NCT00964574已完成4 期
Multicentre, Open, Non-randomised Controlled Phase IV Clinical Trial of Efficacy and Safety for Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine
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
- 68
- 试验地点
- 1
- 主要终点
- Mean change in Glycosylated haemoglobin (HbA1c)
研究概览
简要总结
Primary Objective:
To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients
Secondary Objective:
To evaluate the insulin glulisine doses To assess the patient satisfaction
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
- •6.5 <=HbA1c <= 11% at visit 1
- •BMI <35 kg/m²
- •Provision of signed and dated informed consent prior to any study procedures
- •Ability and willingness to complete study diaries and questionnaires
- •Demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
- •A negative pregnancy test for all females of childbearing potential.
- •Exclusion criteria:
- •Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients
- •Pregnant women
- •Active proliferative diabetic retinopathy
- •Impaired hepatic or renal function
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
研究组 & 干预措施
APIDRA + LANTUS basal
Experimental
The 2 first weeks, patients will receive subcutaneous injection of Insulin Glulisine and Insulin Glargine once daily in hospital. The rest of the treatement is to be take at home until week 12
干预措施: INSULIN GLULISINE (HMR1964) (Drug)
APIDRA + LANTUS basal
Experimental
The 2 first weeks, patients will receive subcutaneous injection of Insulin Glulisine and Insulin Glargine once daily in hospital. The rest of the treatement is to be take at home until week 12
干预措施: INSULIN GLARGINE (Drug)
结局指标
主要结局
Mean change in Glycosylated haemoglobin (HbA1c)
时间窗: Week 12
次要结局
- Mean Glycosylated haemoglobin (HbA1c)(Week 12)
- Mean Fasting Blood Glucose and mean Post Prandial Glycemia(Week 12)
- Number of documented symptomatic hypoglycaemic episodes(From week 0 to week 12)
- Mean dose and mean dose change of insulin glulisine, basal glulisine and total insulin from baseline(week 12)
- Mean change of Fasting Blood Glucose and Post Prandial Glycemia(From week 0 to week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Insulin Glulisine, Diabetes Mellitus Type 1Diabetes Mellitus, Type 1NCT00397553Sanofi104
已完成
3 期
OPAL - Insulin Glulisine, Diabetes MellitusDiabetes Mellitus Type 2NCT00272012Sanofi396
进行中（未招募）
1 期
Efficacy and safety of insulin glulisine compared with insulin lispro in children and adolescents with type 1 diabetes mellitus: a 26-week, multicenter, open, parallel clinical trial - HMR1964D/3001Type 1 diabetes mellitusEUCTR2004-000616-70-FIAventis Pharmaceuticals, Inc.560
进行中（未招募）
1 期
Efficacy and safety of insulin glulisine compared with insulin lispro in children and adolescents with type 1 diabetes mellitus: a 26-week, multicenter, open, parallel clinical trial - HMR1964D/3001Type 1 diabetes mellitusEUCTR2004-000616-70-GBAventis Pharmaceuticals, Inc.560
进行中（未招募）
不适用
Efficacy and safety of insulin glulisine compared with insulin lispro in children and adolescents with type 1 diabetes mellitus: a 26-week, multicenter, open, parallel clinical trial - HMR1964D/3001Type 1 diabetes mellitusEUCTR2004-000616-70-DEAventis Pharmaceuticals, Inc.560