Determinants associated with treatment modification in the first year of treatment in patients with type 2 diabetes mellitus in the United Kingdom, before and after implementation of the new guideline: a retrospective cohort study

Date of ISAC Approval: 
01/06/2018
Lay Summary: 
Most patients with type 2 diabetes receive metformin, a commonly used medicine for type 2 diabetes. When use of metformin does not result in enough improvement or is not tolerated, another medicine is added to metformin or patients switch to another medicine (a second-line medicine). In the last years several new second-line medicines for the treatment of type 2 diabetes have become available. As result, general practitioners (GPs) have the option to choose the best second-line medicine for an individual patient. This is also recommended by the new type 2 diabetes guideline for doctors in the UK, the NICE (National Institute for Health and Care Excellence) guideline. NICE is an organisation, part of the Department of Health in the UK, that publishes guidelines for health care professionals and patients to help them make decisions about treatment and health care. However, it is not known if implementation of the new guideline resulted in more individual prescribing of second-line medicines and which (patient related) factors influence the prescribing of GPs. Therefore, the aim of this study is to identify factors associated with prescribing of different second-line medicines in patients with type 2 diabetes before and after implementation of the new NICE guideline.
Technical Summary: 
This study's primary objective is to identify determinants associated with prescribing of different second-line therapies in patients with T2DM before and after implementation of the new NICE (National Institute for Health and Care Excellence) guideline. All new users of metformin only and aged 18+ will be followed until they receive a prescription for a glucose-lowering agent other than metformin. We will investigate patient and treatment related determinants, geographic variations and socio-economic related factors. Our secondary objectives are: 1) to investigate if the prescription of a second-line oral glucose lowering agent was an addition or switch of therapy; 2) time to treatment change. Mean time to change in treatment will be estimated per drug class by using Kaplan-Meier survival analysis, with change in treatment as the outcome event. Determinants of treatment change will be estimated by Cox proportional hazards regression. Results will be presented separately for patients with a treatment modification before and after the introduction of the new NICE guideline (December 2015).
Health Outcomes to be Measured: 
Second-line antidiabetic prescribing before and after implementation of the new NICE guideline Adherence to guidelines
Collaborators: 

Frank De Vries - Chief Investigator - Utrecht University
Andrea Burden - Collaborator - Utrecht University
Andre Krings - Collaborator - Atrium MC
Coen Stehouwer - Collaborator - Maastricht University
Frank De Vries - Corresponding Applicant - Utrecht University
Johanna Annemariek Driessen - Collaborator - Utrecht University
Judith van Dalem - Collaborator - Utrecht University
Martijn Brouwers - Collaborator - Maastricht University
Dr Olaf Klungel - Collaborator - Utrecht University

Linkages: 
Primary Care Vision