Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study
Article first published online: 18 APR 2012
© 2012 Blackwell Publishing Ltd
Diabetes, Obesity and Metabolism
Volume 14, Issue 9, pages 795–802, September 2012
How to Cite
Hong, E. S., Khang, A. R., Yoon, J. W., Kang, S. M., Choi, S. H., Park, K. S., Jang, H. C., Shin, H., Walford, G. A. and Lim, S. (2012), Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study. Diabetes, Obesity and Metabolism, 14: 795–802. doi: 10.1111/j.1463-1326.2012.01600.x
- Issue published online: 26 JUL 2012
- Article first published online: 18 APR 2012
- Accepted manuscript online: 24 MAR 2012 10:39AM EST
- Date submitted 11 January 2012; date of first decision 14 February 2012; date of final acceptance 19 March 2012
- β-cell function;
- weight gain
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 [haemoglobin A1c (HbA1c) = 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 HbA1c was 9.2% in both groups. HbA1c 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 ± 11.4 kg) but increased in the insulin-increasing subjects (66.2 ± 10.6 vs. 67.4 ± 9.7 kg, 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 HbA1c and associated with less hypoglycaemia and weight gain over 24 weeks. Clinical trial number: NCT01100125.