Insulin degludec: a new basal insulin analogue with an ultra-long duration of action. Safety and efficacy in Russian patients with diabetes
Aims. Insulin degludec (IDeg) is a novel insulin analogue that, following subcutaneous injection, forms soluble multihexamers, resulting in an ultra-long duration of action, which is two-fold longer than that of insulin glargine (IGlar). We present data from Russian cohorts of two multinational, ope...
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Endocrinology Research Centre
2015-12-01
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| Series: | Сахарный диабет |
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| Online Access: | https://www.dia-endojournals.ru/jour/article/view/7694 |
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| author | Marina Vladimirovna Shestakova Michail Vladimirovich Antciferov Alexander Yur'evich Mayorov Luydmila Alexandrovna Ruyatkina Ludmila Alexandrovna Suplotova Sergey Anatol'evich Dogadin Nikolay Borisovich Lebedev Yana Gennadievna Alekseeva |
| author_facet | Marina Vladimirovna Shestakova Michail Vladimirovich Antciferov Alexander Yur'evich Mayorov Luydmila Alexandrovna Ruyatkina Ludmila Alexandrovna Suplotova Sergey Anatol'evich Dogadin Nikolay Borisovich Lebedev Yana Gennadievna Alekseeva |
| author_sort | Marina Vladimirovna Shestakova |
| collection | DOAJ |
| description | Aims. Insulin degludec (IDeg) is a novel insulin analogue that, following subcutaneous injection, forms soluble multihexamers, resulting in an ultra-long duration of action, which is two-fold longer than that of insulin glargine (IGlar). We present data from Russian cohorts of two multinational, open-label, treat-to-target phase 3 trials that investigated the efficacy and safety of IDeg and IGlar administered once daily.Materials and methods. The BEGIN Basal–Bolus Type 1 trial was a 52-week study comparing IDeg (n = 45) to IGlar (n = 16), both 100 U/mL, and in combination with insulin aspart in patients with type 1 diabetes (T1D). The BEGIN LOW VOLUME trial compared IDeg (200 U/mL; n = 27) to IGlar (100 U/mL; n = 28) over 26 weeks in insulin-naïve patients with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs. The primary outcome of both studies was the non-inferiority of IDeg to IGlar, as assessed by HbA1c level reduction at the trial end.Results. In patients with T1D, HbA1c level reductions at the trial end were 0.42% (IDeg) and 0.22% (IGlar). The rates of confirmed hypoglycaemia (plasma glucose level < 3.1 mmol/L or severe) were lower in IDeg than in IGlar [17.83 vs. 22.87 events/patient/year exposure (PYE), respectively]. The rates of nocturnal-confirmed hypoglycaemia were lower for IDeg than for IGlar (2.24 vs. 4.77 events/PYE, respectively). Severe episodes occurred in >10% of patients in both treatment groups, with rates per PYE of 0.12 (IDeg) and 0.06 (IGlar). In patients with T2D, HbA1c levels decreased by 1.17% (IDeg) and 1.26% (IGlar) at the trial end. The rates of confirmed hypoglycaemia were comparable in IDeg and IGlar (0.52 vs. 0.44 events/PYE, respectively). The rates of nocturnal-confirmed hypoglycaemia were lower for IDeg than for IGlar (0.18 vs. 0.28 events/PYE, respectively). No severe episode occurred in either treatment group. In both studies, IDeg was well tolerated with no difference in safety between the two analogues investigated.Conclusions. In both T1D and T2D, IDeg provided similar glycaemic control to IGlar, with a lower risk of nocturnal hypoglycaemia. |
| format | Article |
| id | doaj-art-addf81b97bd5452b82b135e445ce89a8 |
| institution | OA Journals |
| issn | 2072-0351 2072-0378 |
| language | English |
| publishDate | 2015-12-01 |
| publisher | Endocrinology Research Centre |
| record_format | Article |
| series | Сахарный диабет |
