A 24-week, Open, Multicenter, Comparative Study of 2 Strategies (Including Insulin Glargine Versus Premixed Insulin) for the Therapeutic Management of Patients With Type 2 Diabetes Failing Oral Agents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 934
- 试验地点
- 96
- 主要终点
- Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L]
研究概览
简要总结
Primary Objective:
To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents.
Secondary Objectives:
To assess the effect of insulin glargine in comparison with premixed insulin on :
- Evolution of HbA1c level during the treatment period Percentage of patients who reach the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L)
- Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L) >Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L) >Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles
- Evolution of weight
- Hypoglycemia occurrence
- Dose of insulins
- Evolution of liver function
- Overall safety
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
- 35 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
Administered once a day in the evening, at the same time every day. The starting daily dose is 0.2 U/Kg of body weight or 12 U, at the investigator's decision.
Insulin glulisine is administered for patients of the insulin glargine group requiring insulin glulisine at week 12 (visit 11).
Insulin glulisine is administered prior (10-15 min) to the main meal of the day, which is the meal with highest Post-Prandial Plasma Glucose (PPPG) on the 3 profiles performed before week 12.
Starting dose is of 4 units per day.
干预措施: INSULIN GLARGINE (Drug)
Insulin glargine
Administered once a day in the evening, at the same time every day. The starting daily dose is 0.2 U/Kg of body weight or 12 U, at the investigator's decision.
Insulin glulisine is administered for patients of the insulin glargine group requiring insulin glulisine at week 12 (visit 11).
Insulin glulisine is administered prior (10-15 min) to the main meal of the day, which is the meal with highest Post-Prandial Plasma Glucose (PPPG) on the 3 profiles performed before week 12.
Starting dose is of 4 units per day.
干预措施: INSULIN GLULISINE (Drug)
Premixed insulin
administered once a day (in the evening at dinner) or twice a day (in the morning before breakfast and in the evening at dinner). Starting daily dose will be 6 U at breakfast and 6 U at dinner, if administered twice a day or 12 U at dinner if administered once a day
干预措施: PREMIXED INSULIN (Drug)
结局指标
主要结局
Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L]
时间窗: From baseline (visit 2, week 0) to visit 14 (week 24)
次要结局
- Self-monitored PG (Plasma Glucose) values over 3 consecutive days(before visit 12 (week 16))
- 7-point plasma glucose (PG) profile recorded on 3 consecutive days(From baseline (visit 2, week 0) to visit 14 (week 24))
- Insulin doses of the day before each visit(from visit 3 (week 1) to visit 14 (week 24))
- Weight and supine blood pressure(From baseline (visit 2, week 0) to visit 14 (week 24))
- Biochemistry and lipid profile(From baseline (visit 2, week 0) to visit 14 (week 24))