Population characteristics and treatment patterns by renal function status in type II diabetes: A population-based cohort study

Study type
Protocol
Date of Approval
Study reference ID
18_113
Lay Summary

Individuals with type 2 diabetes (T2DM) are at higher risk for chronic kidney disease (CKD) than those without T2DM. CKD occurs when there is a loss of kidney function and can be diagnosed by tests which identify high levels of protein in the urine (proteinuria) and/or decreased kidney filtration.1-4 These screening tests are recommended to be performed at least annually and more frequently if abnormal results are observed. There are currently no approved treatments that can reverse the kidney damage. Drugs used to treat high blood pressure have been used to help reduce proteinuria, improve filtration, and delay disease progression. However, they do not address the underlying inflammation which may occur. There are newer drugs being developed to treat the inflammation. The purpose of this study is to assess the overall occurrence and rates of new T2DM diagnoses in the UK and to describe the current standard of care in terms of the screening and treatment of the underlying renal function status. The results from this study will help support public health and policy decisions by identifying groups of individuals who may benefit from improved screening and/or treatments.

Technical Summary

The purpose of this study is to assess the incidence and prevalence of type 2 diabetes (T2DM) in the UK and to describe the current standard of care in terms of screening and treatment, specifically treatment via the renin-angiotensin-aldosterone system (RAAS) route (ACE-Inhibitors [ACE-Is], angiotensin receptor blockers [ARBs] and other therapies that impact the system). Treatment patterns will be assessed in terms of time to treatment, adherence and persistence. Furthermore, the albuminin creatinine ratio (ACR) and/or estimated glomular filtration rate (eGFR) laboratory results will be used to identify the CKD stage so the results can be further stratified into subgroups based on clinical guidelines. Clinical trials are evaluating a new generation of steroidal mineralocorticoid receptor antagonists (sMRAs) which could be a new means to address the inflammation which can underlie the disease mechanism. The results of this study can be used to identify groups of individuals that could benefit from treatment by this proposed new strategy of treating CKD.

Health Outcomes to be Measured

eGFR/ACR Screening (Renal Function)
• Medication Treatment Patterns (RAAS Therapies)

Collaborators

Anthony Louder - Chief Investigator - Aetion, Inc
Anthony Louder - Corresponding Applicant - Aetion, Inc
Alain GAY - Collaborator - Bayer AG
Dana Teltsch - Collaborator - Aetion, Inc
David Vizcaya - Collaborator - Bayer AG
Julie Broughton - Collaborator - Bayer AG
Michael Blankenburg - Collaborator - Bayer AG