Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN® Basal-Bolus Type 1): 2-year results of a randomized clinical trial
Aims The goal of this study was to compare the long‐term safety and efficacy of the basal insulin analogue, insulin degludec with insulin glargine (both with insulin aspart) in Type 1 diabetes, over a 2‐year time period. Methods This open‐label trial comprised a 1‐year main trial and a 1‐year extens...
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| Veröffentlicht in: | Diabetic medicine 2013-11, Vol.30 (11), p.1293-1297 |
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| creator | Bode, B. W. Buse, J. B. Fisher, M. Garg, S. K. Marre, M. Merker, L. Renard, E. Russell-Jones, D. L. Hansen, C. T. Rana, A. Heller, S. R. |
| description | Aims
The goal of this study was to compare the long‐term safety and efficacy of the basal insulin analogue, insulin degludec with insulin glargine (both with insulin aspart) in Type 1 diabetes, over a 2‐year time period.
Methods
This open‐label trial comprised a 1‐year main trial and a 1‐year extension. Patients were randomized to once‐daily insulin degludec or insulin glargine and titrated to pre‐breakfast plasma glucose values of 3.9–4.9 mmol/l.
Results
The rate of nocturnal confirmed hypoglycaemia was 25% lower with insulin degludec than with insulin glargine (P = 0.02). Rates of confirmed hypoglycaemia, severe hypoglycaemia and adverse events, and reductions in glycated haemoglobin and fasting plasma glucose were similar between groups. Despite achieving similar glycaemic control, insulin degludec‐treated patients used 12% less basal and 9% less total daily insulin than did insulin glargine‐treated patients (P |
| doi_str_mv | 10.1111/dme.12243 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_hal_p</sourceid><recordid>TN_cdi_hal_primary_oai_HAL_hal_01930677v1</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3101537471</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4343-a085d7429f54de48fc01c349e39ab86f36978810fe72175f3ecdcd6134fdc3a23</originalsourceid><addsrcrecordid>eNp1kstuEzEUhgcEEqGw4A0sISS6mHY89tzYNSUkkdKyKZeddeI5k7j1jFPbaRiehifgIfpkOJdmhzeWrO__dHzOiaJ3NDmj4ZzXLZ7RNOXseTSgPOdxxiv6IhokBU9jlhT0VfTaudskoWnFqsGzaNq5tVYdqXGh1zVKotqVNQ_oyEL3ErBVkkjTeWs02Si_JNps0JLOSL-2HWiy7FfmCQVilbsjfgkdUQfxQoNdqA7DA5mDAx3PjV474i2Cb7Hze22LoL1q8ZgDtwLrt6mbfoWPfyipFczRh8o-Dkfj6fXjXzLc-YY734E6_UTSuEewxGIQeUdMQ0Jd0NWmVb-xJjLYlQyVe6tAv4leNqAdvj3cJ9G3L6Oby0k8-zqeXl7MYskZZzEkZVaHHlZNxmvkZSMTKhmvkFUwL_OG5VVRljRpsEhpkTUMZS3rnDLe1JJByk6i0713CVqsrGrB9sKAEpOLmdi-JbRiSV4UDzSw7_dsmMT9Gp0Xt2bXbCco52kYKQvw0Sitcc5ic9TSRGyXQYRlELtlCOyHgxFc-HoT2iGVOwbSogwY3zrP99xGaez_LxSfr0ZP5nifUM7jr2MC7J3IC1Zk4sf1WLAkG7KryU_xnf0Dk0PXqg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1442549319</pqid></control><display><type>article</type><title>Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN® Basal-Bolus Type 1): 2-year results of a randomized clinical trial</title><source>Wiley Online Library Journals Frontfile Complete</source><creator>Bode, B. W. ; Buse, J. B. ; Fisher, M. ; Garg, S. K. ; Marre, M. ; Merker, L. ; Renard, E. ; Russell-Jones, D. L. ; Hansen, C. T. ; Rana, A. ; Heller, S. R.</creator><creatorcontrib>Bode, B. W. ; Buse, J. B. ; Fisher, M. ; Garg, S. K. ; Marre, M. ; Merker, L. ; Renard, E. ; Russell-Jones, D. L. ; Hansen, C. T. ; Rana, A. ; Heller, S. R. ; BEGIN Basal–Bolus Type 1 Trial Investigators</creatorcontrib><description>Aims
The goal of this study was to compare the long‐term safety and efficacy of the basal insulin analogue, insulin degludec with insulin glargine (both with insulin aspart) in Type 1 diabetes, over a 2‐year time period.
