Phase IV, Multicenter, International, Non-comparative, Open Label Study of Efficacy and Safety of Basal Bolus Therapy (Insulin Glargine + Insulin Glulisine) in Patients With T1 Diabetes Previously Uncontrolled on Any Insulin Regimen.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 206
- 试验地点
- 43
- 主要终点
- Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))
研究概览
简要总结
Primary Objective:
To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day, tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type 1 Diabetes Mellitus (T1DM).
Secondary Objectives:
To evaluate:
- The change of hemoglobin A1c (HbA1c) from baseline to week 12
- The percentage of patients with HbA1c < 7% at week 12 and week 24
- The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and week 24
- The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week 24
- The incidence of symptomatic hypoglycemias
- Adverse events
详细描述
After a two-week run-in period patients will enter a six-month treatment period.
Estimated study duration per patient : 26 weeks (including a 2-week run-in period).
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 60 Years（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
Insulin glargine dosage will be individually titrated once a week to obtain FPG 80-120 mg/dL (4.5-6.7 mmol/L).
Insulin glulisine dosage will be individually titrated once a week to obtain a 2-hour postprandial plasma glucose (PPG) < 180 mg/dL (<10.0 mmol/L) and ideally around 140 mg/dL.
干预措施: INSULIN GLARGINE (Drug)
Insulin glargine + insulin glulisine
Insulin glargine dosage will be individually titrated once a week to obtain FPG 80-120 mg/dL (4.5-6.7 mmol/L).
Insulin glulisine dosage will be individually titrated once a week to obtain a 2-hour postprandial plasma glucose (PPG) < 180 mg/dL (<10.0 mmol/L) and ideally around 140 mg/dL.
干预措施: INSULIN GLULISINE (Drug)
结局指标
主要结局
Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))
时间窗: between baseline (week 0) and endpoint (week 24)
次要结局
- Change of HbA1c(from baseline to week 12)
- Percentage of patients with HbA1c < 7%(at week 12 and week 24)
- Fasting Blood Glucose (FBG)(at baseline, week 12 and week 24)
- 7-point Self Monitoring of Blood Glucose (SMBG)(at baseline, week 12 and week 24 (to be performed the week preceding each visit on two consecutive days))
- Daily dose for insulin glulisine(At baseline, week 12 and week 24)
- Daily dose for insulin glargine(At baseline, week 12 and week 24)
- Symptomatic hypoglycemias(From baseline (week 0) to endpoint (week 24))