Pioglitazone and SGLT2 Inhibitors vs. DPP4 Inhibitors in Patients With Stroke
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- STATUS
- Recruiting
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- End date
- Jan 31, 2024
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- participants needed
- 550
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- sponsor
- Chang Gung Memorial Hospital
Summary
Introduction: An optimal combination of antidiabetic drugs for diabetic patients with ischemic stroke is not well-established. The objective of this randomized trial is to evaluate whether combination of pioglitazone and a sodium glucose cotransporter 2 (SGLT-2) inhibitor, compared with a dipeptidyl peptidase-4 (DPP-4) inhibitor, reduces recurrent stroke in diabetic patients with recent ischemic stroke.
Methods and analysis: The trial is a randomized, parallel-group study conducted at 7 hospitals in Taiwan. Inclusion criteria are adult patients with a history of ischemic stroke within 3 months, diabetes mellitus with Hba1C > 7%, taking metformin currently or previously, and estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2. Eligible patients who sign the informed consent forms will be randomly assigned in a 1:1 ratio to receive either combination of pioglitazone and an SGLT2 inhibitor (empagliflozin or dapagliflozin or canagliflozin) vs. a DPP4 inhibitor. Primary outcome is recurrent stroke and the key secondary outcome is occurrence of major cardiovascular events by trial end. Additional biomarker outcomes are change in hs-CRP insulin resistance, B type natriuretic peptide, and urine albumin creatinine ratio between 6 months and baseline.
Ethics and dissemination Study protocol was approved by the Institutional Review Board of Chang Gung Memorial Hospital, Chiayi Branch, Taiwan (201702353A3, 201802340A3 and 201902176A3). All participants will be required to sign and date an informed consent form. Study findings will be disseminated via a peer-reviewed journal.
Details
| Condition | Diabetes Mellitus, Stroke |
|---|---|
| Treatment | Metformin plus Pioglitazone plus an SGLT2 inhibitor |
| Clinical Study Identifier | NCT04419337 |
| Sponsor | Chang Gung Memorial Hospital |
| Last Modified on | 24 March 2022 |
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