Practical Applications of Russian DPP4 Inhibitor Gosogliptin in “Palitra” Large-Scale Observational Study

BACKGROUND: To date, the results of Metformin, Gosogliptin and combination thereof have not been studied on a large patient population with type 2 diabetes mellitus (DM2), including comorbid patients, in real clinical settings in the Russian Federation.

AIM: The aim is to evaluate the efficacy, safety, treatment adherence and satisfaction of patients with DM2 with the use of Metformin and Gosogliptin sugar-lowering drugs and combination thereof in routine clinical practice.

MATERIALS AND METHODS: The nationwide PALITRA multicenter observational study was conducted among patients with DM2 who were prescribed therapy with Metformin or Gosogliptin or combination thereof in everyday clinical practice. Groups were formed according to the sugar-lowering drug administered; a total of 5741 patients aged 18 to 65 years with DM2 and a wide comorbidity profile participated. The observation period was 6 months. Body weight, body mass index (BMI), blood pressure (BP), glycated hemoglobin (HbA_1c) level, glycemic parameters, and biochemical parameters (ALT, AST and plasma creatinine) were recorded initially and 3 and 6 months after the initiation of therapy with the study drugs. Adherence to therapy and patient and physician satisfaction with the treatment were assessed using Likert scale.

RESULTS: HbA1c level decreased by 1.03% in the Metformin monotherapy group and by 0.95% in the Gosogliptin monotherapy and Metformin and Gosogliptin combination therapy groups by Week 24. By the end of the study, 49.6% of patients with DM2 reached the target HbA_1c level (<7.0%). The proportion of patients with HbA_1c level <7.0% was 61.0% in the Metformin group, 47.75% and 47.2% in the Gosogliptin and Metformin/Gosogliptin dual combination therapy groups, respectively. The incidence of hypoglycemic episodes was very low throughout the whole period of observation, during which body weight decreased slightly. High satisfaction of patients and physicians with DM2 treatment was shown. This was reflected by high Likert scale scores.

CONCLUSION: It has been proved that Metformin, Gosogliptin and the combination of Metformin and Gosogliptin were highly effective and safe (low incidence of hypoglycemia and no effect on body weight), and patients and physicians had been satisfied with the sugar-lowering therapy in a sufficient number of Russian patients with DM2 and a wide comorbidity profile.