Cargando…
Twice‐daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin‐naïve adults with Type 2 diabetes
AIM: To evaluate the efficacy and safety of twice‐daily insulin degludec/insulin aspart vs. twice‐daily biphasic insulin aspart 30 in people with Type 2 diabetes mellitus who were naïve to insulin. METHODS: In this 26‐week, multinational, open‐label, controlled, two‐arm, parallel‐group, treat‐to‐tar...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2015
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5063147/ https://www.ncbi.nlm.nih.gov/pubmed/26435365 http://dx.doi.org/10.1111/dme.12982 |
_version_ | 1782459916688031744 |
---|---|
author | Franek, E. Haluzík, M. Canecki Varžić, S. Sargin, M. Macura, S. Zacho, J. Christiansen, J. S. |
author_facet | Franek, E. Haluzík, M. Canecki Varžić, S. Sargin, M. Macura, S. Zacho, J. Christiansen, J. S. |
author_sort | Franek, E. |
collection | PubMed |
description | AIM: To evaluate the efficacy and safety of twice‐daily insulin degludec/insulin aspart vs. twice‐daily biphasic insulin aspart 30 in people with Type 2 diabetes mellitus who were naïve to insulin. METHODS: In this 26‐week, multinational, open‐label, controlled, two‐arm, parallel‐group, treat‐to‐target trial, participants [mean (± sd) age 58.9 (±8.9) years, duration of diabetes 9.5 (±5.9) years, HbA(1c) 68 (±8.7) mmol/mol or 8.4 (±0.8)% and BMI 31.2 (±4.2) kg/m(2)) were randomized (1:1) to insulin degludec/insulin aspart (n = 197) or biphasic insulin aspart 30 (n = 197), administered with breakfast and the main evening meal, titrated to a self‐monitored plasma glucose target > 3.9 and ≤ 5.0 mmol/l. RESULTS: The mean HbA(1c) was reduced to 49 mmol/mol (6.6%) with insulin degludec/insulin aspart and 48 mmol/mol (6.5%) with biphasic insulin aspart 30. Insulin degludec/insulin aspart achieved the prespecified non‐inferiority margin (estimated treatment difference 0.02%; 95% CI −0.12, 0.17). Insulin degludec/insulin aspart was superior in lowering fasting plasma glucose (estimated treatment difference −1.00 mmol/l; 95% CI −1.4, −0.6; P < 0.001) and reducing overall and nocturnal confirmed hypoglycaemia at a similar overall insulin dose compared with biphasic insulin aspart 30. Similar proportions of participants in each arm experienced severe hypoglycaemia. Adverse events were equally distributed. CONCLUSIONS: Consistent with previous findings, insulin degludec/insulin aspart twice daily effectively improved long‐term glycaemic control, with superior reductions in FPG, and significantly less overall and nocturnal confirmed hypoglycaemia compared with biphasic insulin aspart 30 in people with Type 2 diabetes who were insulin‐naïve. |
format | Online Article Text |
id | pubmed-5063147 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-50631472016-10-19 Twice‐daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin‐naïve adults with Type 2 diabetes Franek, E. Haluzík, M. Canecki Varžić, S. Sargin, M. Macura, S. Zacho, J. Christiansen, J. S. Diabet Med Research Articles AIM: To evaluate the efficacy and safety of twice‐daily insulin degludec/insulin aspart vs. twice‐daily biphasic insulin aspart 30 in people with Type 2 diabetes mellitus who were naïve to insulin. METHODS: In this 26‐week, multinational, open‐label, controlled, two‐arm, parallel‐group, treat‐to‐target trial, participants [mean (± sd) age 58.9 (±8.9) years, duration of diabetes 9.5 (±5.9) years, HbA(1c) 68 (±8.7) mmol/mol or 8.4 (±0.8)% and BMI 31.2 (±4.2) kg/m(2)) were randomized (1:1) to insulin degludec/insulin aspart (n = 197) or biphasic insulin aspart 30 (n = 197), administered with breakfast and the main evening meal, titrated to a self‐monitored plasma glucose