NCT00783744已完成3 期
28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/70 Bid in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Antidiabetic Drug Treatment.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 375
- 试验地点
- 3
- 主要终点
- Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %
研究概览
简要总结
To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus patients type 2, poorly controlled with oral antidiabetic drug treatment(glimepiride 3 or 4 mg od or any sulfonylurea similar to glimepiride 3 or 4 mg in combination with metformin in a dose at least similar to 850 mg once daily)
- •HbA1c value ≥ 7.5 % to ≤ 10.5 %
- •FBG ≥ 120 mg/dl (6.6 mmol/l)
- •BMI ≤ 35 kg/m²
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Insulin Glargine + Glimepiride + Metformin
干预措施: Insulin Glargine (Drug)
1
Experimental
Insulin Glargine + Glimepiride + Metformin
干预措施: Glimepiride (Drug)
1
Experimental
Insulin Glargine + Glimepiride + Metformin
干预措施: Metformin (Drug)
2
Active Comparator
Insulin monotherapy with premixed insulin NPH 30/70
干预措施: Insulin monotherapy with premixed insulin NPH 30/70 (Drug)
结局指标
主要结局
Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %
时间窗: At endpoint
次要结局
- Change of fasting blood glucose(baseline to endpoint)
- Change of fasting plasma glucose(baseline to endpoint and all visits)
- Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)(Baseline to endpoint)
- Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)(Baseline to endpoint)
- Frequency of subjects with FBG ≤ 100 mg/dl (5.5 mmol/l), 100 mg/dl < FBG ≤ 120 mg/dl (5.5 mmol/l < FBG ≤ 6.6 mmol/l), 120 mg/dl < FBG ≤ 150 mg/dl (6.6 mmol/l < FBG ≤ 8.3 mmol/l) and > 150 mg/dl (> 8.3 mmol/l)(At endpoint)
- Change of nocturnal & mean daytime blood glucose(baseline to endpoint)
研究者
研究点 (3)
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