NCT00540709已完成4 期
PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro
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
- 58
- 主要终点
- Primary efficacy data was HbA1c.
研究概览
简要总结
Whether a once-daily basal injection of insulin glargine with mealtime injections of insulin lispro achieves equivalent glycaemic control (HbA1c) to administration of insulin lispro by continuous subcutaneous insulin infusion in Type 1 diabetic patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of type 1 diabetes mellitus for at least one year.
- •Subjects with no previous experience with Continuous Subcutaneous Insulin Infusion (CSII) or insulin glargine,
- •capable of managing a basal-bolus regimen and meeting glycaemic targets in accordance with the protocol.
- •HbA1c > than or = to 6.5 < than or = to 9.0% at screening visit with evidence of lack of insulin secretion (e.g. fasting C-peptide concentration is < 0.1 nmol/l with fasting blood glucose(FBG) > 126 mg/dl).
排除标准
- •Previous therapy using insulin glargine or continuous subcutaneous insulin infusion.
- •Lipodystrophy preventing adequate use of CSII.
- •Unwilling or unlikely to be able to use MiniMedr insulin pump with insulin lispro for CSII.
- •Unwilling or unlikely to be able to use an MDI regimen with insulin glargine and insulin lispro in accordance with the protocol (for instance, subjects who routinely use a twice-daily mixed insulin regimen should not be included).
- •History of more than two severe hypoglycaemic episodes in the past 6 months.
- •Acute infection which, in the opinion of the investigator, could lead to increased insulin resistance.
- •Acute or chronic metabolic acidosis.
- •Episode of DKA (diabetic ketoacidosis) within the last three months.
- •Active, uncontrolled, advanced diabetic retinopathy.
- •Impaired hepatic function, as shown by > 2.5 times the upper limit of normal range for AST.
- •Impaired renal function, as shown by serum creatinine > 1.5mg/dl.
- •History of gastroparesis. Congestive heart failure requiring ongoing pharmacological treatment.
- •Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
- •Treatment with a non-selective beta blocker.
- •Treatment with inhaled or systemic steroids.
- •History of hypersensitivity to insulin lispro or to any drug with a similar chemical structure to insulin glargine or insulin lispro or to any of the excipients of the insulin glargine and insulin lispro preparations used in the study.
- •Any malignancy within the last five years, except adequately treated basal cell carcinoma.
- •History within the last two years or current addiction to substances of abuse including ethanol.
- •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
Primary efficacy data was HbA1c.
时间窗: At week 24 (the last day of the treatment period).
次要结局
- Secondary efficacy data included HbA1c.(At Week 8 and Week 16 after starting study medication and selfmonitored blood glucose (SMBG) measurements.)
研究者
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