Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 708
- 试验地点
- 87
- 主要终点
- HbA1c
研究概览
简要总结
Primary Objective:
To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.
Secondary Objective:
To compare between treatment groups:
- Plasma glucose (fasting, nocturnal) over time,
- Changes from baseline in HbA1c over time,
- Percentage of patients who reach the target of HbA1c <7 and <6.5,
- Use of prandial insulin as rescue medication at month 6,
- Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
- Daily dose of insulin,
- Change in body weight from baseline,
- Evolution of 8-point plasma-glucose (PG) profiles,
- Overall safety,
- Patient reported outcomes (treatment satisfaction).
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
- 30 Years 至 70 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
1
Before randomization (common with arm 2):
2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride
After randomization:
36 weeks of study treatment phase: Insulin Glargine + OAD(s) at stable dose
干预措施: Insulin Glargine (HOE901) [Lantus] (Drug)
1
Before randomization (common with arm 2):
2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride
After randomization:
36 weeks of study treatment phase: Insulin Glargine + OAD(s) at stable dose
干预措施: Glimepiride (Drug)
2
Before randomization (common with arm 1):
2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride
After randomization:
36 weeks of study treatment phase: NPH + OAD(s) at stable dose
干预措施: Glimepiride (Drug)
2
Before randomization (common with arm 1):
2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride
After randomization:
36 weeks of study treatment phase: NPH + OAD(s) at stable dose
干预措施: human insulin [NPH] (Drug)
结局指标
主要结局
HbA1c
时间窗: Recorded at baseline (week 0), week 12, week 24 and week 36
次要结局
- Need of additional prandial insulin(At week 24)
- Self-monitored fasting plasma glucose (FPG)(Before baseline (week 0), weeks 12, 24 and 36)
- 8-points profiles(The week before baseline, at 12, 24 and 36 weeks)
- Episodes of hypoglycemia(From the week -2 to the week 36)
- Daily doses of insulin(At week 1, week 2, week 3, week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 20, week 24, week 28, week 32, week 36)