ATOS study: effectiveness and safety of insulin glargine 300 U/mL in the real world clinical practice in insulin-naïve type 2 diabetic patients in the Russian Federation
Rationale: Basal insulin glargine 300 U/mL (Gla-300) is a second-generation basal insulin analogue that has comparable efficacy and lower variability compared to the first generation long-acting insulin analogue glargine 100 U/mL. Aim: To assess the effectiveness and safety of Gla-300 in insulin-...
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| Format: | Article |
| Language: | Russian |
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MONIKI
2022-10-01
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| Series: | Alʹmanah Kliničeskoj Mediciny |
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| Online Access: | https://almclinmed.ru/jour/article/viewFile/1723/1479 |
| _version_ | 1811245687524818944 |
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| author | Gagik R. Galstyan |
| author_facet | Gagik R. Galstyan |
| author_sort | Gagik R. Galstyan |
| collection | DOAJ |
| description | Rationale: Basal insulin glargine 300 U/mL (Gla-300) is a second-generation basal insulin analogue that has comparable efficacy and lower variability compared to the first generation long-acting insulin analogue glargine 100 U/mL.
Aim: To assess the effectiveness and safety of Gla-300 in insulin-nave type 2 diabetic patients in the real world practice in Russia.
Materials and methods: ATOS (NCT03703869) was a 12-month, prospective observational international multicenter study. The study included 4422 adults ( 18 years) with uncontrolled type 2 diabetes (HbA1c 7 and 11%) with 1 oral anti-hyperglycemic drug and for whom the treating physician had decided to add Gla-300. We performed a post-hoc sub-analysis of the study participants recruited in Russia.
Results: The Russian study group included 1493 patients receiving Gla-300. At 6 months, 25.9% of the patients achieved their predefined individualized HbA1c target and 53.3% achieved their HbA1c target at month 12. Their mean ( SD) HbA1c level decreased from 9.3 0.9% at baseline to 7.6 0.7% and 7.2 0.7 at months 6 and 12. The incidence of hypoglycemia was generally low; overall, severe hypoglycemia was reported only in 0.07% and 0.13% of the patients at 6 and 12 months. The baseline average daily dose of Gla-300 was 13.2 4.9 Units; it to 23.6 9.1 and 26.0 9.8 Units at months 6 and 12.
Conclusion: In the real world setting, initiation of insulin Gla-300 in type 2 diabetic patients who had been out of their target glucose range with oral hypoglycemic agents is associated with improved glycemic control and low risk of hypoglycemia. |
| first_indexed | 2024-04-12T14:43:05Z |
| format | Article |
| id | doaj.art-05072a42c1ec4f35b0c162ecdd2d8ae8 |
| institution | Directory Open Access Journal |
| issn | 2072-0505 2587-9294 |
| language | Russian |
| last_indexed | 2024-04-12T14:43:05Z |
| publishDate | 2022-10-01 |
| publisher | MONIKI |
| record_format | Article |
| series | Alʹmanah Kliničeskoj Mediciny |
| spelling | doaj.art-05072a42c1ec4f35b0c162ecdd2d8ae82022-12-22T03:28:45ZrusMONIKIAlʹmanah Kliničeskoj Mediciny2072-05052587-92942022-10-0150314915710.18786/2072-0505-2022-50-027877ATOS study: effectiveness and safety of insulin glargine 300 U/mL in the real world clinical practice in insulin-naïve type 2 diabetic patients in the Russian FederationGagik R. Galstyan0https://orcid.org/0000-0001-6581-4521Endocrinology Research CentreRationale: Basal insulin glargine 300 U/mL (Gla-300) is a second-generation basal insulin analogue that has comparable efficacy and lower variability compared to the first generation long-acting insulin analogue glargine 100 U/mL. Aim: To assess the effectiveness and safety of Gla-300 in insulin-nave type 2 diabetic patients in the real world practice in Russia. Materials and methods: ATOS (NCT03703869) was a 12-month, prospective observational international multicenter study. The study included 4422 adults ( 18 years) with uncontrolled type 2 diabetes (HbA1c 7 and 11%) with 1 oral anti-hyperglycemic drug and for whom the treating physician had decided to add Gla-300. We performed a post-hoc sub-analysis of the study participants recruited in Russia. Results: The Russian study group included 1493 patients receiving Gla-300. At 6 months, 25.9% of the patients achieved their predefined individualized HbA1c target and 53.3% achieved their HbA1c target at month 12. Their mean ( SD) HbA1c level decreased from 9.3 0.9% at baseline to 7.6 0.7% and 7.2 0.7 at months 6 and 12. The incidence of hypoglycemia was generally low; overall, severe hypoglycemia was reported only in 0.07% and 0.13% of the patients at 6 and 12 months. The baseline average daily dose of Gla-300 was 13.2 4.9 Units; it to 23.6 9.1 and 26.0 9.8 Units at months 6 and 12. Conclusion: In the real world setting, initiation of insulin Gla-300 in type 2 diabetic patients who had been out of their target glucose range with oral hypoglycemic agents is associated with improved glycemic control and low risk of hypoglycemia.https://almclinmed.ru/jour/article/viewFile/1723/1479glucose controlhypoglycemiainsulin analoguetype 2 diabetesglargine 300 u/ml |
| spellingShingle | Gagik R. Galstyan ATOS study: effectiveness and safety of insulin glargine 300 U/mL in the real world clinical practice in insulin-naïve type 2 diabetic patients in the Russian Federation Alʹmanah Kliničeskoj Mediciny glucose control hypoglycemia insulin analogue type 2 diabetes glargine 300 u/ml |
| title | ATOS study: effectiveness and safety of insulin glargine 300 U/mL in the real world clinical practice in insulin-naïve type 2 diabetic patients in the Russian Federation |
| title_full | ATOS study: effectiveness and safety of insulin glargine 300 U/mL in the real world clinical practice in insulin-naïve type 2 diabetic patients in the Russian Federation |
| title_fullStr | ATOS study: effectiveness and safety of insulin glargine 300 U/mL in the real world clinical practice in insulin-naïve type 2 diabetic patients in the Russian Federation |
| title_full_unstemmed | ATOS study: effectiveness and safety of insulin glargine 300 U/mL in the real world clinical practice in insulin-naïve type 2 diabetic patients in the Russian Federation |
| title_short | ATOS study: effectiveness and safety of insulin glargine 300 U/mL in the real world clinical practice in insulin-naïve type 2 diabetic patients in the Russian Federation |
| title_sort | atos study effectiveness and safety of insulin glargine 300 u ml in the real world clinical practice in insulin naive type 2 diabetic patients in the russian federation |
| topic | glucose control hypoglycemia insulin analogue type 2 diabetes glargine 300 u/ml |
| url | https://almclinmed.ru/jour/article/viewFile/1723/1479 |
| work_keys_str_mv | AT gagikrgalstyan atosstudyeffectivenessandsafetyofinsulinglargine300umlintherealworldclinicalpracticeininsulinnaivetype2diabeticpatientsintherussianfederation |