RU2011109016A - Применение сверхбыстродействующего инсулина - Google Patents
Применение сверхбыстродействующего инсулина Download PDFInfo
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- RU2011109016A RU2011109016A RU2011109016/15A RU2011109016A RU2011109016A RU 2011109016 A RU2011109016 A RU 2011109016A RU 2011109016/15 A RU2011109016/15 A RU 2011109016/15A RU 2011109016 A RU2011109016 A RU 2011109016A RU 2011109016 A RU2011109016 A RU 2011109016A
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- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 title claims abstract 64
- 102000004877 Insulin Human genes 0.000 title claims abstract 30
- 108090001061 Insulin Proteins 0.000 title claims abstract 30
- 229940125396 insulin Drugs 0.000 title claims abstract 30
- 238000000034 method Methods 0.000 claims abstract 28
- 235000012054 meals Nutrition 0.000 claims abstract 18
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims abstract 14
- 230000009229 glucose formation Effects 0.000 claims abstract 9
- 210000004185 liver Anatomy 0.000 claims abstract 9
- 235000013305 food Nutrition 0.000 claims abstract 7
- 238000011282 treatment Methods 0.000 claims abstract 7
- 108010092217 Long-Acting Insulin Chemical class 0.000 claims abstract 6
- 102000016261 Long-Acting Insulin Human genes 0.000 claims abstract 6
- 229940100066 Long-acting insulin Drugs 0.000 claims abstract 6
- 239000003623 enhancer Substances 0.000 claims abstract 6
- 230000003914 insulin secretion Effects 0.000 claims abstract 6
- 235000021316 daily nutritional intake Nutrition 0.000 claims abstract 5
- 239000000203 mixture Substances 0.000 claims abstract 5
- 108010057186 Insulin Glargine Proteins 0.000 claims abstract 4
- COCFEDIXXNGUNL-RFKWWTKHSA-N Insulin glargine Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@H]1CSSC[C@H]2C(=O)N[C@H](C(=O)N[C@@H](CO)C(=O)N[C@H](C(=O)N[C@H](C(N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=3C=CC(O)=CC=3)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3C=CC(O)=CC=3)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=3NC=NC=3)NC(=O)[C@H](CO)NC(=O)CNC1=O)C(=O)NCC(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(=O)NCC(O)=O)=O)CSSC[C@@H](C(N2)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C(C)C)NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)[C@@H](C)CC)[C@@H](C)O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)CC=1C=CC=CC=1)C(C)C)C1=CN=CN1 COCFEDIXXNGUNL-RFKWWTKHSA-N 0.000 claims abstract 4
- 239000004026 insulin derivative Substances 0.000 claims abstract 4
- 229960002869 insulin glargine Drugs 0.000 claims abstract 4
- 230000002641 glycemic effect Effects 0.000 claims abstract 3
- 201000001421 hyperglycemia Diseases 0.000 claims abstract 3
- 238000011284 combination treatment Methods 0.000 claims abstract 2
- 230000002618 waking effect Effects 0.000 claims abstract 2
- 230000002354 daily effect Effects 0.000 claims 7
- 238000004448 titration Methods 0.000 claims 5
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 4
- 206010022489 Insulin Resistance Diseases 0.000 claims 4
- 239000008103 glucose Substances 0.000 claims 4
- 239000008280 blood Substances 0.000 claims 3
- 210000004369 blood Anatomy 0.000 claims 3
- 238000007920 subcutaneous administration Methods 0.000 claims 3
- BBNKIRVUCQNAQR-FETIZUMASA-N (e)-4-[4-[(2s,5s)-5-[4-[[(e)-3-carboxyprop-2-enoyl]amino]butyl]-3,6-dioxopiperazin-2-yl]butylamino]-4-oxobut-2-enoic acid Chemical compound OC(=O)\C=C\C(=O)NCCCC[C@@H]1NC(=O)[C@H](CCCCNC(=O)\C=C\C(O)=O)NC1=O BBNKIRVUCQNAQR-FETIZUMASA-N 0.000 claims 2
- 238000010521 absorption reaction Methods 0.000 claims 2
- 230000003111 delayed effect Effects 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 2
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- 229940094417 fumaryl diketopiperazine Drugs 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- 235000015097 nutrients Nutrition 0.000 claims 2
- 230000000291 postprandial effect Effects 0.000 claims 2
- 208000013016 Hypoglycemia Diseases 0.000 claims 1
- 229940122355 Insulin sensitizer Drugs 0.000 claims 1
- 108010026951 Short-Acting Insulin Proteins 0.000 claims 1
