutive days) or chronic parenteral or intra-articular corticosteroid treatment within the last 8 weeks.
- •- treatment with growth hormone within the previous 6 months.
- •- 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.
- •a history or evidence of any of the following:
- •- acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state (including coma) within the past 6 months.
- •- current diagnosis of congestive heart failure (NYHA III or IV).
- •- myocardial infarction within the past 6 months.
- •- coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months.
- •- Stroke, transient ischemic attack, or reversible ischemic neurologic deficit within the past 6 months.
- •- unstable angina within the past 3 months.
- •- sustained and clinically relevant ventricular arrhythmia (patients with premature ventricular contractions if deemed not clinically significant may be enrolled).
- •- type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing’s syndrome or acromegaly-associated diabetes).
- •- 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.
- •- 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.
- •- acute infections which may affect blood glucose control within the past 4 weeks.
- •any of the following significant laboratory abnormalities as assessed at Visit 1
- •- clinically significant elevation or reduction of thyroid stimulating hormone (TSH) outside of the normal range.
- •- clinically significant renal dysfunction: glomerular filtration rate (GFR) <30mL/min/1.73m2 (via modification of diet in renal disease (MDRD) formula).
- •- alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Visit 1, confirmed by repeat measure within 3 working days.
- •- total bilirubin > 2 x ULN and/or direct bilirubin > 1 x ULN confirmed by repeat measure within 3 working days.
- •- positive Hepatitis B surface antigen (HBsAg).
- •- positive Hepatitis C virus (HCV) antibody test (anti-HCV).
- •- elevated fasting triglycerides (TGs) > 500mg/dL (5.65mmol/L).
- •any of the following electrocardiographic abnormalities at Visit 1
- •- second or third degree atrio-ventricular block without a pacemaker.
- •- long QT syndrome or QTc > 500ms.
- •history of hypersensitivity to DPP-4 inhibitors.
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