Outcomes and assessments
hypoglycemia, T2DM
HYPOGLYCEMIA, EVENTS, SECONDARY, ADVERSE EVENTS
The primary efficacy endpoint was to evaluate the HbA1c from baseline to Week 24 in T2DM patients treated with fotagliptin 12 mg/day, in parallel control with alogliptin and placebo. The secondary endpoints were change in HbA1c from baseline to Week 52; change in FBG from baseline to Week 52; occurrence of hypoglycemia from baseline to Week 52; change in bodyweight from baseline to Week 52. All adverse events were followed up by investigators and have been sufficiently characterised. The following adverse events were to be reported: serious adverse events occured in more than 2% of the patients in either treatment group; any adverse events occurred in more than 5% patients in either treatment group; any other safety events of special interest.