Methods
This open‐label trial comprised a 1‐year main trial and a 1‐year extension. Patients were randomized to once‐daily insulin degludec or insulin glargine and titrated to pre‐breakfast plasma glucose values of 3.9–4.9 mmol/l.
Results
The rate of nocturnal confirmed hypoglycaemia was 25% lower with insulin degludec than with insulin glargine (P = 0.02). Rates of confirmed hypoglycaemia, severe hypoglycaemia and adverse events, and reductions in glycated haemoglobin and fasting plasma glucose were similar between groups. Despite achieving similar glycaemic control, insulin degludec‐treated patients used 12% less basal and 9% less total daily insulin than did insulin glargine‐treated patients (P < 0.01).
Conclusions
Long‐term basal therapy using insulin degludec in Type 1 diabetes required lower doses and was associated with a 25% lower risk for nocturnal hypoglycaemia than insulin glargine.
What's new?
Insulin degludec is the first basal insulin analogue with an ultra‐long duration of action for the treatment of Type 1 and Type 2 diabetes mellitus.
The pharmacokinetic and pharmacodynamic profile of insulin degludec results in similar efficacy but reduces the risk of nocturnal hypoglycaemia compared with currently marketed basal insulins.
This multi‐centre, multinational, 2‐year study reaffirms the long‐term safety and efficacy of insulin degludec in patients with Type 1 diabetes in a basal–bolus regimen with insulin aspart.</description><identifier>ISSN: 0742-3071</identifier><identifier>EISSN: 1464-5491</identifier><identifier>DOI: 10.1111/dme.12243</identifier><identifier>CODEN: DIMEEV</identifier><language>eng</language><publisher>Oxford: Blackwell Publishing Ltd</publisher><subject>Biological and medical sciences ; Diabetes ; Diabetes. Impaired glucose tolerance ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Feeding. Feeding behavior ; Fundamental and applied biological sciences. Psychology ; Human health and pathology ; Life Sciences ; Medical sciences ; Vertebrates: anatomy and physiology, studies on body, several organs or systems ; Vertebrates: endocrinology</subject><ispartof>Diabetic medicine, 2013-11, Vol.30 (11), p.1293-1297</ispartof><rights>2013 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.</rights><rights>2014 INIST-CNRS</rights><rights>Diabetic Medicine © 2013 Diabetes UK</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4343-a085d7429f54de48fc01c349e39ab86f36978810fe72175f3ecdcd6134fdc3a23</citedby><cites>FETCH-LOGICAL-c4343-a085d7429f54de48fc01c349e39ab86f36978810fe72175f3ecdcd6134fdc3a23</cites><orcidid>0000-0003-4378-0468</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdme.12243$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdme.12243$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27822449$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.univ-grenoble-alpes.fr/hal-01930677$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Bode, B. W.</creatorcontrib><creatorcontrib>Buse, J. B.</creatorcontrib><creatorcontrib>Fisher, M.</creatorcontrib><creatorcontrib>Garg, S. K.</creatorcontrib><creatorcontrib>Marre, M.</creatorcontrib><creatorcontrib>Merker, L.</creatorcontrib><creatorcontrib>Renard, E.</creatorcontrib><creatorcontrib>Russell-Jones, D. L.</creatorcontrib><creatorcontrib>Hansen, C. T.</creatorcontrib><creatorcontrib>Rana, A.</creatorcontrib><creatorcontrib>Heller, S. R.</creatorcontrib><creatorcontrib>BEGIN Basal–Bolus Type 1 Trial Investigators</creatorcontrib><title>Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN® Basal-Bolus Type 1): 2-year results of a randomized clinical trial</title><title>Diabetic medicine</title><addtitle>Diabet. Med</addtitle><description>Aims
The goal of this study was to compare the long‐term safety and efficacy of the basal insulin analogue, insulin degludec with insulin glargine (both with insulin aspart) in Type 1 diabetes, over a 2‐year time period.
Methods
This open‐label trial comprised a 1‐year main trial and a 1‐year extension. Patients were randomized to once‐daily insulin degludec or insulin glargine and titrated to pre‐breakfast plasma glucose values of 3.9–4.9 mmol/l.
