Association between HbA1c and all-cause mortality in people with type 2 diabetes treated with glucose-lowering therapies with a higher and lower risk of inducing hypoglycaemia: a retrospective cohort study.

Date of Approval
Application Number
16_007
Technical Summary

A U-shaped association between glycated haemoglobin (HbA1c) and all-cause mortality has been demonstrated previously. An increased risk of hypoglycaemia could explain the increased risk of all-cause mortality associated with low HbA1c values. We will use a retrospective cohort study design. The objective of this study is to explore the association between HbA1c and all-cause mortality in patients with type 2 diabetes treated with glucose-lowering therapies associated with a higher risk of causing hypoglycaemia (insulin, meglitinides and sulfonylureas as monotherapy or in combination with other glucose-lowering therapies) and those treated with glucose-lowering therapies associated with a lower risk of causing hypoglycaemia (acarbose, metformin, DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 agonists and thiazolidinediones as monotherapy or in combination with other glucose-lowering therapies excluding insulin, sulfonylureas or meglitinides).
Regimens initiated between 1 January 2004 and 31 December 2014 will be selected. HbA1c will be modelled as 12 monthly updated time-dependent mean and cumulative mean values. Cox proportional hazards models will be used to explore the association between HbA1c and all-cause mortality within each regimen of interest.

Collaborators

Craig Currie - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Sarah Holden - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences

Linkages

HES Admitted Patient Care;ONS Death Registration Data