Efficacy and Safety of Intensive Insulin Therapy With Insulin Glulisine in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Change in HbA1c level for patients with addition of glulisine at week 12
研究概览
简要总结
Primary Objective:
To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10).
Secondary Objectives:
- Percentage of patients with HbA1c < 7% at week 24.
- Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event at week 24.
- Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24.
- Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24.
- Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24.
- Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.
详细描述
The study is divided in 3 periods:
- a 2-week run-in period,
- a 12-week treatment period 1
- a 12-week treatment period 2 study treatment duration per patient: 24 weeks study duration per patient: 26 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（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
Intensive insulin regimen
Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: + insulin glulisine if HbA1c ≥7% at week 12 (end of treatment period 1)
干预措施: INSULIN GLARGINE (Drug)
Intensive insulin regimen
Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: + insulin glulisine if HbA1c ≥7% at week 12 (end of treatment period 1)
干预措施: INSULIN GLULISINE (Drug)
insulin regimen
Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: no change, if HbA1c <7% at week 12 (end of treatment period 1)
干预措施: INSULIN GLARGINE (Drug)
结局指标
主要结局
Change in HbA1c level for patients with addition of glulisine at week 12
时间窗: between week 12 and week 24 (end of treatment period)
次要结局
- Percentage of patients with HbA1c level < 7%(at week 24 (end of treatment period))
- Percentage of patients with HbA1c level < 7% and no symptomatic nocturnal hypoglycemia event(at week 24 (end of treatment period))
- Fasting Plasma Glucose(at week 0, week 12 and week 24)
- 7-point Self Monitoring of Blood Glucose(at week 0, week 12 and week 24)
- Daily dose of insulin glargine(at week 24 (end of treatment period))
- Daily dose of insulin glulisine(at week 24 (end of treatment period))
- Systolic / diastolic blood pressure, heart rate, weight change(from week 0 (baseline) to week 24 (end of treatment period))
- Hypoglycemia (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe)(from week 0 (from baseline) to week 24 (end of treatment))