National (Brazil), Phase IV, Multicentric, Open Label, Parallel, Comparative Study of the Use of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 72
- 试验地点
- 10
- 主要终点
- Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%.
研究概览
简要总结
Primary Objective:
>To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group.
Secondary Objectives:
- Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment.
- Incidence of confirmed symptomatic and nocturnal hypoglycemia.
- Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment.
- Creatinine clearance at baseline and after each period of treatment.
- Overall safety: Incidence of adverse events.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
group 1: insulin glargine + insulin glulisine
insulin glargine once daily + glulisine at meal times
干预措施: INSULIN GLARGINE (Drug)
group 1: insulin glargine + insulin glulisine
insulin glargine once daily + glulisine at meal times
干预措施: INSULIN GLULISINE (Drug)
group 2 NPH insulin + regular insulin
NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times
干预措施: NPH insulin (insulin isophane) (Drug)
group 2 NPH insulin + regular insulin
NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times
干预措施: Regular insulin (Drug)
结局指标
主要结局
Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%.
时间窗: From visit 1 (Day 1) to visit 13 (Day 169)
次要结局
- Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL).(From baseline and Visit 13 (Day 169))
- Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.(From baseline and Visit 13 (Day 169))
- Weight variation(From baseline to the end of treatment at visit 13 (day 169))
- Creatinine clearance variation(From baseline to the end of treatment at visit 13 (day 169))
- Incidence of confirmed severe hypoglycemia: plasma glucose level < 36 mg/dL (2 mmol/L) or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration(From baseline and Visit 13 (Day 169))