- 229940123958 Short-acting insulin Drugs 0.000 claims 1
- 230000003203 everyday effect Effects 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 230000000977 initiatory effect Effects 0.000 claims 1
- 210000004072 lung Anatomy 0.000 claims 1
- 230000002035 prolonged effect Effects 0.000 claims 1
- 230000004584 weight gain Effects 0.000 claims 1
- 235000019786 weight gain Nutrition 0.000 claims 1
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/28—Insulins
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
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Abstract
1. Способ контроля гликемии, связанной с каждодневным приемом пищи, без коррекции дозы инсулина по содержимому пищи, включающий стадию введения предварительно определенной дозировки сверхбыстродействующего состава инсулина во время приема пищи для каждого каждодневного приема пищи. ! 2. Способ по п.1, где содержимое пищи составляет от ≥25% до ≤200% от обычного содержимого пищи, как используют при определении предварительно определенной дозы. ! 3. Способ лечения диабета 2 типа, включающий: выбор пациента с диабетом 2 типа, которого в текущий момент лечат супрессором продукции глюкозы печенью, который в настоящее время нуждается в улучшенном гликемическом контроле и который является кандидатом для комбинированного лечения указанным супрессором продукции глюкозы печенью и усилителем секреции инсулина; и вместо этого комбинированное лечение указанным супрессором продукции глюкозы печенью с регулярным введением сверхбыстродействующего препарата инсулина по меньшей мере с одним устоявшимся приемом пищи. ! 4. Улучшенный способ лечения гипергликемии комбинацией сверхбыстродействующего инсулина и аналога инсулина длительного действия, включающий: прандиальное введение сверхбыстродействующего инсулина, и введение дозы аналога инсулина длительного действия в пределах 6 часов после пробуждения на сутки. ! 5. Способ по п.4, где инсулин длительного действия представляет собой инсулин гларгин, и способ дополнительно включает введение второй дозы инсулина гларгин и вторую дозу вводят от 8 до 14 ч после указанной утренней дозы. ! 6. Способ лечения диабета 2 типа, включающий: выбор пациента с диабетом 2 типа, в текущее врем
Claims (18)
1. Способ контроля гликемии, связанной с каждодневным приемом пищи, без коррекции дозы инсулина по содержимому пищи, включающий стадию введения предварительно определенной дозировки сверхбыстродействующего состава инсулина во время приема пищи для каждого каждодневного приема пищи.
2. Способ по п.1, где содержимое пищи составляет от ≥25% до ≤200% от обычного содержимого пищи, как используют при определении предварительно определенной дозы.
3. Способ лечения диабета 2 типа, включающий: выбор пациента с диабетом 2 типа, которого в текущий момент лечат супрессором продукции глюкозы печенью, который в настоящее время нуждается в улучшенном гликемическом контроле и который является кандидатом для комбинированного лечения указанным супрессором продукции глюкозы печенью и усилителем секреции инсулина; и вместо этого комбинированное лечение указанным супрессором продукции глюкозы печенью с регулярным введением сверхбыстродействующего препарата инсулина по меньшей мере с одним устоявшимся приемом пищи.
4. Улучшенный способ лечения гипергликемии комбинацией сверхбыстродействующего инсулина и аналога инсулина длительного действия, включающий: прандиальное введение сверхбыстродействующего инсулина, и введение дозы аналога инсулина длительного действия в пределах 6 часов после пробуждения на сутки.
5. Способ по п.4, где инсулин длительного действия представляет собой инсулин гларгин, и способ дополнительно включает введение второй дозы инсулина гларгин и вторую дозу вводят от 8 до 14 ч после указанной утренней дозы.
6. Способ лечения диабета 2 типа, включающий: выбор пациента с диабетом 2 типа, в текущее время подвергаемого лечению супрессором продукции глюкозы печенью и усилителем секреции инсулина; прекращение лечения усилителем секреции инсулина; и регулярное введение сверхбыстродействующего препарата инсулина по меньшей мере с одним устоявшимся приемом пищи.
