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. 2019 Oct 9;2019(10):CD010693. doi: 10.1002/14651858.CD010693.pub5

Kernan 2003.

Methods A randomised, double‐blind, placebo‐controlled trial to test the effect of pioglitazone compared with placebo for improving insulin sensitivity among non‐diabetic patients with a recent TIA or non‐disabling ischaemic stroke
Participants Non‐diabetic men and women aged > 45 years with TIA or non‐disabling ischaemic stroke were included. 20 eligible patients from 3 hospitals were randomised as 1:1 into the trial.
Interventions Pioglitazone 45 mg per day or placebo was given for 3 months.
Outcomes Mean proportional changes in insulin sensitivity; mean C‐reactive protein concentration; adverse events
Notes A repeated oral glucose tolerance test was done at the endpoint of the 3 months of therapy. The mean age was 66 years among participants assigned to pioglitazone and 67 years among participants assigned to placebo.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A master schedule of computer‐generated random treatment assignments (placebo or pioglitazone) was stored at the investigational pharmacy at Yale‐New Haven hospital.
Allocation concealment (selection bias) Low risk After screening for eligibility, a research associate contacted the investigational pharmacist, who assigned the participant to the next available treatment as specified by the master schedule.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants were blinded to treatment assignment throughout the study.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Research staff and investigators were blinded to treatment assignment throughout the study.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No participant permanently discontinued the treatment.
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported.
Other bias Low risk The study was funded by an investigator‐initiated grant from Takeda Pharmaceuticals North America. Takeda had no involvement in data collection, data analysis, or report composition. By contract, Takeda could not suppress publication of this report.