Efficacy and safety of coadministration of sitagliptin with insulin glargine in type 2 diabetes.

BackgroundThe aim of the randomized present study was to compare the therapeutic efficacy and safety of a combination of sitagliptin, a dipeptidyl peptidase (DPP)-4 inhibitor, plus insulin glargine (GL+sita) with that of premixed insulin aspart 30 (NOV) for type 2 diabetes (T2D) patients controlled with oral hypoglycemic drugs (HbA1c 7%-9%). MethodsSixty-five patients were randomized (1:1) to the GL+sita (n=33) and NOV (n=32) groups and were treated with the combination regimen or premixed insulin twice a day for 16weeks. The primary endpoint was mean change in HbA1c. Secondary endpoints included fasting blood glucose, blood glucose profiles (seven time points), rate of achieving target HbA1c (<7% or 6.5%), insulin dose, incidence of hypoglycemia, and body weight. ResultsAfter 16weeks, there was no significant difference in HbA1c between the two groups, although more patients achieved HbA1c <7.0% in the GL+sita group. There was a significant difference in body weight changes between the GL+sita and NOV groups (-0.45 vs 1.52kg, respectively; P<0.001). Mean plasma glucose and the mean amplitude of glycemic excursion were significantly lower in the GL+sita than NOV group (P<0.005), as was the incidence of symptomatic hypoglycemia (2.85% vs. 13.3%, respectively; P<0.001). ConclusionThe combination of GL+sita greatly improved HbA1c in T2D patients (HbA1c 7%-9%) with an efficacy that was equal to that of premixed insulin. Thus, GL+sita treatment is a viable option for patients who fail to achieve glycemic control using oral hypoglycemic drugs.