EUCTR2007-003579-38-AT进行中（未招募）不适用
Effect of insulin glulisine compared to insulin aspart and insulin lispro when administered by Continuous Subcutaneous Insulin Infusion (CSII) on specific pump parameters in patient with Type 1 Diabetes Mellitus - Pump Study
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
- 270
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
- •1.Men or women, aged from 18 to 75 years inclusive
- •2.Type 1 diabetic subjects
- •3.Treated with insulin for at least 2 years and by CSII for at least 6 months
- •4.Using the same insulin (insulin glulisine, insulin aspart or insulin lispro) in CSII for at least 3 months with the same external pump compatible with the 3 short acting insulin analogues used in the study
- •5.Using the same type of infusion set (catheter and cannula) for at least 3 months
- •6.Performing at least 3 blood glucose controls per day
- •7.HbA1c < 8.5%
- •8.Body mass index (BMI) < 35 kg/m2
- •9.Ability and willingness to perform blood glucose and ketone monitoring using the Sponsor-provided combined glucose and ketone meter and patient diary at home
- •10. Written informed consent obtained prior to enrolment in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •1.Diabetes other than Type 1
- •2.Total daily dose of insulin greater than 90 U/day
- •3.Using an insulin pump requiring pre-filled cartridges
- •4.History of infection at infusion site requiring a drainage in the last 3 months
- •5.History of severe episodes of ketosis requiring hospitalization
- •6.Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study. An ophtalmoscopic examination should have been performed in the 2 years prior to study entry
- •7.Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method) or breastfeeding
- •8.Treatment with systemic corticosteroids or medication known to influence insulin sensitivity in the 3 months prior to visit 1
- •9.Treatment with antidiabetic drug other than insulin in the 3 months prior to visit 1
- •10.Likelihood of requiring treatments during the study which are not permitted
- •11.Treatment with an investigational product in the 30 days prior to visit 1
- •12.History of sensitivity to the study drugs or to drugs with a similar chemical structure
- •13.Presence of any condition (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actual or anticipated that the Investigator feels would compromise the patient safety or limit his/her successful participation in the study
- •14.Night shift workers
- •15.Impaired renal function as shown by serum creatinine = 1.5 mg/dL (133 µmol/L) or = 1.4 mg/dL (124 mmol/L) in men and women, respectively
- •16.Impaired hepatic function as shown by Alanine aminotransferase (ALT) and/or Aspart aminotransferase (AST) greater than three times the upper limit of normal range)
- •17.Alcohol or drug abuse in the last year
- •18.Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •19.Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikehood of completing the study
- •20.Patient is the Investigator or any sub-Investigator, research assistant, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
研究者
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