NCT00607087已完成4 期
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
适应症
干预措施
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
- 289
- 试验地点
- 1
- 主要终点
- Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
研究概览
简要总结
Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion.
Main Secondary objectives:
To compare insulin glulisine, insulin aspart and insulin lispro on:
- Unexplained hyperglycemia
- Infusion set occlusion
- Hypoglycemic episodes,7-point blood glucose profiles
- Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis
- Time to change the infusion set
- HbA1c (Glycosylated hemoglobin)
- Overall safety: incidence of adverse events
详细描述
The maximal duration of the study participation for patients was 41 weeks and one day, split in:
- a 2-week screening period,
- a 39-week treatment period: 3 treatment periods of 13 weeks with a crossover alternative regimen, including a dose adjustment period of 1 week at the beginning of each period (sequence1: insulin glulisine, then insulin aspart, then insulin lispro; sequence2: insulin aspart, then insulin lispro, then insulin glulisine; sequence 3: insulin lispro, then insulin glulisine, then insulin aspart)
- and a follow-up period of 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetic subjects
- •Treated with insulin for at least 2 years and by CSII for at least 6 months
- •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
- •Using the same type of infusion set (catheter and cannula) for at least 3 months
- •Performing at least 3 blood glucose controls per day
- •HbA1c < 8.5%
- •Body mass index (BMI) < 35 kg/m²
- •Ability and willingness to perform blood glucose and ketone monitoring using the Sponsor-provided combined glucose and ketone meter and patient diary at home
排除标准
- •Diabetes other than Type 1
- •Total daily dose of insulin greater than 90 U/day
- •Using an insulin pump requiring pre-filled cartridges
- •History of infection at infusion site requiring a drainage in the last 3 months
- •History of severe episodes of ketosis requiring hospitalization in the last 6 months
- •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 ophthalmoscopic examination should have been performed in the 2 years prior to study entry
- •Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method) or breastfeeding
- •Treatment with systemic corticosteroids or medication known to influence insulin sensitivity in the 3 months prior to visit 1
- •Treatment with antidiabetic drug other than insulin in the 3 months prior to visit 1
- •Likelihood of requiring treatments during the study which are not permitted
- •Treatment with an investigational product in the 30 days prior to visit 1
- •History of sensitivity to the study drugs or to drugs with a similar chemical structure
- •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
- •Night shift workers
- •Impaired renal function as shown by serum creatinine ≥1.5 mg/dL (133 μmol/L) or ≥1.4 mg/dL (124 μmol/L) in men and women, respectively
- •Impaired hepatic function as shown by Alanine aminotransferase (ALT) and/or Aspart aminotransferase (AST) greater than three times the upper limit of normal range)
- •Alcohol or drug abuse in the last year
- •Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Sequence 3
Experimental
Sequence 3: insulin lispro / insulin glulisine / insulin aspart
干预措施: Insulin lispro (Drug)
sequence 1
Experimental
sequence 1: insulin glulisine / insulin aspart / insulin lispro.
干预措施: Insulin glulisine (Drug)
sequence 1
Experimental
sequence 1: insulin glulisine / insulin aspart / insulin lispro.
干预措施: Insulin lispro (Drug)
sequence 1
Experimental
sequence 1: insulin glulisine / insulin aspart / insulin lispro.
干预措施: Insulin aspart (Drug)
Sequence 2
Experimental
Sequence 2: insulin aspart / insulin lispro / insulin glulisine
干预措施: Insulin glulisine (Drug)
Sequence 2
Experimental
Sequence 2: insulin aspart / insulin lispro / insulin glulisine
干预措施: Insulin lispro (Drug)
Sequence 2
Experimental
Sequence 2: insulin aspart / insulin lispro / insulin glulisine
干预措施: Insulin aspart (Drug)
Sequence 3
Experimental
Sequence 3: insulin lispro / insulin glulisine / insulin aspart
干预措施: Insulin glulisine (Drug)
Sequence 3
Experimental
Sequence 3: insulin lispro / insulin glulisine / insulin aspart
干预措施: Insulin aspart (Drug)
结局指标
主要结局
Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion
时间窗: over 13 weeks of each treatment period
Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason. Pump infusion set occlusion defined by at least one of the following items: * pump occlusion alarm, * patient observation of an occlusion, spontaneously or because of elevated blood glucose value.
次要结局
- Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion(over 13 weeks of each treatment period)
- Percentage of Patients With at Least One Unexplained Hyperglycemia(over 13 weeks of each treatment period)
- Monthly Rate of Unexplained Hyperglycemia(over 13 weeks of each treatment period)
- Percentage of Patients With at Least One Confirmed Infusion Set Occlusion(over 13 weeks of each treatment period)
- Monthly Rate of Confirmed Infusion Set Occlusion(over 13 weeks of each treatment period)
- Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis(over 13 weeks of each treatment period)
- Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis(over 13 weeks of each treatment period)
- Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year(over 13 weeks of each treatment period)
- Rate of Severe Symptomatic Hypoglycemia Per Patient-year(over 13 weeks of each treatment period)
- Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year(over 13 weeks of each treatment period)
- Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site(over 13 weeks of each treatment period)
- Time Interval Between Infusion Set Changes: All Changes(over 13 weeks of each treatment period)
- Time Interval Between Infusion Set Changes in Routine(over 13 weeks of each treatment period)
- Glycosylated Hemoglobin: HbA1c(over 13 weeks of each treatment period)
- Total Daily Basal Insulin Infusion(over 13 weeks of each treatment period)
- Total Daily Bolus Insulin Dose(over 13 weeks of each treatment period)
研究者
研究点 (1)
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