Results
The rate of nocturnal confirmed hypoglycaemia was 25% lower with insulin degludec than with insulin glargine (P = 0.02). Rates of confirmed hypoglycaemia, severe hypoglycaemia and adverse events, and reductions in glycated haemoglobin and fasting plasma glucose were similar between groups. Despite achieving similar glycaemic control, insulin degludec‐treated patients used 12% less basal and 9% less total daily insulin than did insulin glargine‐treated patients (P < 0.01).
Conclusions
Long‐term basal therapy using insulin degludec in Type 1 diabetes required lower doses and was associated with a 25% lower risk for nocturnal hypoglycaemia than insulin glargine.
What's new?
Insulin degludec is the first basal insulin analogue with an ultra‐long duration of action for the treatment of Type 1 and Type 2 diabetes mellitus.
The pharmacokinetic and pharmacodynamic profile of insulin degludec results in similar efficacy but reduces the risk of nocturnal hypoglycaemia compared with currently marketed basal insulins.
This multi‐centre, multinational, 2‐year study reaffirms the long‐term safety and efficacy of insulin degludec in patients with Type 1 diabetes in a basal–bolus regimen with insulin aspart.</description><subject>Biological and medical sciences</subject><subject>Diabetes</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Etiopathogenesis. Screening. Investigations. Target tissue resistance</subject><subject>Feeding. Feeding behavior</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Human health and pathology</subject><subject>Life Sciences</subject><subject>Medical sciences</subject><subject>Vertebrates: anatomy and physiology, studies on body, several organs or systems</subject><subject>Vertebrates: endocrinology</subject><issn>0742-3071</issn><issn>1464-5491</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><recordid>eNp1kstuEzEUhgcEEqGw4A0sISS6mHY89tzYNSUkkdKyKZeddeI5k7j1jFPbaRiehifgIfpkOJdmhzeWrO__dHzOiaJ3NDmj4ZzXLZ7RNOXseTSgPOdxxiv6IhokBU9jlhT0VfTaudskoWnFqsGzaNq5tVYdqXGh1zVKotqVNQ_oyEL3ErBVkkjTeWs02Si_JNps0JLOSL-2HWiy7FfmCQVilbsjfgkdUQfxQoNdqA7DA5mDAx3PjV474i2Cb7Hze22LoL1q8ZgDtwLrt6mbfoWPfyipFczRh8o-Dkfj6fXjXzLc-YY734E6_UTSuEewxGIQeUdMQ0Jd0NWmVb-xJjLYlQyVe6tAv4leNqAdvj3cJ9G3L6Oby0k8-zqeXl7MYskZZzEkZVaHHlZNxmvkZSMTKhmvkFUwL_OG5VVRljRpsEhpkTUMZS3rnDLe1JJByk6i0713CVqsrGrB9sKAEpOLmdi-JbRiSV4UDzSw7_dsmMT9Gp0Xt2bXbCco52kYKQvw0Sitcc5ic9TSRGyXQYRlELtlCOyHgxFc-HoT2iGVOwbSogwY3zrP99xGaez_LxSfr0ZP5nifUM7jr2MC7J3IC1Zk4sf1WLAkG7KryU_xnf0Dk0PXqg</recordid><startdate>201311</startdate><enddate>201311</enddate><creator>Bode, B. W.</creator><creator>Buse, J. B.</creator><creator>Fisher, M.</creator><creator>Garg, S. K.</creator><creator>Marre, M.</creator><creator>Merker, L.</creator><creator>Renard, E.</creator><creator>Russell-Jones, D. L.</creator><creator>Hansen, C. T.</creator><creator>Rana, A.</creator><creator>Heller, S. R.</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><general>Wiley Subscription Services, Inc</general><general>Wiley</general><scope>BSCLL</scope><scope>24P</scope><scope>IQODW</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>P64</scope><scope>RC3</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0003-4378-0468</orcidid></search><sort><creationdate>201311</creationdate><title>Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN® Basal-Bolus Type 1): 2-year results of a randomized clinical trial</title><author>Bode, B. W. ; Buse, J. B. ; Fisher, M. ; Garg, S. K. ; Marre, M. ; Merker, L. ; Renard, E. ; Russell-Jones, D. L. ; Hansen, C. T. ; Rana, A. ; Heller, S. R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4343-a085d7429f54de48fc01c349e39ab86f36978810fe72175f3ecdcd6134fdc3a23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Biological and medical sciences</topic><topic>Diabetes</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Etiopathogenesis. Screening. Investigations. Target tissue resistance</topic><topic>Feeding. Feeding behavior</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Human health and pathology</topic><topic>Life Sciences</topic><topic>Medical sciences</topic><topic>Vertebrates: anatomy and physiology, studies on body, several organs or systems</topic><topic>Vertebrates: endocrinology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bode, B. W.