Insights into the management of type 2 diabetes

• Research type

  Research Study

• Full title

  Insights into the management of type 2 diabetes

• IRAS ID

  189373

• Contact name

  Simon de Lusignan

• Contact email

  s.lusignan@surrey.ac.uk

• Sponsor organisation

  Eli Lilly and Company Ltd.

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Background:
  There is a large range of options for the second and third line management of Type 2 Diabetes Mellitus (T2DM). This includes a range of injectable as well as oral medications.
  
  Whilst clinical trials have demonstrated the efficacy in clinical practice, they do not report effectiveness in clinical practice. Real world evidence is needed to understand comparative effectiveness, and how medications are used in practice.

  Objective:
  To compare adherence and persistence with second and third line medicine used to treat T2DM, and to report the glycaemic thresholds and other factors associated with a change in therapy.

  Method:
  We will use data held in the RCGP Research and Surveillance Centre database. We will identify people with T2DM (n ~ 30,000) and a comparator group who do not have T2DM (~ 350,000) but have similar cardiovascular risk.

  We will describe adherence and persistence with the different classes of second and third line agents used to treat T2DM. We will look at the numbers of dispensed prescriptions, as well as those that are prescribed.

  We will also report the adherence and persistence with statins and angiotensin modulating anti-hypertensive medications, between the people with T2DM and the comparator population. We will explore if the same explanatory variables explain any patterns of adherence in people with and without T2DM.

  The final part of the investigation is to explore the glycaemic threshold and other factors associated with the introduction of second or third line therapy in T2DM. The focus of this investigation will be on the introduction of injectable therapy.

  Anticipated outcomes:
  The study should inform patterns of adherence and persistence with different types of second and third line therapy in diabetes; and the threshold at which injectable therapy is introduced.

• REC name

  London - South East Research Ethics Committee

• REC reference

  15/LO/1755

• Date of REC Opinion

  1 Oct 2015

• REC opinion

  Favourable Opinion