Pioglitazone and SGLT2 Inhibitors vs. DPP4 Inhibitors in Patients With Stroke

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    550
  • sponsor
    Chang Gung Memorial Hospital
Updated on 24 March 2022
diabetes
cardiovascular disease
insulin
diabetes mellitus
type 2 diabetes mellitus
insulin resistance
glomerular filtration rate
ischemic stroke
metformin
hemoglobin a1c
glycosylated hemoglobin
pioglitazone
antidiabetic agents
dipeptidyl peptidase-4 inhibitor

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 IdentifierNCT04419337
SponsorChang Gung Memorial Hospital
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Ischemic stroke within 3 months of randomization
Type 2 diabetes mellitus and Hba1C > 7.0% and under metformin therapy currently or previously
Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2
Age ≥ 20 y at study entry
Ability and willingness to provide informed consent

Exclusion Criteria

History of congestive heart failure (NYHA class 1-4)
History of bladder cancer
History of repeated (> 2 episodes) urinary tract infection or genital tract infection
Irreversible medical conditions with predicted survival < 1 years
Current use of an insulin
Current use of a glucagon-like peptide-1 receptor agonist
Current use of pioglitazone or an SGLT-2 inhibitor
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