跳至主要内容
临床试验/NCT03703869
NCT03703869已完成不适用

A 12-month Prospective Observational Study Assessing the Real-world Clinical Effectiveness, Safety and Health-economic Benefits of Toujeo® Initiation After Oral Antidiabetic Drug Failure in Insulin-naïve Patients With Type 2 Diabetes Mellitus

Sanofi388 个研究点 分布在 3 个国家目标入组 4,589 人开始时间: 2018年3月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Sanofi
入组人数
4,589
试验地点
388
主要终点
Change in HbA1c at month 6

研究概览

简要总结

Primary Objective:

Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).

Secondary Objectives:

  • Assess effectiveness in achieving glycemic goal measured by HbA1c;
  • Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;
  • Assess requirement for intensification of therapy by additional antidiabetics.
  • Assess incidence of hypoglycemia;
  • Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);
  • Assess change in body weight.

详细描述

Patients will be observed for one year

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Insulin glargine (U300)

Insulin glargine (U300) dosage and dosing time as per local product labeling

干预措施: Insulin glargine (U300) (Drug)

结局指标

主要结局

Change in HbA1c at month 6

时间窗: Baseline, month 6

Percentage of patients achieving Hemoglobin A1c \<7.0%.

次要结局

  • Change in HbA1c(Baseline, months 3, 6, 12)
  • Change in Self-Monitored Plasma Glucose(Baseline, months 3, 6, 12)
  • Hypoglycemia(Baseline to month 12)
  • Adverse events(Baseline to month 12)
  • Serious adverse events(Baseline to month 12)
  • Change in fasting plasma glucose(Baseline, months 3, 6, 12)
  • Body weight(Baseline to month 12)

研究者

发起方
Sanofi
申办方类型
Industry
责任方
Sponsor

研究点 (388)

Loading locations...

相似试验