A Twenty-six Week, Randomized, Open-label, 2-Arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to "Standard of Care" Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-Month Extension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 705
- 试验地点
- 128
- 主要终点
- Change in HbA1c (percentage %)
研究概览
简要总结
Primary Objective:
To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change
Secondary Objectives:
- To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as HbA1c change.
- To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
- Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on Hypoglycemia).
- Change in fasting plasma glucose (FPG).
- Change in body weight.
- Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc).
- Change in hypoglycemic control subscale (HCS)
- Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.
详细描述
The total study duration will be up to 55 weeks, consisting of a 1-week screening period at the site, a 26-week treatment period, and a 26-week extension 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 will be administered once daily in addition to noninsulin antidiabetic agents
干预措施: insulin glargine (U300) (Drug)
"Standard of care" commercially available basal insulin
Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents
干预措施: insulin glargine (U100) (Drug)
"Standard of care" commercially available basal insulin
Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents
干预措施: NPH insulin (Drug)
"Standard of care" commercially available basal insulin
Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents
干预措施: insulin detemir (Drug)
"Standard of care" commercially available basal insulin
Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir or Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to noninsulin antidiabetic agents
干预措施: insulin degludec (Drug)
结局指标
主要结局
Change in HbA1c (percentage %)
时间窗: Baseline to 6 Months
次要结局
- Percentage of patients whose HbA1c decreased at least 1%(At Month 6 and maintained at Month 12)
- Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%)(At Month 6 and Month 12)
- Change in fasting plasma glucose(Baseline to Month 6 and Month 12)
- Percentage of patients requiring intensification(At Month 6 and Month 12)
- Time to intensification(At Month 6 and Month 12)
- Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (BG <54 mg/dL [3.0 mmol/L]) symptomatic or severe hypoglycemia(At Month 6 and Month 12)
- Change in HbA1c (percentage %)(Baseline to Month 12)
- Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)(At Month 6 and Month 12)
- Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not(At Month 6 and Month 12)
- Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (blood glucose (BG) ≤70 mg/dL [3.9 mmol/L]) symptomatic or severe hypoglycemia(At Month 6 and Month 12)