</creatorcontrib><creatorcontrib>Buse, J. B.</creatorcontrib><creatorcontrib>Fisher, M.</creatorcontrib><creatorcontrib>Garg, S. K.</creatorcontrib><creatorcontrib>Marre, M.</creatorcontrib><creatorcontrib>Merker, L.</creatorcontrib><creatorcontrib>Renard, E.</creatorcontrib><creatorcontrib>Russell-Jones, D. L.</creatorcontrib><creatorcontrib>Hansen, C. T.</creatorcontrib><creatorcontrib>Rana, A.</creatorcontrib><creatorcontrib>Heller, S. R.</creatorcontrib><creatorcontrib>BEGIN Basal–Bolus Type 1 Trial Investigators</creatorcontrib><collection>Istex</collection><collection>Wiley Online Library Open Access</collection><collection>Pascal-Francis</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Diabetic medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bode, B. W.</au><au>Buse, J. B.</au><au>Fisher, M.</au><au>Garg, S. K.</au><au>Marre, M.</au><au>Merker, L.</au><au>Renard, E.</au><au>Russell-Jones, D. L.</au><au>Hansen, C. T.</au><au>Rana, A.</au><au>Heller, S. R.</au><aucorp>BEGIN Basal–Bolus Type 1 Trial Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN® Basal-Bolus Type 1): 2-year results of a randomized clinical trial</atitle><jtitle>Diabetic medicine</jtitle><addtitle>Diabet. Med</addtitle><date>2013-11</date><risdate>2013</risdate><volume>30</volume><issue>11</issue><spage>1293</spage><epage>1297</epage><pages>1293-1297</pages><issn>0742-3071</issn><eissn>1464-5491</eissn><coden>DIMEEV</coden><abstract>Aims
The goal of this study was to compare the long‐term safety and efficacy of the basal insulin analogue, insulin degludec with insulin glargine (both with insulin aspart) in Type 1 diabetes, over a 2‐year time period.
Methods
This open‐label trial comprised a 1‐year main trial and a 1‐year extension. Patients were randomized to once‐daily insulin degludec or insulin glargine and titrated to pre‐breakfast plasma glucose values of 3.9–4.9 mmol/l.
Results
The rate of nocturnal confirmed hypoglycaemia was 25% lower with insulin degludec than with insulin glargine (P = 0.02). Rates of confirmed hypoglycaemia, severe hypoglycaemia and adverse events, and reductions in glycated haemoglobin and fasting plasma glucose were similar between groups. Despite achieving similar glycaemic control, insulin degludec‐treated patients used 12% less basal and 9% less total daily insulin than did insulin glargine‐treated patients (P < 0.01).
Conclusions
Long‐term basal therapy using insulin degludec in Type 1 diabetes required lower doses and was associated with a 25% lower risk for nocturnal hypoglycaemia than insulin glargine.
What's new?
Insulin degludec is the first basal insulin analogue with an ultra‐long duration of action for the treatment of Type 1 and Type 2 diabetes mellitus.
The pharmacokinetic and pharmacodynamic profile of insulin degludec results in similar efficacy but reduces the risk of nocturnal hypoglycaemia compared with currently marketed basal insulins.
This multi‐centre, multinational, 2‐year study reaffirms the long‐term safety and efficacy of insulin degludec in patients with Type 1 diabetes in a basal–bolus regimen with insulin aspart.</abstract><cop>Oxford</cop><pub>Blackwell Publishing Ltd</pub><doi>10.1111/dme.12243</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0003-4378-0468</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Diabetic medicine, 2013-11, Vol.30 (11), p.1293-1297 |
| issn | 0742-3071 1464-5491 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_01930677v1 |
| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Biological and medical sciences Diabetes Diabetes. Impaired glucose tolerance Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance Feeding. Feeding behavior Fundamental and applied biological sciences. Psychology Human health and pathology Life Sciences Medical sciences Vertebrates: anatomy and physiology, studies on body, several organs or systems Vertebrates: endocrinology |
| title | Insulin degludec improves glycaemic control with lower nocturnal hypoglycaemia risk than insulin glargine in basal-bolus treatment with mealtime insulin aspart in Type 1 diabetes (BEGIN® Basal-Bolus Type 1): 2-year results of a randomized clinical trial |
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