Further insights into the management of type 2 diabetes
Research type
Research Study
Full title
Further insights into the management of type 2 diabetes
IRAS ID
212480
Contact name
Simon de Lusignan
Contact email
Sponsor organisation
Eli Lilly and Company Ltd.
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
Background:
There are many options for the second and third line management of Type 2 diabetes (T2DM). This includes injectable as well as oral medications. It is important that medications are prescribed based on clinical need and that there are no disparities in prescribing based on socio-economic status or to vulnerable patient groups.
Whilst clinical trials have demonstrated the efficacy of hypoglycaemic agents for glucose lowering and in a limited number of cases, for cardiovascular benefit, the effectiveness of these drugs in day-to-day clinical practice may be very different. Real world evidence is needed to understand comparative effectiveness, and how medications are used in practice.
Objectives:
To describe:
1) Disparities in the prescribing and outcomes of people with T2DM;
2) Whether glycated haemoglobin (HbA1c) twelve months after diagnosis of T2DM, is independently associated with lowering the proportion of new macrovascular events after 10 years.Method:
We will use data held in the Royal College of General Practitioners Research and Surveillance Centre database for this study; utilising our existing cohort (N >55,000) of adult patients with T2DM to compare prescribing rates of different classes of agents used to treat T2DM. We will also explore other healthcare indicators across different age, gender, ethnic, socioeconomic groups, and localities.
For the second part of this investigation we will stratify people according to the presence of retinopathy at T2DM diagnosis (as a surrogate for duration of hyperglycaemia prior to diagnosis of diabetes), and compare major adverse cardiac events, all-cause mortality, as well as other important outcomes between these groups, to establish the impact of early intensification in people with T2DM.
Anticipated outcomes:
The study will inform whether healthcare disparities exist in the prescribing trends for T2DM patients from different groups; and whether early intensive treatment following diagnosis will help prevent macrovascular events and improve survival.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
16/WM/0425
Date of REC Opinion
30 Sep 2016
REC opinion
Favourable Opinion