52-week, Open, Randomized, Multinational, Multicenter Clinical Trial Comparing Insulin Glulisine in Combination With Insulin Glargine in an Intensified Insulin Regimen to a Two-injection Conventional Insulin Regimen in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control Pretreated With a Two-injection Conventional Insulin Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 311
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
Primary objective:
The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.
Secondary objectives:
Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic events, adverse events, change of late diabetes complications, weight, body-mass-index, course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria, standard lab and quality of life/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
- 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
1
Mealtime insulin glulisine 3x daily and insulin glargine 1 x daily subcutaneously
干预措施: Insulin Glulisine (Drug)
1
Mealtime insulin glulisine 3x daily and insulin glargine 1 x daily subcutaneously
干预措施: Insulin Glargine (Drug)
2
Two daily injection conventional insulin therapy
干预措施: Insulin Therapy (Drug)
结局指标
主要结局
HbA1c
时间窗: From baseline to study endpoint
Self monitored BG (SMBG) values
时间窗: During the whole treatment phase
Body weight/body mass index (BMI)
时间窗: From baseline to study endpoint and all other visits
Fasting blood lipid profile
时间窗: From baseline to study endpoint and all other visits
Urine albumin
时间窗: From baseline to study endpoint and all other visits
Total daily insulin dose
时间窗: From baseline to study endpoint
次要结局
- Vital signs(From baseline to study endpoint and all other visits)
- Adverse events(Throughout the study,)
- Standard laboratory tests(From baseline to study endpoint and all other visits)
- Physical examination(From baseline to study endpoint and all other visits)