NCT00526513已完成4 期
Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
Primary Objectives:
To determine the effect of insulin glulisine on glycemic control (HbA1c, FBG & PPBG) from baseline to the end of the study.
Secondary Objectives:
To evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the incidence of hypoglycemia and other adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 or type 2 diabetes mellitus previously treated for 6 months with prandial insulin + Basal insulin or Premix (Type I) or by either a basal insulin + OAD or basal + RHI/other short acting analogue insulin or Premix (Type II) with HbA1c >7%.
- •Adequate hepatic and renal functions
- •Ability and willingness of a tight antidiabetic therapy and to perform blood glucose self-monitoring and especially blood glucose profiles, using a blood glucometer at home.
排除标准
- •Pregnant or lactating women or women of childbearing potential not using adequate contraception.
- •Patients with hypersensitivity to insulin glulisine or to any of the excipients.
- •History of diabetic ketoacidosis.
- •Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which may require surgical treatment within 3 months of study entry.
- •Alcohol abuse or drug abuse.
- •Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or psychiatric illness, other serious illnesses, uncontrolled medical conditions or active infections making implementation of the protocol difficult.
- •Medical, psychiatric, or neurologic condition that renders the patient unable to understand the nature and scope of the study. Mental retardation or language barrier such that the patient is unable to give informed consent.
- •Participation in an investigational trial within 30 days of study entry.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Glycosylated Haemoglobin (HbA1c)
时间窗: At 6 months after the treatment start
次要结局
- Control of Fasting Blood Glucose (FBG)(At 3 months after the treatment start)
- Control of Post-Prandial Glycemia (PPBG)(At 6 months after the treatment start)
研究者
研究点 (1)
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