The results of DINASTIYA study - Diabeton MB: the observational program among the patients with type 2 diabetes mellitus under conditions of routine clinical practice

Abstract

The aim of the DINASTIYA study (the name of this study is the acronym composed of the selected letters from the Russian title: "DIabeton MB - Nablyudatel'naya programma sredi patsientov c Sakharnym diabeTom 2 tipa v uslovIYAkh rutinnoy praktiki") was to estimate the possibility of achieving the targeted parameters of glycemic control by means of the step by step increase of diabeton MB dose and to evaluate the safety of this therapy under conditions of routine clinical practice. Materials and methods: The program involved 2213 patients with poorly controlled type 2 diabetes mellitus who had been treated with diabeton MB during the preceding period (30-90 mg/day in the form of monotherapy or in combination with the maximum tolerated dose of metformin). The dose of diabeton MB was titrated under control of glycemia during 3 months. The combined treatment including metformin was given to 70% of the patients. The average daily dose of diabeton MB by the end of the study was 90.9 mg. As many as 70% of the petients received diabeton MB at a daily dose of 90-120 mg. Results: The statistically significant reduction of the fasting blood glucose (FG) level from 8.3±1.6 mmol/l to 6.2±0.9 mmol/l and postprandial glycemia (PPG) from 10.5±2.1 mmol/l to 7.6±1.0 mmol/l was documented within 3 month after the onset of therapy. The targeted FG and PPG levels (<6.5 mmol/l and <8.0 mmol/l) were achieved in 68.9% and 71.5% of the patients respectively. Simultaneously, the body weight decreased (by 1 kg on the average) and arterial pressure fell down (SAP - 8.4 and DAP - 3.9 mm HG respectively). Conclusion: The strategy of management of type 2 diabetes mellitus based on the step by step increase of the dose of diabeton MB allows the targeted parameters of glycemic control to be achieved in combination with the good tolerability of the treatment and the low risk of development of hypoglycemia.