A 12-week Randomized, Controlled Trial to Compare TOUJEO® and TRESIBA® in Terms of Glucose Values in Target Range and Variability During Continuous Glucose Monitoring in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 343
- 试验地点
- 7
- 主要终点
- Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis
研究概览
简要总结
Primary Objective:
To demonstrate the non-inferiority of insulin glargine 300 units per milliliter (U/ml) in comparison to insulin degludec 100 U/ml on glycemic control and variability in participants with diabetes mellitus.
Secondary Objective:
To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Glucose Monitoring.
To evaluate the safety of insulin glargine 300 U/ml in comparison to insulin degludec 100 U/ml.
详细描述
The duration of the study per participant was around 18 weeks: 1 or 2 weeks of screening followed by a 4-week run-in period, a 12-week treatment period and a 2 to 4 days follow-up period.
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
Toujeo
Toujeo (Insulin Glargine, 300 U/ml) subcutaneous (SC) injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.
干预措施: Insulin glargine, 300 U/ml (Drug)
Tresiba
Tresiba (Insulin Degludec, 100U/ml) SC injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog.
干预措施: Insulin degludec, 100U/ml (Drug)
结局指标
主要结局
Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis
时间窗: During Week 10 up to Week 12
The Continuous Glucose Monitoring (CGM) system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained using analysis of covariance (ANCOVA) model on data obtained from the multiple imputations during Week 10 to Week 12.
次要结局
- Glucose Total Coefficient of Variation (CV%)(During Week 10 up to Week 12)
- Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis(During Week 10 up to Week 12)
- Glucose Within-day CV% and Between-day CV%(During Week 10 up to Week 12)
- Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12(Baseline, Week 12)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12(Baseline, Week 12)
- Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night)(During Week 10 up to Week 12)
- Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night)(During Week 10 up to Week 12)
- Percentage of Time With Glucose Level >180 Milligrams Per Deciliter(During Week 10 up to Week 12)
- Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter(During Week 10 up to Week 12)
- Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period(From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days))
- Number of Hypoglycemic Events Per Participant Year During the On-treatment Period(From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days))