Table 3.

Study endpoints

Primary endpoint

Change in HbA1c from baseline to the end of the study

Secondary endpoints

Change in iron status from baseline to the end of the study as measured by hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin, % hypochromic cells, reticulocyte hemoglobin content, ferritin, transferrin, transferrin saturation (TSAT), soluble transferrin receptor (sTFR), serum iron, hepcidin Change in metabolic status from baseline to the end of the study as measured by fasting blood glucose and fructosamine Change in insulin dosage used per application from baseline to the end of the study Reliability of HbA1c measurements Change in quality of life from baseline to the end of treatment as assessed by Euro-QoL (EQ5D) questionnaire