Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study

Hong ES, Khang AR, Yoon JW, Kang SM, Choi SH, Park KS, Jang HC, Shin H, Walford GA, Lim S.
Diabetes Obes Metab. 2012 Mar 24. Epub ahead of print. 

AIM Individuals requiring insulin therapy for type 2 diabetes often require escalation of their regimen to achieve glycaemic control. Optimal management strategies for uncontrolled type 2 diabetes would improve glycaemic control without hypoglycaemia and weight gain. This study compared the efficacy and tolerability of adding sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, and an up to 20% increase in insulin dose in patients with uncontrolled type 2 diabetes on insulin therapy. 

METHODS We conducted a 24-week, randomized, active-competitor, parallel group study in subjects with uncontrolled type 2 diabetes (HbA(1c) =7.5-11%) currently using insulin therapy. Subjects were randomly assigned to either the sitagliptin adding (100 mg daily, n=70) or an insulin-increasing arm (≥10% at week 12 and ≥10% at week 24, n=70) while continuing other medications.

RESULTS Average baseline HbA(1c) was 9.2% in both groups. HbA(1c) decreased more at 24 weeks in the sitagliptin adding than the insulin-increasing arm (-0.6±0.1% vs. -0.2±0.1%, P<0.01). Insulin was increased by 25% at 24 weeks in the insulin-increasing group. Hypoglycaemic events were less common and less severe in sitagliptin adding arm than insulin-increasing arm (7.0 vs. 14.3 events per patient-year, P<0.05). Weight was stable in the sitagliptin adding subjects (68.6±11.6 vs. 68.1±11.4kg) but increased in the insulin-increasing subjects (66.2±10.6 vs. 67.4±9.7kg, P<0.05). Other adverse events occurred at similar rates in both arms.

CONCLUSIONS Compared to a 25% increase in insulin dose, adding sitagliptin to an insulin-based regimen was more effective at lowering HbA(1c) and associated with less hypoglycaemia and weight gain over 24 weeks. 


Last Modified: 1/8/2013