Antidiabetic Triple Therapy Effects on Change of Hscrp and Other Markers after Stroke: a Randomized Controlled Trial

Background: Diabetes mellitus is a major risk factor of ischemic stroke. It is unsettled issue for which antidiabetic drugs is the best strategy for stroke patients with diabetes mellitus. Therefore it is important to figure out the most efficient way to prevent cardiovascular event in stroke patients. High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation and its level can independently predict risk of cardiovascular disease and can be used as a surrogate for future cardiovascular event.Objective: To clarify whether triple therapy with combination with metformin, pioglitazone, and an SGLT2 inhibitor (empagliflozin or dapagliflozin or canagliflozin) for 6 months can reduce hsCRP in stroke patients with diabetes mellitus. Methods: This study will be conducted in 7 hospitals in Taiwan, enrolling 140 patients. Inclusion criteria were ischemic stroke within 6 months, having diabetes with Hb1c ＞ 7%, eGFR ＞ 45, no history of heart failure or amputation, and willing to sign informed consent. Patients will be randomly assigned to active treatment and conventional groups. In active arm, physicians will prescribe metformin, pioglitazone, and an SGLT2 inhibitor. In control arm, physicians will prescribe antidiabetic drug based on their personal experience. Treatment duration will be 6 months. The primary endpoint is hsCRP change from baseline in active vs control arm. The secondary endpoints are insulin resistance, BNP, urine albumin creatinine ratio, and HbA1C change from baseline in active vs control arm. We will also compare modified Rankin Scale 0-1 at 6 months between 2 groups.Expectation: IF combination therapy with metformin, pioglitazone, and an SGLT2 inhibitor is able to reduce inflammation and other biomarkers, such approach can be considered as priority therapy for ischemic stroke patients with diabetes.

Project ID:PC10907-0947
External Project ID:MOST109-2314-B182-033