7. Способ по п.6, где лечение супрессором продукции глюкозы печенью также прекращают.
8. Способ по п.7, где пациента, кроме того, выбирают по наличию резистентности к инсулину в нижней части диапазона резистентности к инсулину, по имеющейся необходимости в снижении или избегании увеличения массы тела, по наличию боязни укола иглой или желанию избежать частых инъекций, по наличию хорошо или умеренно контролируемого уровня глюкозы в крови натощак, по наличию уровня HbA1c ≥8, или по наличию повышенной средней амплитуды колебаний концентрации глюкозы.
9. Способ по п.6, где указанный сверхбыстродействующий препарат инсулина вводят в дозировке, достаточной для максимального снижения продукции глюкозы печенью в пределах 60 мин после введения.
10. Способ по п.6, где указанный сверхбыстродействующий препарат инсулина вводят в дозировке, которая находится в диапазоне от 1 до 32 подкожных эквивалентных единиц.
11. Способ по любому из пп.1, 3, 4 или 6, где сверхбыстродействующий инсулин вводят путем ингаляции в легкие.
12. Способ по любому из пп.1, 3, 4 или 6, где сверхбыстродействующий инсулин представляет собой инсулин, связанный с фумарилдикетопиперазином (FDKP).
13. Способ по любому из пп.1, 3 или 4, где индивидуальную дозировку сверхбыстродействующего инсулина для каждодневного приема пищи определяют способом, включающим стадии: введения низкой дозы сверхбыстродействующего инсулина во время приема пищи при каждодневном приеме пищи, для которого дозировку титровали каждые сутки в течение по меньшей мере 3 суток в течение периода титрования, составляющего не более недели; многократного повышения дозировки на величину низкой дозы в каждый последующий период титрования и введения во время приема пищи при каждодневном приеме пищи, для каждого из которых проводили титрование дозировки, в течение по меньшей мере трех суток в период титрования до достижения конечного результата титрования.
14. Способ контроля гликемии, связанной с каждодневным приемом пищи, где дозировку инсулина корректируют по гликемической нагрузке употребленной пищи, включающий стадии: введения начальной предварительно определенной дозы сверхбыстродействующего состава инсулина во время приема пищи при каждодневном приеме пищи; определения постпрандиального уровня глюкозы в крови через от 1 до 2 ч после начала каждодневного приема пищи; и, если постпрандиальный уровень глюкозы в крови составляет >140 мг/дл, введение второй дозы сверхбыстродействующего инсулина, где вторая доза составляет от 25% до 100% от начальной дозы.
15. Способ контроля гликемии, связанной с каждодневным приемом пищи, у пациента с замедленным или пролонгированным всасыванием питательных веществ, включающий стадии: выбора пациента с замедленным всасыванием питательных веществ; введения от 50% до 75% предварительно определенной дозировки сверхбыстродействующего состава инсулина во время приема пищи при каждодневном приеме пищи; и введения оставшейся части предварительно определенной дозировки от 30 до 120 мин после начала каждодневного приема пищи.
16. Улучшенный способ лечения гипергликемии комбинацией сверхбыстродействующего инсулина и экзогенного базального инсулина, включающий: прандиальное введение сверхбыстродействующего инсулина и непрерывную инфузию инсулина короткого действия с помощью инсулинового насоса.
17. Способ лечения диабета 2 типа, включающий: выбор пациента с диабетом 2 типа, в текущее время подвергаемого лечению сенсибилизатором к инсулину и усилителем секреции инсулина; прекращение лечения усилителем секреции инсулина; и регулярное введение сверхбыстродействующего препарата инсулина с каждым приемом пищи.
18. Способ лечения диабетиков с резистентностью к подкожному инсулину, включающий стадии: выбора пациента с резистентностью к подкожному инсулину, исходя из нетипично высокой дозировки инсулина; прекращение лечения подкожно вводимыми составами инсулина быстрого, короткого или среднего действия; и начало лечения путем введения прандиальных доз инсулин-FDKP путем ингаляции, эффективных для контроля постпрандиальной гипогликемии.
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