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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

Outcome

Analysis

Mean (standard deviation)

Estimated mean differencea

95% Confidence Interval

P value

Intervention (GKT137831) group (n = xxx)

Placebo group (n = xxx)

Primary

Endpoint UACR

Intention to treat (ITT)

     

modified ITT

     

Per protocol (PP)

     

Secondary

Midpoint UACR

Intention to treat (ITT)

     

modified ITT

     

Per protocol (PP)

     

Endpoint eGFR

Intention to treat (ITT)

     

modified ITT

     

Per protocol (PP)

     

Midpoint eGFR

Intention 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
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Trials

ISSN: 1745-6215