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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2023

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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.
    • 28 Apr 2015 Accrual to date is 120% according to United Kingdom Clinical Research Network.
    • 01 Dec 2011 Results reporting patient satisfaction with insulin treatment published in Diabetes, Obesity and Metabolism.

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