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Table 3 Primary and secondary results of the GKT137831 trial

From: Evaluating the efficacy and safety of GKT137831 in adults with type 1 diabetes and persistently elevated urinary albumin excretion: a statistical analysis plan

OutcomeAnalysisMean (standard deviation)Estimated mean differencea95% Confidence IntervalP value
Intervention (GKT137831) group (n = xxx)Placebo group (n = xxx)
PrimaryEndpoint UACRIntention to treat (ITT)     
modified ITT     
Per protocol (PP)     
SecondaryMidpoint UACRIntention to treat (ITT)     
modified ITT     
Per protocol (PP)     
Endpoint eGFRIntention to treat (ITT)     
modified ITT     
Per protocol (PP)     
Midpoint eGFRIntention to treat (ITT)     
modified ITT     
Per protocol (PP)     
  1. UACR  urine albumin: creatinine ratio, eGFR estimated glomerular filtration rate
  2. a In the intervention group compared to placebo