Better Acceptance of a Single Injection Apidra (Insulin Glulisine) Added to Once Daily Lantus (Insulin Glargine) Versus Twice Daily Premixed Insulin in a Real Life Use Setting
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Glycosylated Haemoglobin (HbA1c) Value
研究概览
简要总结
Primary Objective:
To demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily premixed insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to endpoint.
Secondary Objective:
- To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status, DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction Questionnaire)
- To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose) and proportion of patients with a HbA1c <7%
- To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight gain and injection site reactions)
- To determine the total insulin dose, average insulin glargine, insulin glulisine and premixed insulin dosages.
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 —（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
- 未提供
研究组 & 干预措施
Insulin glargine + Insulin glulisine
Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal
干预措施: Insulin glulisine (Drug)
Insulin glargine + Insulin glulisine
Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal
干预措施: Insulin glargine (Drug)
Premixed insulin
twice daily premixed insulin (before breakfast and evening meal).
干预措施: Premixed insulin (Insulin Aspart 30/70 ) (Drug)
结局指标
主要结局
Glycosylated Haemoglobin (HbA1c) Value
时间窗: at screening (week - 2), week 12 (if available) and 24
Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients.
Self Measured Blood Glucose (SMBG)
时间窗: at Baseline (week 0), week 2, 12 and 24
次要结局
- DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)(at week 0, 12 and 24)
- DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)(at week 24)
- ITSQ (Insulin Treatment Satisfaction Questionnaire)(at week 0, 12 and 24)
- Hypoglycemic events(at week 0, 2, 12 and 24)
- Adverse Events (excluding hypoglycemic events)(at week - 2, 0, 2, 12 and 24)