Antidiabetic Triple Therapy Effects on Surrogate Tests After Stroke

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    200
  • sponsor
    Chang Gung Memorial Hospital
Updated on 25 January 2021
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

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.

Details
Condition Diabetes Mellitus, Cerebrovascular accident, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Stroke, diabetes mellitus (dm), cerebrovascular accidents, strokes, cerebral
Treatment Metformin plus Pioglitazone plus an SGLT2 inhibitor
Clinical Study IdentifierNCT04419337
SponsorChang Gung Memorial Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 20 yrs and 99 yrs?
Gender: Male or Female
Do you have any of these conditions: Cerebrovascular accident or Diabetes Mellitus Types I and II or Diabetes Mellitus or Stroke or Diabetes Prevention or Diabetes (Pediatric)?
Do you have any of these conditions: Stroke or Diabetes Mellitus or Cerebrovascular accident or Diabetes (Pediatric) or cerebrovascular accidents or Diabetes Prevention or diabetes mellit...?
Ischemic stroke within 6 months of randomization
Type 2 diabetes mellitus and Hba1C > 7.0% and under metformin currently or previously with or without other antidiabetic drugs
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
History of amputation
Irreversible medical conditions with predicted survival < 1 years
ALT > 100 mg/dl
Currently use insulin injection to control blood glucose
Currently use Glucagon-like peptide-1 receptor agonist to control blood glucose
Currently use pioglitazone or SGLT-2 inhibitor
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