A 24-week, Multicenter, Randomized, Open-Label, Parallel-group StudyComparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 929
- 试验地点
- 158
- 主要终点
- Change From Baseline in HbA1c to Week 24
研究概览
简要总结
Primary Objective:
To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24.
Secondary Objectives:
Change From Baseline in HbA1c to Week 12
To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on:
- Change in Fasting plasma glucose (FPG);
- Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile;
- Percentage of participants reaching HbA1c targets <7% or ≤6.5%;
- Percentage of participants reaching HbA1c targets <7% or ≤6.5% without severe and/or confirmed hypoglycemia
- Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia.
To assess the safety in each treatment group.
To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO).
Percentage of participants requiring rescue therapy.
详细描述
The maximum study duration per participant was approximately 27 weeks: an up to 2-week screening period, a 24-week randomized treatment period (including 12 weeks active titration), and a 7-day posttreatment safety 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 —（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 up to Week 24 on top of non-insulin antidiabetic treatment.
干预措施: Insulin glargine, 300U/mL (Drug)
Toujeo
Toujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
干预措施: Non-insulin anti-diabetic treatment (Drug)
Tresiba
Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment .
干预措施: Insulin degludec, 100 U/mL (Drug)
Tresiba
Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment .
干预措施: Non-insulin anti-diabetic treatment (Drug)
结局指标
主要结局
Change From Baseline in HbA1c to Week 24
时间窗: Baseline, Week 24
Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted Least Square (LS) means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 24-week on-treatment period.
次要结局
- Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24(Week 12, and Week 24)
- Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event(Week 12, and Week 24)
- Change From Baseline in HbA1c to Week 12(Baseline, Week 12)
- Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period(Day 1-Week 12, Week 13-Week 24, and 24 Week Period)
- Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period(Baseline to Week 24)
- Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period(Day 1-Week 12, Week 13-Week 24, and 24 Week Period)
- Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24(Baseline, Week 12 and Week 24)
- Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point(Baseline, Week 12 and Week 24)
- Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point(Baseline, Week 12 and Week 24)
- Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period(Baseline to Week 24)
- Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period(Day 1-Week 12, Week 13-Week 24, and 24 Week Period)
- Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period(Day 1-Week 12, Week 13-Week 24, and 24 Week Period)