Use of metformin add on to insulin among patients diagnosed Type 1 diabetes mellitus in UK

Study type
Protocol
Date of Approval
Study reference ID
17_253
Lay Summary

Among the 3.8 million of patients aged over 16 suffering diabetes in England, approximately 10% have Type 1 Diabetes Mellitus (T1DM), which is caused by damage to cells in the pancreas meaning the body is unable to produce sufficient insulin. The lack of insulin results in high blood glucose levels which can lead to major health issues relating to eyes, kidneys and heart. T1DM is incurable and is treated through continuous insulin treatment with the aim to maintain blood glucose levels. The National Institute for Care and health Excellence (NICE) provides guidance to healthcare professionals (e. g. General Practitioner) on how to manage T1DM. To improve blood glucose control in T1DM, NICE suggests overweight or obese T1DM patients may be considered for adding metformin (an oral diabetes medicine that helps control blood glucose levels in Type 2 Diabetes Mellitus) to insulin therapy. However, metformin is not licensed in the UK for the treatment of T1DM and we did not find any evidence on its use in T1DM in the UK. We therefore would like to know for potential future research, how frequently metformin is used in recent clinical practice in the UK.

Technical Summary

Approximately 10% of patients suffering diabetes in England have Type 1 diabetes (TD1M), which is caused by damage to cells in the pancreas meaning the body is unable to produce sufficient insulin. This insulin lack results in high blood glucose levels which can lead to major health issues. T1DM is treated through continuous insulin therapy to maintain blood glucose levels. To improve blood glucose control in T1DM, National Institute for Care and health Excellence (NICE) suggests overweight or obese T1DM patients may be considered for adding metformin to insulin therapy. However, metformin is not licenced in UK for T1DM management and the results of a recent clinical trial did not support this NICE recommendation. We therefore would like to know how frequently metformin is used in recent clinical practice in the UK. Participants will be patients aged 18 and older with T1DM diagnosis and no Type 2 diabetes diagnosis registered anytime and at least one insulin prescription between January 1, 2015 and June 30, 2017 after a minimum of 12 months of prior insulin use.

Health Outcomes to be Measured

Metformin use in Type 1 diabetes mellitus (only count).

Collaborators

Celine Quelen - Chief Investigator - Creativ-Ceutical ( do not use )
Celine Quelen - Corresponding Applicant - Creativ-Ceutical ( do not use )
Una Rigney - Collaborator - AstraZeneca Ltd - UK Headquarters