| spelling | doaj-art-addf81b97bd5452b82b135e445ce89a82025-08-20T01:57:09ZengEndocrinology Research CentreСахарный диабет2072-03512072-03782015-12-0118413014110.14341/DM76947276Insulin degludec: a new basal insulin analogue with an ultra-long duration of action. Safety and efficacy in Russian patients with diabetesMarina Vladimirovna Shestakova0Michail Vladimirovich Antciferov1Alexander Yur'evich Mayorov2Luydmila Alexandrovna Ruyatkina3Ludmila Alexandrovna Suplotova4Sergey Anatol'evich Dogadin5Nikolay Borisovich Lebedev6Yana Gennadievna Alekseeva7Endocrinology Research Centre; Sechenov First Moscow State Medical UniversityMoscow City Endocrinologocal DispensaryEndocrinology Research Centre; Sechenov First Moscow State Medical UniversityNovosibirsk State Medical UniversityTyumen State Medical UniversityKrasnoyarsk State Medical University; Regional clinical hospital, KrasnoyarskNovo NordiskNovo NordiskAims. Insulin degludec (IDeg) is a novel insulin analogue that, following subcutaneous injection, forms soluble multihexamers, resulting in an ultra-long duration of action, which is two-fold longer than that of insulin glargine (IGlar). We present data from Russian cohorts of two multinational, open-label, treat-to-target phase 3 trials that investigated the efficacy and safety of IDeg and IGlar administered once daily.Materials and methods. The BEGIN Basal–Bolus Type 1 trial was a 52-week study comparing IDeg (n = 45) to IGlar (n = 16), both 100 U/mL, and in combination with insulin aspart in patients with type 1 diabetes (T1D). The BEGIN LOW VOLUME trial compared IDeg (200 U/mL; n = 27) to IGlar (100 U/mL; n = 28) over 26 weeks in insulin-naïve patients with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs. The primary outcome of both studies was the non-inferiority of IDeg to IGlar, as assessed by HbA1c level reduction at the trial end.Results. In patients with T1D, HbA1c level reductions at the trial end were 0.42% (IDeg) and 0.22% (IGlar). The rates of confirmed hypoglycaemia (plasma glucose level < 3.1 mmol/L or severe) were lower in IDeg than in IGlar [17.83 vs. 22.87 events/patient/year exposure (PYE), respectively]. The rates of nocturnal-confirmed hypoglycaemia were lower for IDeg than for IGlar (2.24 vs. 4.77 events/PYE, respectively). Severe episodes occurred in >10% of patients in both treatment groups, with rates per PYE of 0.12 (IDeg) and 0.06 (IGlar). In patients with T2D, HbA1c levels decreased by 1.17% (IDeg) and 1.26% (IGlar) at the trial end. The rates of confirmed hypoglycaemia were comparable in IDeg and IGlar (0.52 vs. 0.44 events/PYE, respectively). The rates of nocturnal-confirmed hypoglycaemia were lower for IDeg than for IGlar (0.18 vs. 0.28 events/PYE, respectively). No severe episode occurred in either treatment group. In both studies, IDeg was well tolerated with no difference in safety between the two analogues investigated.Conclusions. In both T1D and T2D, IDeg provided similar glycaemic control to IGlar, with a lower risk of nocturnal hypoglycaemia.https://www.dia-endojournals.ru/jour/article/view/7694diabetes mellitusglycaemic controlinsulin analoguesinsulin therapythe phase 3 study |
| spellingShingle | Marina Vladimirovna Shestakova Michail Vladimirovich Antciferov Alexander Yur'evich Mayorov Luydmila Alexandrovna Ruyatkina Ludmila Alexandrovna Suplotova Sergey Anatol'evich Dogadin Nikolay Borisovich Lebedev Yana Gennadievna Alekseeva Insulin degludec: a new basal insulin analogue with an ultra-long duration of action. Safety and efficacy in Russian patients with diabetes Сахарный диабет diabetes mellitus glycaemic control insulin analogues insulin therapy the phase 3 study |
| title | Insulin degludec: a new basal insulin analogue with an ultra-long duration of action. Safety and efficacy in Russian patients with diabetes |
| title_full | Insulin degludec: a new basal insulin analogue with an ultra-long duration of action. Safety and efficacy in Russian patients with diabetes |
| title_fullStr | Insulin degludec: a new basal insulin analogue with an ultra-long duration of action. Safety and efficacy in Russian patients with diabetes |
| title_full_unstemmed | Insulin degludec: a new basal insulin analogue with an ultra-long duration of action. Safety and efficacy in Russian patients with diabetes |
| title_short | Insulin degludec: a new basal insulin analogue with an ultra-long duration of action. Safety and efficacy in Russian patients with diabetes |
| title_sort | insulin degludec a new basal insulin analogue with an ultra long duration of action safety and efficacy in russian patients with diabetes |
| topic | diabetes mellitus glycaemic control insulin analogues insulin therapy the phase 3 study |
| url | https://www.dia-endojournals.ru/jour/article/view/7694 |
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