A 26-Week, Multi-Center, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-Term Intensive Insulin Therapy: Basal Insulin Based Treatment (With Prandial OADs Combination) Versus Twice-daily Premixed Insulin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Change in hemoglobin A1c (HbA1c)
研究概览
简要总结
Primary Objective:
To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved.
Secondary Objectives:
- To assess efficacy in terms of percentage of patients achieving HbA1c <7% and HbA1c <7% without hypoglycemia.
- To assess efficacy in terms of percentage of patients achieving fasting plasma glucose (FPG) <7 mmol/L and FPG <7 mmol/L without hypoglycemia.
- To assess safety in term of occurrence of moderate/severe hypoglycemia.
- To assess daily blood glucose (BG) variation.
- To assess patient satisfaction.
详细描述
The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study
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
- 18 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
Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
干预措施: INSULIN GLARGINE (HOE901) (Drug)
Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
干预措施: Insulin Glulisine (Drug)
Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
干预措施: Repaglinide (Drug)
Glargine based therapy
Once daily glargine plus prandial oral anti-hyperglycemic drugs
干预措施: Acarbose (Drug)
Premixed insulin
Twice daily premixed insulin
干预措施: Biphasic insulin aspart 30 (Drug)
Premixed insulin
Twice daily premixed insulin
干预措施: Metformin (Drug)
结局指标
主要结局
Change in hemoglobin A1c (HbA1c)
时间窗: Baseline to Week 24
Change in HbA1c from baseline to week 24
次要结局
- Patients with fasting plasma glucose (FPG) <6.1 mmol/L(At Week 12 and Week 24)
- Hypoglycemic events(Baseline to Week 24)
- European quality of life - 5 dimensions (EQ-5D)(Baseline to Week 24)
- Patients with FPG <6.1 mmol/L without hypoglycemia(At Week 12 and Week 24)
- Patients with HbA1c <7% without hypoglycemia(At Week 12 and Week 24)
- Change in body weight(Baseline to Week 24)
- Patients with FPG <7 mmol/L(At Week 12 and Week 24)
- Insulin dose(At Week 24)
- Subgroup analysis(At week 24)
- Patients with FPG <7 mmol/L without hypoglycemia(At Week 12 and Week 24)
- Patients with HbA1c <7%(At Week 12 and Week 24)
- Change in FPG(Baseline to Week 24)
- Daily BG variation at week 24(At Week 24)