Aim: Addition of 1-3 dose of bolus insulin is recommended by ADA/EASD guidelines when basal insulin (BI) therapy becomes insufficient for T2DM patients to achieve HbA1c target of <7%. This prospective registry study examined the effect of stepwise intensification of prandial insulin (PI) on top of BI over 48 weeks across multi-centers in Taiwan.
Method: 328 T2DM patients completed 48 weeks of stepwise intensification of PI + BI therapy (Main group). The primary objective of the study was to determine the mean change in HbA1c. Secondary objectives included; evaluation of change in FPG, 2h-PPG, PI and BI dose and the rate of HbA1c <7% achievement and hypoglycemic events. Results of BI intensification with PI were retrospectively analyzed against a BI alone group (Control group, n=113). Statistical analysis was performed using T-tests.
Result: Mean HbA1c was 9.16% in Main group at baseline. At week 48, significant difference in mean HbA1c change (-0.59 ± 1.16% vs. -0.07 ± 1.06%; p<0.0001) but not in mean FPG change (-10.99 ± 70.06 mg/dL vs. -6.53 ± 50.58 mg/dL; p=0.054) was observed between Main group and Control group; 5.49% and 2.65% (p=0.0318) of patients achieved HbA1c <7%, respectively. In Main group, mean BI dose was 26.43 ± 12.35 IU/day (p<0.05 vs. baseline); mean PI dose was 10.16 ± 7.90 IU/day (p <0.0001 vs. baseline). In Control group, mean BI dose was 24.95 ± 13.92 IU/day (p=0.0986 vs. Main group). Overall, 31 hypoglycemic episodes related to PI (9) and BI (22) use were reported as treatment-emergent adverse events in Main group. No significant difference was observed in the frequency of documented symptomatic or severe hypoglycemic episodes between Main group and Control group at baseline and at week 48.
Conclusion: This study demonstrated the introduction of stepwise intensification of prandial insulin leads to greater improvements in HbA1c levels than basal insulin monotherapy in T2DM patients in Taiwan and this effect can be maintained during the study period of 48 weeks.
Y. Hung: Advisory Panel; Self; Sanofi. Y. Huang: Research Support; Self; Sanofi. H. Chen: Research Support; Self; Sanofi. R. Liu: Research Support; Self; Sanofi. N.C. Yu: None. H. Lam: None. C. Huang: Research Support; Self; Sanofi. C. Chen: Research Support; Self; Sanofi. P. Hsiao: Advisory Panel; Self; Sanofi. H. Chen: None. M. Chien: Research Support; Self; Sanofi. T. Lee: None. C.Y. Yang: None. C. Chen: Advisory Panel; Self; Sanofi-Aventis. S. Tu: None. H. Chen: None. W. Sheu: Advisory Panel; Self; Sanofi.