Abstract
Objectives: The aim of this study is to investigate ipragliflozin as an initial type 2 diabetes
(T2DM) drug.
Methods: Ipragliflozin 25–50 mg/day monotherapy was performed with drug naïve subjects with
T2DM (n=31). As a comparator, 12.5–25 mg/day alogliptin monotherapy was undertaken
(n=32). At 3 months, levels of metabolic parameters were compared with those at baseline.
Findings: 4 subjects discontinued ipragliflozin due to intolerance or adverse events, while
none dropped out with alogliptin. At 3 months, similar decreases of HbA1c levels were
observed with these 2 drugs (10.21–8.31%, p<0.00001, with ipragliflozin, and 10.08–8.25%,
p<0.00001, with alogliptin), however fasting blood glucose (FBG) levels decreased
with significant inter-group differences (− 23.5% with iprgliflozin and – 10.8% with
alogliptin). While similar increases of homeostasis model assessment (HOMA)-B levels
were observed with these 2 drugs, HOMA-R levels significantly decreased only with
ipragliflozin (−19.4%, p<0.02). Un-correlative link between HOMA-R and HOMA-B levels
at baseline became significantly correlative (R=0.6017, p<0.001) only with ipragliflozin.
Significant reductions of body mass index (BMI, −2.6%, P<0.05) were observed with
ipragliflozin, however, no correlations between the changes of BMI and those of HbA1c
or FBG were noted.
Conclusions: These results suggest that ipragliflozin has good glycemic efficacy as an initial
therapy in subjects with T2DM, although certain adverse events or tolerability issues
are concerned. It improves insulin sensitivity and may restore the impaired beta-cell
function. However body weight reduction with ipragliflozin is not associated with
its glycemic efficacy.
Key words
SGLT-2 inhibitors - ipragliflozin - initial therapy - insulin resistance - beta-cell
function