Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-naive Type 2 Diabetes Patients Uncontrolled on Oral Hypoglycemic Agent Treatment Initiating Basal Insulin Therapy With Either Insulin Glargine or NPH Insulin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Health Assessment, Patient treatment satisfaction and Quality-of-Life
研究概览
简要总结
Primary Objective:
To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL).
Secondary Objective:
A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of:
- Glycaemic parameters: 7 blood glucose profiles
- Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia
- Change in lipid status
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
Insulin glargine: Lantus® (100 U/ml) in TactiPen® re-usable pen
干预措施: Insulin Glargine (HOE901)/NPH Insulin (Drug)
2
Neutral Protamine Hagedorn basal insulin: Insuman® Basal (100 I.U./ml) in TactiPen® re-usable pen
干预措施: Insulin Glargine (HOE901)/NPH Insulin (Drug)
结局指标
主要结局
Health Assessment, Patient treatment satisfaction and Quality-of-Life
时间窗: At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint)
次要结局
- Glycaemic parameters assessment(At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint))
- Anteropometric data (Weight, waist circumference) assessment(At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint))
- Lipid assessment(At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint))
- Hypoglycemia assessment(Throughout the study from starting until the week 48)