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Phase 3 inhaled insulin data positive for type 1, type 2 diabetes

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Results from a phase 3 clinical study indicate an investigational, ultra rapid-acting mealtime insulin inhalation powder improved outcomes among patients with type 1 and type 2 diabetes, according to a press release.

The powder is administered using the manufacturer’s inhaler, also known as the Dreamboat inhaler. Peak insulin levels are achieved within 12 to 14 minutes of the drug’s administration, according to the press release.  

For patients with type 1 diabetes, insulin human rDNA origin (Afrezza, MannKind) demonstrated non-inferior decreases in HbA1c, significantly less hypoglycemia, decreased fasting blood glucose levels and provided significant weight advantages, compared with insulin aspart, according to the release.

In patients with type 2 diabetes, the drug significantly reduced HbA1c, postprandial glucose excursions and yielded no significant differences in severe hypoglycemia, combined with oral therapy and compared with oral therapy alone, according to the release.

In Study 171, researchers conducted a 24-week open-label study of patients with type 1 diabetes (n=518) on basal/bolus insulin therapy in the United States, Russia, Ukraine and Brazil.  According to data, HbA1c levels decreased in the Afrezza group by 0.21% and the insulin aspart group by 0.40% (between group difference=0.02% to 0.36%). These data indicate non-inferiority between the groups, according to the press release.  

Other results demonstrate the drug led to significantly less total hypoglycemia in the Afrezza group (9.80 events per subject-month) compared with the insulin aspart group (13.97 events per subject-month; P<.0001), according to the press release. Severe hypoglycemia was also lower in the Afreeza group (8.05 events per 100 subject-months) compared with the insulin aspart group (14.45 events per 100 subject-months).

Preliminary results also show that patients in the Afrezza group lost an average of 0.39 kg over 24-weeks compared with patients in the insulin aspart group who gained 0.93 kg, according to the press release.

The most common adverse event reported was cough during the first week of treatment.

For more information:

AFREZZA. MannKind Corp. Accessed August 14, 2013.