Demographic and clinical characteristics of T2DM patients treated with DPP-4 and SGLT2 inhibitors in the absence of a current clinical guideline - A CPRD Study

Date of ISAC Approval: 
28/08/2015
Lay Summary: 
A number of glucose-lowering treatments have been licensed to treat patients with type 2 diabetes mellitus (T2DM) since the last update of the National Institute for Health and Care Excellence (NICE) clinical guideline for the management of T2DM (CG66/87) in 2009. Glucose-lowering treatments which were not licensed at the time of the guideline publication included three dipeptidyl peptidase-4 (DPP-4) and three sodium/glucose cotransporter 2 (SGLT2) inhibitors. These drugs have been widely prescribed despite not yet being included in the treatment pathway in the guideline. The primary objective is to understand how DPP-4 and SGLT2 inhibitors have been prescribed to patients with T2DM in the absence of an up-to-date clinical guideline. Kidney impairment is one of the most common complications amongst patients with T2DM. Treating these patients can be challenging as many glucose-lowering therapies are not recommended for them. DPP-4 inhibitors are licensed to treat patients with kidney impairment however each DPP-4 inhibitor comes with its specific criterion for dose reduction. The complexity of the dosage could potentially increase the risk of patients being treated with an inappropriate dose. The second objective is to describe the drugs and doses of DPP-4 inhibitors prescribed to T2DM patients with kidney impairment.
Technical Summary: 
The primary objective of this study is to understand the usage of newer agents for the treatment of T2DM, namely DPP-4 and SGLT2 inhibitors by describing demographic and clinical characteristics of patients who have been prescribed the medications. Subsequently, medications and doses of DPP-4 inhibitors prescribed to patients with kidney impairment will be analysed. The method of research will be a descriptive cohort. Patients who have had a prescription for DPP-4 or SGLT2 and were 40 years or older when T2DM was diagnosed will form two study cohorts (i.e., DPP-4 population and SGLT2 population). Descriptive statistics will be used to summarise demographic and clinical characteristics of patients who have been treated with either class of glucose-lowering medications. As a subset of the DPP-4 cohort, patients with moderate to severe kidney impairment will form a second part of the study. The medications and doses/dosage of DPP-4 inhibitors prescribed to this patient population will be described.
Health Outcomes to be Measured: 
The outcomes of the first objective are the demographic and clinical characteristics of patients who had a prescription for a DPP-4 or SGLT2 inhibitor. A subset of the first cohort will form the second part of the study. Of all patients who have had a prescription for a DPP-4 inhibitor, those who had records of kidney impairment will form the cohort for the second objective. The outcomes of the second objective will be the drug and dosage they are prescribed as there are different cut-offs for kidney functions.
Collaborators: 

Dr Sally Lee - Chief Investigator - Celgene Ltd
Anna Scowcroft - Collaborator - Pfizer Ltd - UK
Antonio Ruffolo - Collaborator - Boehringer-Ingelheim International GmbH
John Bolodeoku - Collaborator - Eli Lilly & Co Ltd - US Headquarters
Paula Bingham-Gardiner - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Prashanth Kandaswamy - Collaborator - Boehringer-Ingelheim International GmbH
Dr Sally Lee - Corresponding Applicant - Celgene Ltd
Syed Wasi Hassan - Collaborator - Eli Lilly & Co Ltd - US Headquarters
William Henry Fitzgerald Spencer - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc