A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 24
- 主要终点
- Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM
研究概览
简要总结
Diabetes is a major concern for dialysis units, as it is now the most common cause of end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than one patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type 2 diabetes) and especially in East part of France.
Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly from cardiovascular disease. Tight glycaemic and blood pressure control in diabetic patients has an important impact in reducing risk of progression nephropathy. Data are scarce on how diabetes should best be treated in dialysis patients. The evidence for improving glycaemic control in patients on dialysis having an impact on mortality or morbidity is sparse. Indeed, many factors make improving glycaemic control in patients on dialysis very challenging, including therapeutic difficulties with hypoglycaemic agents, monitoring difficulties, dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia.
Standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are contraindicated in patients on dialysis. Thus insulin has been the mainstay of treatment. Newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues have become available, but until recently, renal failure has precluded their use. Newer gliptins, however, are now licensed for use in 'severe renal failure', although they have yet to be trialed in dialysis patients.
The investigators study, using continuous glucose monitoring as a new tool for monitoring of therapy should provide information on vildagliptin in add on therapy to insulin in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated by haemodialysis for more than 3 months with 1g/L glucose in dialysate fluid
- •Patients treated by stable doses of insulin (any regimen) for Type 2 diabetes without any oral antidiabetic agent
- •Age > 18 years
- •TGO, TPO and lipase < 3x ULN
- •effective means of contraception
- •Non-inclusion Criteria:
- •Blood transfusion in the 2 previous months
- •Life expectancy less than 1 year
- •Chronic inflammatory disease
- •Steroid treatment > 5mg/day
- •Cancer (evolutive or requiring chemotherapy or radiotherapy) with the exception of breast intraductal carcinoma operated
- •Patient waiting for programmed surgery
- •History of cardiovascular disease (stroke, coronary heart disease, hospitalization for heart failure) in the 4 previous months
- •Patients suffering from stage 3 and 4 cardiac insufficiency
- •Non-compliant patients
- •History of pancreatitis
- •History of angioedema
- •Hypersensitivity to the active substance or to any of the excipients of Galvus®
- •Pregnancy or breastfeeding
排除标准
- 未提供
研究组 & 干预措施
Insulin alone
Use the usual frequency and dose
干预措施: Insulin (Drug)
Insulin and Vildagliptin
vildagliptin 50 mg/day during 3 months
结局指标
主要结局
Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM
时间窗: up to day 3
次要结局
- CGM parameters at baseline and month 3(Other CGM parameters at baseline and month 3)
- Number of hypoglycaemic events(Hypoglycaemic events at baseline, month 3)
- Mean HbA1C and Glycated albumin(HbA1C and Glycated albuminat baseline and month 3)