ENTIRE: real clinical practice study on alogliptin application in the treatment of patients with type 2 diabetes mellitus in the Russian Federation

M.V. Shestakova¹, V.A. Kachko<sup>2

1</sup> National Medical Research Center of Endocrinology, Moscow
² “LLC Takeda Pharmaceuticals”, Moscow

Aim: the main study objective was to evaluate the effectiveness of the drug Vipidia^® (international non-proprietary name — alogliptin; pharmacotherapeutic group — glucose-lowering drug — dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor)) in relation to the dynamics of glycated hemoglobin (HbA1c) level in patients with type 2 diabetes mellitus (DM2) in real clinical practice.
Patients and Methods: a local multicenter observational non-interventional prospective study was conducted, which included 1399 patients with DM2 observed in 53 research centers of the Russian Federation. The study duration lasted for 6 months (24 weeks). The study included patients aged 18 or older with first diagnosed DM2 or patients who did not achieve their glycemic indices. Prior to the study, the main exclusion criteria were contraindications to the alogliptin use or drugs of the DPP-4 inhibitor group or agonists of type 1 glucagon-like peptide (aGPP-1) receptors for 3 months. Alogliptin was prescribed by the attending physicians in accordance with the indications. INN, trade name, dosage regimen, and treatment duration were recorded in the case of combined treatment for all concomitant drugs for DM2. Before and after 3 and 6 months from the therapy beginning with alogliptin, HbA1c level, glycemic indices, lipid level, and patient body weight were recorded.
Results: the average decrease in HbA1c level by the end of the study was -1.2±1.0 %. 52% of patients reached HbA1c<7.0%. The decrease level in HbA1c depended on the HbA1c initial level. The most pronounced decrease in HbA1c achieved -2.5±1.4 in the patient’s subgroup with the highest baseline values (HbA1c≥9%, n=248 [17.8% of the whole sample]). HbA1c values decreased throughout the observation period. So, alogliptin use was characterized by a favorable safety profile.
Conclusion: the study results confirm the efficacy and safety of alogliptin use in patients with DM2 in real clinical 

Keywords: type 2 diabetes mellitus, DPP-4 inhibitors, alogliptin, Vipidia, glycated hemoglobin.
For citation: Shestakova M.V., Kachko V.A. ENTIRE: real clinical practice study on alogliptin application in the treatment of patients with type 2 diabetes mellitus in the Russian Federation. RMJ. 2019;8(I):1–10.