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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Vildagliptin/metformin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms INITIAL
  • Sponsors Novartis Healthcare
  • Most Recent Events

    • 15 Sep 2017 Primary endpoint (To assess the effectiveness of vildagliptin/metformin dual therapy (change in HbA1c from baseline to week 24) as initial combination in drug-naive adult type 2 diabetes patients) has been met, according to results presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
    • 15 Sep 2017 Status changed from active, no longer recruiting to completed, according to results presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
    • 15 Sep 2017 Results assessing effectiveness and safety of initial combination therapy with vildagliptin/metformin in drug-naive Type II diabetes patients, were presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
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