Comparison of a Basal Plus One Insulin Regimen (Insulin Glargine/Insulin Glulisine) With a Biphasic Insulin Regimen (Insulin Aspart/Insulin Aspart Protamine 30/70) in Type 2 Diabetes Patients Following Basal Insulin Optimisation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 463
- 试验地点
- 74
- 主要终点
- Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
The primary objective is to demonstrate the non-inferiority at six months of a basal plus one insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes.
The secondary objective are:
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To compare the proportion of patients in each treatment group reaching HbA1c target (< 7%) at the end of the treatment period
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To compare the rates of hypoglycaemia (total, severe, nocturnal)
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To compare the change in body weight from visit 10 to visit 24
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To compare the change in diabetes specific quality of life and other patient reported outcomes from visit 10 to visit 24
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Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c)
-
Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire
-
Insulin Treatment Satisfaction Questionnaire (ITSQ)
-
EuroQoL 5 Dimensions (EQ5D) questionnaire
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To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24
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
Lantus + Apidra basal plus one
Before randomization (common with arm 2):
A 1 to 2 weeks of screening period: patients will continue on their current insulin and oral antidiabetic drug (OAD) therapy.
8 weeks of run-in period: patients will switch their treatment for insulin glargine (one daily injection at bedtime) and all OADs (with the exception of metformin) will be discontinued.
After randomization:
24 weeks of treatment period: Insulin (Lantus®) + metformin (if applicable) + a single injection of insulin glulisine (Apidra®), the latter administered at the patients largest meal of the day
干预措施: INSULIN GLARGINE (HOE901) (Drug)
Lantus + Apidra basal plus one
Before randomization (common with arm 2):
A 1 to 2 weeks of screening period: patients will continue on their current insulin and oral antidiabetic drug (OAD) therapy.
8 weeks of run-in period: patients will switch their treatment for insulin glargine (one daily injection at bedtime) and all OADs (with the exception of metformin) will be discontinued.
After randomization:
24 weeks of treatment period: Insulin (Lantus®) + metformin (if applicable) + a single injection of insulin glulisine (Apidra®), the latter administered at the patients largest meal of the day
干预措施: Insulin Glulisine (Drug)
NovoMix 30 Biphasic
Before randomization (common with arm 1):
A 1 to 2 weeks of screening period: patients will continue on their current insulin and oral antidiabetic drug (OAD) therapy.
8 weeks of run-in period: patients will switch their treatment for insulin glargine (one daily injection at bedtime) and all OADs (with the exception of metformin) will be discontinued.
After randomization:
24 weeks of treatment period: Insulin aspart/ insulin protamine crystallised insulin aspart (NovoMix® 30) + metformin (if applicable)
干预措施: Insulin aspart (Drug)
结局指标
主要结局
Glycosylated Haemoglobin (HbA1c)
时间窗: At week 7 and week 32
次要结局
- Hypoglycaemia (total, severe and nocturnal)(At week 0 and week 32)
- Diabetes specific quality of life measured using ADDQoL (Audit of Diabetes-Dependent Quality of Life questionnaire) and other patient reported outcomes measured using EQ5D (EuroQoL 5 Dimensions questionnaire)(Week 8 and week 32)
- Weight(At week 8 and week 32)