Antidiabetic Triple Therapy Effects on Surrogate Tests After Stroke
Status:
Recruiting
Trial end date:
2023-01-31
Target enrollment:
Participant gender:
Summary
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 8 hospitals in Taiwan, enrolling 200 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, albuminuria
change from baseline in active vs control arm.
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.
Phase:
Phase 2
Details
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborators:
Chiayi Christian Hospital National Taiwan University Hospital