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Proposal 1307

Title of the Proposed Research

The Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in the Treatment of Type 2 Diabetes Mellitus in Patients with Chronic Kidney Disease

Lead Researcher

Dr. Navdeep Tangri

Affiliation

Seven Oaks General Hospital Renal Program

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

27 November 2015

Lay Summary

Diabetes is the leading cause of chronic kidney disease (CKD) worldwide. In patients with CKD and diabetes, high blood glucose leads to many health issues, including rapid progression to kidney failure requiring dialysis. A reduction in kidney function limits the options for diabetic drugs in patients with Type 2 Diabetes. Many drugs typically used to care for diabetes have multiple side-effects and end up doing more harm than good.

Dipeptidyl peptidase-4 (DPP-4) inhibitors represent a new drug that lowers blood glucose. These drugs are associated with a low risk of dangerously low blood glucose levels and weight gain and have minimal side effects. DPP-4 inhibitors are supposedly safe for CKD patients at all stages.

Multiple studies have looked at the use of DPP-4 inhibitors in the treatment of type 2 diabetes. A recent analysis of those studies has shown that DPP4 inhibitors are just as safe and effective as other diabetic drugs. However, previous studies have mostly focused on patients with preserved kidney function, despite the fact that CKD is common in patients with type 2 diabetes. Because of this we are designing a review that will look at the DPP-4 inhibitors in patients with CKD and type-2 diabetes.

The findings from our review will be published in a medical journal and available to all who have access to it. Physicians who treat patients with type 2-diabetes and CKD will be able to use the research findings in their practice and will gain a better understanding for prescribing DPP-4 inhibitors.

Study Data Provided

Study TAKEDA-SYR-322_402: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.