{"id":25797,"date":"2012-03-23T11:50:01","date_gmt":"2012-03-23T15:50:01","guid":{"rendered":"http:\/\/asweetlife.org\/?p=25797"},"modified":"2015-12-28T07:36:24","modified_gmt":"2015-12-28T12:36:24","slug":"eu-approves-type-2-diabetes-drug-byetta-for-use-with-basal-insulin","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=25797","title":{"rendered":"EU Approves Type 2 Diabetes Drug Byetta for Use with Basal Insulin"},"content":{"rendered":"
\n

\"\"<\/a>The\u00a0European Commission\u00a0has granted marketing authorization to\u00a0Byetta\u00a0(exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and\/or Actos\u00ae (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.<\/p>\n<\/div>\n

The EU approval was given after\u00a0a clinical trial of patients using fixed-dose\u00a0\u00a0Byetta\u00a0with titrated basal insulin.\u00a0 The patients in the trial achieved better postprandial and overall glycemic control, without weight gain or an increased risk of hypoglycemia, compared to patients using titrated basal insulin without\u00a0\u00a0Byetta\u00a0.<\/p>\n

The study included in the EU marketing authorization submission package was a double-blind, 30-week clinical trial published in\u00a0Annals of Internal Medicine.<\/em>\u00a0In the study,\u00a0\u00a0Byetta\u00a010 micrograms or placebo was added to existing \u00a0insulin glargine (Lantus)\u00a0therapy (with or without metformin, pioglitazone or both), which was titrated to achieve target fasting glucose levels. At study entry, patients who may have been at increased risk of hypoglycemia (A1c less than or equal to 8 percent) reduced their dose of\u00a0 Lantus\u00a0by 20 percent. Five weeks after randomization, all patients had insulin doses titrated to achieve target fasting glucose levels. The primary endpoint was reduction in A1c, a measure of average blood sugar over three months; secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycemia and patient-reported outcomes.<\/p>\n

After 30 weeks of treatment,\u00a0\u00a0Byetta\u00a0demonstrated a statistically significant reduction in A1c compared to placebo, lowering A1c by 1.7 percentage points from a baseline of 8.3 percent. Patients treated with optimized insulin glargine plus placebo experienced a 1.0 percentage point decrease in A1c from a baseline of 8.5 percent. Patients who added\u00a0\u00a0Byetta\u00a0\u00a0to their insulin glargine regimen saw their weight decrease by an average of 4 pounds, compared with an increase of 2 pounds in patients who were treated with optimized insulin glargine plus placebo.\u00a0\u00a0Byetta\u00a0is not indicated for the management of obesity and weight loss was a secondary endpoint in the trial. Change in fasting glucose and hypoglycemia incidence were similar between treatment groups.<\/p>\n

\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"

The European Commission has granted marketing authorization to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and\/or Actos\u00ae (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents…<\/p>\n","protected":false},"author":131,"featured_media":25799,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1443],"tags":[277],"yoast_head":"\nEU Approves Type 2 Diabetes Drug Byetta for Use with Basal Insulin<\/title>\n<meta name=\"description\" content=\"The European Commission has granted marketing authorization to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/asweetlife.org\/?p=25797\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"ASweetLife Team\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/asweetlife.org\/?p=25797\",\"url\":\"https:\/\/asweetlife.org\/?p=25797\",\"name\":\"EU Approves Type 2 Diabetes Drug Byetta for Use with Basal Insulin\",\"isPartOf\":{\"@id\":\"https:\/\/asweetlife.org\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/asweetlife.org\/?p=25797#primaryimage\"},\"image\":{\"@id\":\"https:\/\/asweetlife.org\/?p=25797#primaryimage\"},\"thumbnailUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/Amylin-logo.png\",\"datePublished\":\"2012-03-23T15:50:01+00:00\",\"dateModified\":\"2015-12-28T12:36:24+00:00\",\"author\":{\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585\"},\"description\":\"The European Commission has granted marketing authorization to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin...\",\"breadcrumb\":{\"@id\":\"https:\/\/asweetlife.org\/?p=25797#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/asweetlife.org\/?p=25797\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/?p=25797#primaryimage\",\"url\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/Amylin-logo.png\",\"contentUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/Amylin-logo.png\",\"width\":142,\"height\":63,\"caption\":\"Amylin logo\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/asweetlife.org\/?p=25797#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/asweetlife.org\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"EU Approves Type 2 Diabetes Drug Byetta for Use with Basal Insulin\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/asweetlife.org\/#website\",\"url\":\"https:\/\/asweetlife.org\/\",\"name\":\"ASweetLife\",\"description\":\"The Diabetes Magazine\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/asweetlife.org\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585\",\"name\":\"ASweetLife Team\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g\",\"caption\":\"ASweetLife Team\"},\"url\":\"https:\/\/asweetlife.org\/?author=131\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"EU Approves Type 2 Diabetes Drug Byetta for Use with Basal Insulin","description":"The European Commission has granted marketing authorization to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin...","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/asweetlife.org\/?p=25797","twitter_misc":{"Written by":"ASweetLife Team","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/asweetlife.org\/?p=25797","url":"https:\/\/asweetlife.org\/?p=25797","name":"EU Approves Type 2 Diabetes Drug Byetta for Use with Basal Insulin","isPartOf":{"@id":"https:\/\/asweetlife.org\/#website"},"primaryImageOfPage":{"@id":"https:\/\/asweetlife.org\/?p=25797#primaryimage"},"image":{"@id":"https:\/\/asweetlife.org\/?p=25797#primaryimage"},"thumbnailUrl":"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/Amylin-logo.png","datePublished":"2012-03-23T15:50:01+00:00","dateModified":"2015-12-28T12:36:24+00:00","author":{"@id":"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585"},"description":"The European Commission has granted marketing authorization to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin...","breadcrumb":{"@id":"https:\/\/asweetlife.org\/?p=25797#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/asweetlife.org\/?p=25797"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/asweetlife.org\/?p=25797#primaryimage","url":"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/Amylin-logo.png","contentUrl":"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/Amylin-logo.png","width":142,"height":63,"caption":"Amylin logo"},{"@type":"BreadcrumbList","@id":"https:\/\/asweetlife.org\/?p=25797#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/asweetlife.org\/"},{"@type":"ListItem","position":2,"name":"EU Approves Type 2 Diabetes Drug Byetta for Use with Basal Insulin"}]},{"@type":"WebSite","@id":"https:\/\/asweetlife.org\/#website","url":"https:\/\/asweetlife.org\/","name":"ASweetLife","description":"The Diabetes Magazine","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/asweetlife.org\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585","name":"ASweetLife Team","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/asweetlife.org\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g","caption":"ASweetLife Team"},"url":"https:\/\/asweetlife.org\/?author=131"}]}},"_links":{"self":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts\/25797"}],"collection":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/users\/131"}],"replies":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=25797"}],"version-history":[{"count":0,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts\/25797\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/media\/25799"}],"wp:attachment":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=25797"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=25797"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=25797"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}