Initial investigation of efficacy and safety of a new dipeptidyl peptidase-4 inhibitor, gosogliptin, for type 2 diabetes in Russia

Abstract

Current treatment strategies for type 2 diabetes mellitus (T2DM) are based on using safe and effective hypoglycaemic agents for preventing diabetic vascular complications and reducing the risks associated with weight gain and hypoglycaemia. These goals may be achieved using new agents with a fundamentally new mechanism of action: inhibitors of dipeptidyl peptidase-4 (DPP-4i). However, the wide distribution of this enzyme in the body is associated with extraglycaemic DPP-4i effects, both positive and negative. Thus, it is important to develop and implement new DPP-4i agents for clinical practice. Aim. To investigate the efficacy and safety of a novel DPP-4i, gosogliptin, for use as monotherapy and in combination with metformin vs. vildagliptin as monotherapy and in combination with metformin for patients with drug-naïve type 2 diabetes in a multicentre, open, randomized clinical trial. Materials and methods. We enrolled 299 drug-naïve type 2 diabetes patients; 149 patients were randomized to receive gosogliptin and 150 patients received tovildagliptin. These groups had similar baseline characteristics. After randomization, 12 weeks of monotherapy was administered to both groups. Further, it was decided to continue the monotherapy or in combination with metformin, depending on each patient. The results after the first 12 weeks are presented in this paper. Results. After 12 weeks of monotherapy, HbA1c levels decreased significantly from 8.61% to 7.41% (p <0.05) in the gosogliptin group and from 8.7% to 7.34% (p <0.05) in the vildagliptin group; these changes were not significantly different between these groups. Target HbA1c of ≤7.0% was achieved for 59 patients (41%) who took gosogliptin and 66 patients (44%) who took vildagliptin (p=0.53). After 12 weeks of monotherapy, 11 episodes of mild hypoglycaemia occurred (7 on gosogliptin and 4 on vildagliptin), without clinical manifestations of blood glucose levels of <3.9 mmol/l based on metre readings. Only 14 adverse events (7 patients in each group) were assessed as 'related to' or 'probably related to' gosogliptin or vildagliptin. Conclusion. Our preliminary monotherapy study showed comparable efficacy and safety profiles for gosogliptin and vildagliptin.