{"id":33788,"date":"2013-08-15T05:49:02","date_gmt":"2013-08-15T09:49:02","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&p=33788"},"modified":"2015-12-28T08:12:08","modified_gmt":"2015-12-28T13:12:08","slug":"positive-results-for-mannkinds-inhaled-insulin-afrezza","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=33788","title":{"rendered":"Positive Results for Mannkind’s Inhaled Insulin, Afrezza"},"content":{"rendered":"

\"\"<\/a>MannKind Corporation\u00a0has announced\u00a0that it has positive preliminary results from two Phase 3 clinical studies of\u00a0Afrezza<\/strong>, inhaled\u00a0ultra rapid-acting mealtime insulin.\u00a0<\/p>\n

The first study\u00a0was a double-blind, placebo-controlled study involving 353 patients with\u00a0type 2 diabetes\u00a0<\/strong>whose disease was inadequately controlled on metformin with or without a second or third oral medication. During the 24 week study the patients\u00a0were randomized to one of two groups where, in addition to their oral medication, they received either\u00a0Afrezza\u00a0Inhalation Powder, administered using the Gen2 inhaler or\u00a0Technosphere Inhalation Powder (placebo), administered using the Gen2 inhaler.<\/div>\n
\u00a0<\/div>\n
\n
The primary endpoint of the study was the mean change in A1c levels from baseline to week 24 between the two groups. Over the 24-week treatment period, mean A1c levels decreased by 0.82% in the\u00a0Afrezza\u00a0group compared to a decrease of 0.42% in the comparator oral-therapy group. \u00a0A significantly greater percentage of patients in the\u00a0Afrezza\u00a0group also reached specified A1c target levels than in the comparator oral-therapy group. After 24 weeks of treatment, 37.7% of patients in the\u00a0Afrezza\u00a0group achieved A1c levels below 7.0% compared to only 19.0% of patients in the comparator oral-therapy group, and 15.9% of patients in the\u00a0Afrezza\u00a0group achieved A1c levels below 6.5% compared to only 4.2% of the patients receiving only oral therapy.<\/div>\n
\u00a0<\/div>\n
The second study was\u00a0an open-label study involving 518 type 1 diabetes\u00a0<\/strong>patients on basal\/bolus insulin therapy.\u00a0During the 24-week treatment period in which patients were randomized in one of three groups. The first\u00a0continuing on subcutaneous insulin aspart in combination with a basal insulin, the second continued to use their basal insulin but\u00a0switched to\u00a0Afrezza\u00a0administered using the Gen2 inhaler and the third continued to use their basal insulin while\u00a0switching to\u00a0Afrezza\u00a0administered using the MedTone inhaler in combination with their basal insulin.<\/div>\n
Over the 24-week treatment period of this study, no significant difference was found between the three groups but\u00a0there was a significant difference in fasting blood glucose (FBG) levels in the\u00a0Afrezza\u00a0Gen2 group compared to the insulin aspart group. In the\u00a0Afrezza-Gen2 group, mean FBG levels\u00a0decreased\u00a0by 25.3 mg\/dL by the end of the treatment period whereas the insulin aspart group experienced an\u00a0increase\u00a0of 10.2 mg\/dL in FBG levels over the same period (p=0.0027). After the four-week follow-up period, during which all patients received insulin aspart and a basal insulin, there was no longer any difference in FBG levels between the treatment groups, demonstrating that this effect on FBG levels was attributable to\u00a0Afrezza\u00a0therapy.<\/div>\n
There was also\u00a0significantly less total hypoglycemia in the\u00a0Afrezza-Gen2 group compared to the insulin aspart group.\u00a0<\/div>\n
\u00a0<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

MannKind Corporation has announced that it has positive preliminary results from two Phase 3 clinical studies of Afrezza, inhaled ultra rapid-acting mealtime insulin. <\/p>\n","protected":false},"author":131,"featured_media":33789,"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":[1441],"tags":[670,311],"yoast_head":"\nPositive Results for Mannkind's Inhaled Insulin, Afrezza<\/title>\n<meta name=\"description\" content=\"MannKind Corporation has announced that it has positive preliminary results from two Phase 3 clinical 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