An Open Label Randomized Multicenter Study to Assess Patient Preference for and Evaluate Clinical Benefit of Insulin Glargine (Lantus®) SoloSTAR® Pen Versus Conventional Vial/Syringe Method of Insulin Glargine (Lantus®) Injection Therapy in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Patient Overall Preference
研究概览
简要总结
Primary Objective:
To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM)
Secondary Objectives:
To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following parameters:
Randomization/Crossover phase:
- Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus vial and syringe
Re-randomization phase:
- Change in Fasting Plasma Glucose (FPG) from week 4 to week 10
- Percentage of patients achieving FPG<110 mg/dL at week 10
- Change in Lantus dose injected per day (U) from week 4 to week 10
Observational phase:
- Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (<7%) at week 40
- Time to first observation of HbA1c<7% during the observational phase
- Percentage of patients who discontinue Investigational Product (IP) during the observational phase due to dissatisfaction with their current device
All phases:
- Percentage of patients who discontinue IP during each phase of the study
- Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)
详细描述
This study consisted of a 1 week Screening Phase, a 4-week Randomization/Crossover Phase, a 6-week Re-randomization Phase, followed by a 30 week Observational Phase.
The total duration of study participation was up to 41 weeks with a total treatment duration of up to 40 weeks of Lantus exposure.
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 85 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 (insulin glargine) vial & syringe
10 mL vial, 1000 U per vial for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight.
干预措施: Insulin Glargine (Drug)
Lantus (insulin glargine) SoloSTAR pen
3 mL SoloSTAR pre-filled disposable insulin delivery device (pen), 300 U per device for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Patient Overall Preference
时间窗: At week 4 (end of crossover phase)
The patient preference was assessed in terms of the difference in scores obtained from the overall preference question 14d "Overall, what is your level of preference for each of the insulin delivery systems?" 5 points scale: from 1=Not preferred to 5= Always preferred
次要结局
- Patient Preference Composite Score(At week 4 (end of crossover phase))
- Healthcare Professional's (HCP) Recommendation(At week 4 (end of crossover phase))
- Change in Fasting Plasma Glucose (FPG)(From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase))
- Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL(At week 10 (end of re-randomization phase))
- Change in Lantus Dose Injected Per Day(From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase))
- Percentage of Patients Achieving HbA1c Goal(measured at week 40 or at study discontinuation)
- Time to First Observation of HbA1c <7%(From week 10 to week 40 (observational phase))
- Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase(From baseline to week 4 (crossover phase))
- Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase(From week 4 to week 10 (re-randomization phase))
- Percentage of Patients Who Discontinued Investigational Product During the Observational Phase(From week 10 to week 40 (observational phase))