A Phase 2 interventional study of Metformin plus Pioglitazone plus an SGLT2 inhibitor in Diabetes Mellitus and Stroke, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Chang Gung Memorial Hospital · Phase 2, Interventional, and Treatment
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 change in HbA1C between 6 months and baseline in active vs comparator groups. 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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
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Exclusion Criteria:
metformin+pioglitazone+an SGLT2 inhibitor
Drug: Metformin plus Pioglitazone plus an SGLT2 inhibitor
metformin + DPP4 inhibitors
Drug: Metformin plus Pioglitazone plus an SGLT2 inhibitor
Patients assigned to active group will stop their prior oral antidiabetic drugs and receive combination of metformin, pioglitazone, and an SGLT2 inhibitor (empagliflozin or dapagliflozin or canagliflozin) and dose will be adjusted by their physicians.
HbA1C
blood test to evaluate glycemic control
Time frame: 6 months from baseline in active vs control arms
UACR
to evaluate microalbuminuria
Time frame: 6 months from randomization in active vs control arms
hs-CRP
to evaluate hs-CRP in active vs control arms
Time frame: 6 months from randomization
NT-proBNP
to evaluate NT-proBNP in active vs control arms
Time frame: 6 months from randomization
insulin resistance
Insulin resistance will be evaluated by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: 6 months from randomization
Plan to share: No
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital