Real-world effectiveness and safety of fixed-ratio combination insulin glargine 100 u/ml plus lixisenatide in adults with type 2 diabetes (T2DM): subanalysis of the international, multicentre, prospective observational study SUCCESS in the Russian population

AIM: To evaluate the impact a fixed-ratio combination of insulin glargine(100U/ml) and lixisenatide(iGlarLixi) on the glycemic control in Russian study T2D population uncontrolled on OAD ± insulin therapy in real-world settings.

MATERIALS AND METHODS: The Russian subanalysis of international, multicentre, prospective, observational SUCCESS study included 160 T2DM patients who had initiated iGlarLixi within 1 month prior to study inclusion from 11 regions of the Russian Federation. The primary endpoint — HbA_1c change from baseline to month 6. Secondary endpoints: HbA_1c change after 12 months, achievement of target HbA_1c levels after 6 and 12 months; change in FPG and PPG, change in body weight after 6 and 12 months, iGlarLixi dose dynamics. Safety endpoints: adverse events, serious adverse events, adverse events of special interest, frequency of hypoglycemia during the study period.

RESULTS: The average age of patients in the Russian population was 60.8±9.4 years; average duration of T2DM was 11.4 years, mean HbA_1c — 9.3±1.5%; mean BMI 33.3 kg/m². Prior to the study, most patients were on 2 (36.3%) and 3 OADs (27.5%), 32.5% — on insulin therapy. The mean change of HbA_1c at month 6 was -1.81%, and -2.03% at month 12. 51.3% patients achieved individual HbA_1c targets at month 12, 46.7% of patients achieved the HbA_1c target without hypoglycemia and weight gain. The decrease of body weight in 12 months was -3.3±4.4 kg. During the study period, 17 cases of hypoglycemia were recorded (0.11 events per patient-year); 1 severe hypoglycemia (0.01 events per patient-year). The total number of adverse events (AEs) was 43(26.9%), serious AEs - 10 (6.3%).

CONCLUSION: According to the results of this prospective real world sub-group analysis, initiation of iGlarLixi in Russian adults with T2DM uncontrolled on OADs ± insulin significantly improves glycemic control with low risk of hypoglycemia and no body weight increase.

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