Aim: To study efficacy and safety of rosiglitazone + NPH insulin combined treatment in patients with type 2 diabetes mellitus (DM).
Material and methods: The trial included 43 patients with DM aged 44-75 on NPH insulin. The patients were divided into two groups. The study group received NPH insulin + a single morning dose of 4 mg/day rosiglitazone, the control group received NPH insulin only. The treatment lasted 24 weeks.
Results: 24-week therapy in the study group lowered HbA(1c) from 8.16 +/- 0.23 to 6.82 +/- 0.18% (p<0.05), fasting glycemia--from 9.68 +/- 0.48 to 6.4 +/- 0.32 mmol/l, postprandial glycemia--from 12.3 +/- 0.44 to 8.4 +/- 0.56 mmol/l, HOMA-IR index--from 7.65 +/- 1.12 to 4.26 +/- 0.59. In group 2 HbAlc--from 7.84 +/- 0.15 to 7.49 +/- 0.17 (p<0.05), from 9.21 +/- 0.65 to 8.38 +/- 0.50 mmol/l, 11.92 +/- 0.53 to 9.97 +/- 0.45 mmol/l, 6.77 +/- 0.79 to 5.73 +/- 0.63. The combined treatment produced positive changes in lipid metabolism: total cholesterol decreased from 6.37 +/- 0.36 to 5.67 +/- 0.32 mmol/l (p<0.005), TG--from 2.46 +/- 0.64 mmol/l to 1.82 +/- 0.46 mmol/l (p<0.005), LDLP--from 3.99 +/- 0.40 to 3.58 +/- 0.37 mmol/l. Need in insulin diminished by 10%.
Conclusion: Treatment results showed that administration of rosiglitazone in combination with NPH insulin has a good safety and tolerance profile in type 2 DMp atients.