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, multice...
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Endocrinology Research Centre
2024-11-01
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| Series: | Сахарный диабет |
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| Online Access: | https://www.dia-endojournals.ru/jour/article/view/13236 |
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| author | O. K. Vikulova R. A. Atanesyan S. D. Movsesyan Yu. P. Kasatkina A. A. Perevyazka E. L. Zaytseva M. I. Kharakhulakh N. V. Andreeva I. A. Krivosheyeva S. V. Vorobyev T. V. Saprina D. A. Avaliani M. A. Prudnikova M. V. Shestakova N. G. Mokrysheva |
| author_facet | O. K. Vikulova R. A. Atanesyan S. D. Movsesyan Yu. P. Kasatkina A. A. Perevyazka E. L. Zaytseva M. I. Kharakhulakh N. V. Andreeva I. A. Krivosheyeva S. V. Vorobyev T. V. Saprina D. A. Avaliani M. A. Prudnikova M. V. Shestakova N. G. Mokrysheva |
| author_sort | O. K. Vikulova |
| collection | DOAJ |
| description | 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 — HbA1c change from baseline to month 6. Secondary endpoints: HbA1c change after 12 months, achievement of target HbA1c 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 HbA1c — 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 HbA1c at month 6 was -1.81%, and -2.03% at month 12. 51.3% patients achieved individual HbA1c targets at month 12, 46.7% of patients achieved the HbA1c 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. |
| format | Article |
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| institution | OA Journals |
| issn | 2072-0351 2072-0378 |
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| publishDate | 2024-11-01 |
| publisher | Endocrinology Research Centre |
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| series | Сахарный диабет |
| spelling | doaj-art-2f73a04100824746b7ba6e29179f55ea2025-08-20T01:57:15ZengEndocrinology Research CentreСахарный диабет2072-03512072-03782024-11-0127546847910.14341/DM1323611122Real-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 populationO. K. Vikulova0R. A. Atanesyan1S. D. Movsesyan2Yu. P. Kasatkina3A. A. Perevyazka4E. L. Zaytseva5M. I. Kharakhulakh6N. V. Andreeva7I. A. Krivosheyeva8S. V. Vorobyev9T. V. Saprina10D. A. Avaliani11M. A. Prudnikova12M. V. Shestakova13N. G. Mokrysheva14Endocrinology Research CentreRegional Endocrinological centerOutpatient department №25OPD №1 of Central city clinical hospitalRegional Endocrinological centerEndocrinology Research CentreEndocrinological Diagnostical centre of regional CHСlinical diagnostic center №6Clinical city hospital №1Rostov State Medical UniversitySiberian State Medical UniversityRegional Endocrinological centerJSC Sanofi RussiaEndocrinology Research CentreEndocrinology Research CentreAIM: 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 — HbA1c change from baseline to month 6. Secondary endpoints: HbA1c change after 12 months, achievement of target HbA1c 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 HbA1c — 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 HbA1c at month 6 was -1.81%, and -2.03% at month 12. 51.3% patients achieved individual HbA1c targets at month 12, 46.7% of patients achieved the HbA1c 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.https://www.dia-endojournals.ru/jour/article/view/13236diabetes mellitus type 2fixed ratio combinationinsulin glarginelixisenatidereal world settings |
| spellingShingle | O. K. Vikulova R. A. Atanesyan S. D. Movsesyan Yu. P. Kasatkina A. A. Perevyazka E. L. Zaytseva M. I. Kharakhulakh N. V. Andreeva I. A. Krivosheyeva S. V. Vorobyev T. V. Saprina D. A. Avaliani M. A. Prudnikova M. V. Shestakova N. G. Mokrysheva 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 Сахарный диабет diabetes mellitus type 2 fixed ratio combination insulin glargine lixisenatide real world settings |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | diabetes mellitus type 2 fixed ratio combination insulin glargine lixisenatide real world settings |
| url | https://www.dia-endojournals.ru/jour/article/view/13236 |
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