A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes Inadequately Controlled on Therapy With Oral Agents, and Assessing the Requirement for More Complex Insulin Regimens to Achieve and Maintain Glycaemic Control, Their Efficacy and Durability

Trial Profile

A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes Inadequately Controlled on Therapy With Oral Agents, and Assessing the Requirement for More Complex Insulin Regimens to Achieve and Maintain Glycaemic Control, Their Efficacy and Durability

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Sep 2017

At a glance

  • Drugs Insulin detemir (Primary) ; Insulin aspart; Insulin aspart/insulin protamine aspart
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms 4-T
  • Sponsors Novo Nordisk
  • Most Recent Events

    • 15 Sep 2017 Results assessing efficacy and tolerability of insulin detemir, insulin aspart [NovoRapid; Novo Nordisk] and biphasic insulin aspart 30 [BIasp, NovoMix 30, NovoLog Mix 70/30; Novo Nordisk], when added to current OAD (oral anti-diabetic drug) treatment in patients with type 2 diabetes mellitus, were presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
    • 10 Jun 2017 Biomarkers information updated
    • 28 Apr 2015 Accrual to date is 120% according to United Kingdom Clinical Research Network.
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