target > 3.9 and ≤ 5.0 mmol/l. RESULTS: The mean HbA(1c) was reduced to 49 mmol/mol (6.6%) with insulin degludec/insulin aspart and 48 mmol/mol (6.5%) with biphasic insulin aspart 30. Insulin degludec/insulin aspart achieved the prespecified non‐inferiority margin (estimated treatment difference 0.02%; 95% CI −0.12, 0.17). Insulin degludec/insulin aspart was superior in lowering fasting plasma glucose (estimated treatment difference −1.00 mmol/l; 95% CI −1.4, −0.6; P < 0.001) and reducing overall and nocturnal confirmed hypoglycaemia at a similar overall insulin dose compared with biphasic insulin aspart 30. Similar proportions of participants in each arm experienced severe hypoglycaemia. Adverse events were equally distributed. CONCLUSIONS: Consistent with previous findings, insulin degludec/insulin aspart twice daily effectively improved long‐term glycaemic control, with superior reductions in FPG, and significantly less overall and nocturnal confirmed hypoglycaemia compared with biphasic insulin aspart 30 in people with Type 2 diabetes who were insulin‐naïve. John Wiley and Sons Inc. 2015-11-17 2016-04 /pmc/articles/PMC5063147/ /pubmed/26435365 http://dx.doi.org/10.1111/dme.12982 Text en © 2015 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Research Articles Franek, E. Haluzík, M. Canecki Varžić, S. Sargin, M. Macura, S. Zacho, J. Christiansen, J. S. Twice‐daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin‐naïve adults with Type 2 diabetes |
title | Twice‐daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin‐naïve adults with Type 2 diabetes |
title_full | Twice‐daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin‐naïve adults with Type 2 diabetes |
title_fullStr | Twice‐daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin‐naïve adults with Type 2 diabetes |
title_full_unstemmed | Twice‐daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin‐naïve adults with Type 2 diabetes |
title_short | Twice‐daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin‐naïve adults with Type 2 diabetes |
title_sort | twice‐daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin‐naïve adults with type 2 diabetes |
topic | Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5063147/ https://www.ncbi.nlm.nih.gov/pubmed/26435365 http://dx.doi.org/10.1111/dme.12982 |
work_keys_str_mv | AT franeke twicedailyinsulindegludecinsulinaspartprovidessuperiorfastingplasmaglucosecontrolandareducedrateofhypoglycaemiacomparedwithbiphasicinsulinaspart30ininsulinnaiveadultswithtype2diabetes AT haluzikm twicedailyinsulindegludecinsulinaspartprovidessuperiorfastingplasmaglucosecontrolandareducedrateofhypoglycaemiacomparedwithbiphasicinsulinaspart30ininsulinnaiveadultswithtype2diabetes AT caneckivarzics twicedailyinsulindegludecinsulinaspartprovidessuperiorfastingplasmaglucosecontrolandareducedrateofhypoglycaemiacomparedwithbiphasicinsulinaspart30ininsulinnaiveadultswithtype2diabetes AT sarginm twicedailyinsulindegludecinsulinaspartprovidessuperiorfastingplasmaglucosecontrolandareducedrateofhypoglycaemiacomparedwithbiphasicinsulinaspart30ininsulinnaiveadultswithtype2diabetes AT macuras twicedailyinsulindegludecinsulinaspartprovidessuperiorfastingplasmaglucosecontrolandareducedrateofhypoglycaemiacomparedwithbiphasicinsulinaspart30ininsulinnaiveadultswithtype2diabetes AT zachoj twicedailyinsulindegludecinsulinaspartprovidessuperiorfastingplasmaglucosecontrolandareducedrateofhypoglycaemiacomparedwithbiphasicinsulinaspart30ininsulinnaiveadultswithtype2diabetes AT christiansenjs twicedailyinsulindegludecinsulinaspartprovidessuperiorfastingplasmaglucosecontrolandareducedrateofhypoglycaemiacomparedwithbiphasicinsulinaspart30ininsulinnaiveadultswithtype2diabetes |