Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure. (DINAMO)
2013年11月7日 更新者：Sanofi
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.
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.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
72
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Curitiba、巴西、80060-900
- Investigational Site Number 076-007
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Fortaleza、巴西、60015-052
- Investigational Site Number 076-010
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Fortaleza、巴西、60115-282
- Investigational Site Number 076-001
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Porto Alegre、巴西、91350-250
- Investigational Site Number 076-003
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São Paulo、巴西、01244-030
- Investigational Site Number 076-005
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São Paulo、巴西、01308-050
- Investigational Site Number 076-013
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São Paulo、巴西、01323-001
- Investigational Site Number 076-004
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São Paulo、巴西、04024-002
- Investigational Site Number 076-002
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São Paulo、巴西、o4039-000
- Investigational Site Number 076-009
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Taguatinga、巴西、72155000
- Investigational Site Number 076-006
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Type 2 diabetes and renal failure in use of NPH regular insulin or fast-acting analog and HbA1c >= 8%.
- Albuminuria or microalbuminuria diabetic retinopathy.
- Creatinine clearance < 60 mL/min/1,73 m2 and >30 mL/min/1,73 m2
Exclusion criteria:
- Hypersensibility to insulin glargine or any other component of the insulin formulation.
- Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months.
- History of diabetic ketoacidosis or positive GAD antibodies.
- Advanced retinopathy needing laser therapy.
- Diagnosed advanced neuropathy
- Severe hepatic disease or active hepatitis.
- Cardiac failure class III or IV (NYHA).
- Patients on hemodialysis.
- Diagnosed cancer.
- Active infection.
- Current therapy with steroids.
- Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：group 1: insulin glargine + insulin glulisine
insulin glargine once daily + glulisine at meal times
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Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
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有源比较器：group 2 NPH insulin + regular insulin
NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times
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Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%.
大体时间：From visit 1 (Day 1) to visit 13 (Day 169)
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From visit 1 (Day 1) to visit 13 (Day 169)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL).
大体时间：From baseline and Visit 13 (Day 169)
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From baseline and Visit 13 (Day 169)
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Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.
大体时间：From baseline and Visit 13 (Day 169)
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From baseline and Visit 13 (Day 169)
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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
大体时间：From baseline and Visit 13 (Day 169)
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From baseline and Visit 13 (Day 169)
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Weight variation
大体时间：From baseline to the end of treatment at visit 13 (day 169)
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From baseline to the end of treatment at visit 13 (day 169)
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Creatinine clearance variation
大体时间：From baseline to the end of treatment at visit 13 (day 169)
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From baseline to the end of treatment at visit 13 (day 169)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年7月1日
初级完成 (实际的)
2013年10月1日
研究完成 (实际的)
2013年10月1日
研究注册日期
首次提交
2010年5月11日
首先提交符合 QC 标准的
2010年5月12日
首次发布 (估计)
2010年5月13日
研究记录更新
最后更新发布 (估计)
2013年11月8日
上次提交的符合 QC 标准的更新
2013年11月7日
最后验证
2013年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.