{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T03:47:25Z","timestamp":1773287245940,"version":"3.50.1"},"reference-count":30,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2017,7,6]],"date-time":"2017-07-06T00:00:00Z","timestamp":1499299200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Novo Nordisk A\/S"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2017,10]]},"abstract":"\n Aim<\/jats:title>\n \n To confirm glycaemic control superiority of mealtime fast\u2010acting insulin aspart (faster aspart) in a basal\u2013bolus (\n BB<\/jats:styled-content>\n ) regimen vs basal\u2010only insulin.\n <\/jats:p>\n <\/jats:sec>\n \n Materials and methods<\/jats:title>\n \n In this open\u2010label, randomized, 18\u2010week trial (51 sites; 6 countries), adults (n\u2009=\u2009236) with inadequately controlled type 2 diabetes (\n T2D<\/jats:styled-content>\n ; mean glycosylated haemoglobin [\n HbA1c<\/jats:styled-content>\n ]\u2009\u00b1\u2009\n SD<\/jats:styled-content>\n : 7.9%\u2009\u00b1\u20090.7% [63.1\u2009\u00b1\u20097.5\u2009mmol\/mol]) receiving basal insulin and oral antidiabetic drugs underwent 8\u2010week optimization of prior once\u2010daily basal insulin followed by randomization 1:1 to either a\n BB<\/jats:styled-content>\n regimen with faster aspart (n\u2009=\u2009116) or continuation of once\u2010daily basal insulin (n\u2009=\u2009120), both with metformin. Primary endpoint was\n HbA1c<\/jats:styled-content>\n change from baseline after 18\u2009weeks of treatment. Secondary endpoints included: postprandial plasma glucose (\n PPG<\/jats:styled-content>\n ) change and overall\n PPG<\/jats:styled-content>\n increment (all meals); weight; treatment\u2010emergent adverse events; hypoglycaemic episodes.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n HbA1c<\/jats:styled-content>\n decreased from 7.9% (63.2\u2009mmol\/mol) to 6.8% (50.7\u2009mmol\/mol;\n BB<\/jats:styled-content>\n group) and from 7.9% (63.2\u2009mmol\/mol) to 7.7% (60.7\u2009mmol\/mol; basal\u2010only group); estimated treatment difference [95% confidence interval] \u22120.94% [\u22121.17; \u22120.72]; \u221210.3\u2009mmol\/mol [\u221212.8; \u22127.8];\n \n P<\/jats:italic>\n <\/jats:styled-content>\n \u2009<\u2009.0001. Reductions from baseline in overall mean 2\u2010hour\n PPG<\/jats:styled-content>\n and overall\n PPG<\/jats:styled-content>\n increment for all meals (self\u2010measured plasma glucose profiles) were statistically significant in favour of\n BB<\/jats:styled-content>\n treatment (\n \n P<\/jats:italic>\n <\/jats:styled-content>\n \u2009<\u2009.0001). Severe\/blood glucose confirmed hypoglycaemia rate (12.8 vs 2.0 episodes per patient\u2010years of exposure), total daily insulin (1.2 vs 0.6 U\/kg) and weight gain (1.8 vs 0.2\u2009kg) were greater with\n BB<\/jats:styled-content>\n than with basal\u2010only treatment.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n In\n T2D<\/jats:styled-content>\n , faster aspart in a\n BB<\/jats:styled-content>\n regimen provided superior glycaemic control as compared with basal\u2010only insulin, but with an increase in the frequency of hypoglycaemia and modest weight gain.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.12955","type":"journal-article","created":{"date-parts":[[2017,3,27]],"date-time":"2017-03-27T08:57:16Z","timestamp":1490605036000},"page":"1389-1396","source":"Crossref","is-referenced-by-count":42,"title":["Adding fast\u2010acting insulin aspart to basal insulin significantly improved glycaemic control in patients with type 2 diabetes:\n A<\/scp>\n randomized, 18\u2010week, open\u2010label, phase 3 trial (onset 3)"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6187-8445","authenticated-orcid":false,"given":"Helena W.","family":"Rodbard","sequence":"first","affiliation":[{"name":"Endocrine and Metabolic Consultants Rockville Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Devjit","family":"Tripathy","sequence":"additional","affiliation":[{"name":"University of Texas Health Science Center San Antonio Texas"},{"name":"Audie L Murphy VA Hospital San Antonio Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maricela","family":"Vidrio Vel\u00e1zquez","sequence":"additional","affiliation":[{"name":"Hospital General Regional 110 Guadalajara Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marek","family":"Demissie","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S\u00f8ren C.","family":"Tamer","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Milivoj","family":"Pileti\u010d","sequence":"additional","affiliation":[{"name":"General Hospital Novo Mesto Slovenia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,7,6]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc09-S301"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-2441"},{"issue":"1","key":"e_1_2_6_4_1","first-page":"S4","article-title":"Standards of medical care in diabetes\u20142016: summary of revisions","volume":"39","author":"American Diabetes Association","year":"2016","journal-title":"Diabetes Care"},{"key":"e_1_2_6_5_1","volume-title":"Global Guideline for Type 2 Diabetes","author":"International Diabetes Federation","year":"2012"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.733"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13690-015-0088-6"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.295.14.1681"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.2009.02809.x"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2006.11.011"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.2537"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.2337\/db10-1032"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/dme.12019"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12626"},{"issue":"1","key":"e_1_2_6_15_1","first-page":"A247","article-title":"Clinical outcomes of T2D treatment intensification options vs. no intensification in patients on basal insulin treatment not meeting A1c goals","volume":"65","author":"Levin P","year":"2016","journal-title":"Diabetes"},{"key":"e_1_2_6_16_1","first-page":"A291","article-title":"Mechanistic analysis into the mode of action of niacinamide in faster\u2010acting insulin aspart","author":"Buckley ST","year":"2016","journal-title":"Diabetes Technol Ther"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-017-0514-8"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc16-1771"},{"issue":"1","key":"e_1_2_6_19_1","first-page":"A63","article-title":"Faster\u2010acting insulin aspart vs insulin aspart as part of basal\u2013bolus therapy improves postprandial glycemic control in uncontrolled T2D in the double\u2010blinded onset 2 trial","volume":"65","author":"Bowering K","year":"2016","journal-title":"Diabetes"},{"key":"e_1_2_6_20_1","unstructured":"World Medical Association. 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