A multinational, prospective, non-interventional 24-week study to assess effectiveness and safety of initial combination therapy with vildagliptin/metformin in drug-naÃ¯ve type 2 diabetes mellitus patients in a real life setting - INITIA

ovartis Healthcare Private Limited0 个研究点目标入组 765 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Provide written informed consent before any data is collected
•2. >18 years of age
•3.Diagnosed with T2DM prior to study entry
•4.At least one documented HbA1c >=7.5% measured within 4 weeks prior to study entry
•5.Prescribed treatment with
•vildagliptin/metformin initial dual therapy within 4 weeks of study entry and in compliance with the local prescribing information, i.e. vildagliptin/metformin dual therapy twice daily as either single pill combination or separate pill form
•6.Are T2DM drug-naÃ¯ve, defined as either patients who 1) have never received an antidiabetic medication, or 2) have not taken any antidiabetic medication in the last three months before study entry AND never for longer than three consecutive months, with the exception of the medication of interest described above

•1.Contraindications to vildagliptin or metformin as per the local approved prescribing information
•2.Use of any investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer

发起方

ovartis Healthcare Private Limited