NCT00271284已完成3 期
A Crossover, Multicentre, Randomised Trial Comparing the Effect on the Control of Blood Glucose Concentration of Insulin Glargine and Insulin Detemir, Combined With Insulin Glulisine, Used as a Bolus, in Type 1 Diabetic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Efficacy data : fasting blood glucose concentration
研究概览
简要总结
·Main objective: To compare the variability of fasting capillary blood glucose concentration, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics. It is a non-inferiority study.
·Secondary objectives:
Efficacy:
- To compare the variability of blood glucose concentration before the evening meal, observed with insulin glargine combined with insulin glulisine and with insulin detemir combined with insulin glulisine, in type 1 diabetics.
- To record the intra- and inter-daily variability using the MAGE and MODD indices [1,2,3,4]
- To compare the glycaemic profiles (7 points)
- To evaluate the HbA1c concentration, at the end of each period of treatment, weight change, the dose of insulin used and the number of daily injections.
Tolerance:
- To record undesirable events
- To evaluate the safety in use from the record of episodes of hypoglycaemia (symptomatic, diurnal, nocturnal, severe).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Recent history of severe hypoglycaemia (at least 2 events in the 6 months prior to inclusion)
- •An episode of acidocetosis in the 3 months prior to inclusion
- •Proliferating retinopathy, defined as having required treatment by surgery or photocoagulation, in the 6 months prior to visit 1, or non-stabilised (rapidly developing) retinopathy which may require photocoagulation or surgery
- •Pancreatectomy
- •Altered hepatic function (AST or ALT >= 2.5 x normal, in the initial measurements)
- •Altered renal function (plasma creatinine > 1.5 mg/dl)
- •Acute infection
- •Acute or chronic metabolic acidosis
- •Gastroparesis
- •History of cancer in the last 5 years
- •Medically significant cardiovascular, hepatic, neurological or endocrine disease or any other significant disease making carrying out the protocol or interpreting the trial results difficult
- •History of drug or alcohol abuse
- •Subject likely to receive treatment during the trial which is not authorised in the protocol (see Section 6.2), in particular, treatment by corticosteroids whatever the route of administration or dose.
- •Antidiabetic treatment by products other than those supplied within the framework of this study
- •Treatment by another product undergoing development during the 3 months prior to inclusion in the trial
- •Hypersensitivity to one of the study products (insulin glargine, insulin detemir, insulin glulisine) or to one of the excipients present in the insulin preparations, used in the study
- •Working at night
- •Pregnancy
- •Breast-feeding
- •Mental state making the subject incapable of understanding the objectives and possible consequences of the trial
- •Subject unable to submit to the restrictions of the protocol (e.g. uncooperative, incapable of attending monitoring visits and probably incapable of finishing the trial)
- •Subject deprived of his liberty because of an administrative or legal decision
- •The investigator or any member of the team or close to the investigator directly implicated in the trial particularly assistant doctors, pharmacists, nurses, trial coordinator, etc.
- •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
I
Experimental
干预措施: insulin glulisine / insulin glargine (Drug)
II
Active Comparator
干预措施: insulin glulisin / insulin detemir (Drug)
结局指标
主要结局
Efficacy data : fasting blood glucose concentration
时间窗: read daily during the last 2 months of each period
次要结局
- Tolerance data : undesirable events including episodes of hypoglycaemia(throughout the study)
研究者
研究点 (1)
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