MannKind Corp. (MNKD)

[Denise Chanterelle]

I ran across this article recently. It's just 3 weeks old, so very relevant. Enjoy!

Diabetes Care Mag: Afrezza Lowers HbA1C in Uncontrolled Type 2 Diabetes
Afrezza Lowers HbA1C in Uncontrolled Type 2 Diabetes
Rachel Lutz
Published Online: Monday, August 31, 2015
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Adding Afrezza insulin inhalation powder to oral diabetes medications significantly reduces HbA1C in adults with poorly controlled type 2 diabetes.

To arrive at this conclusion, researchers recently examined more than 350 adults with type 2 diabetes and HbA1C levels between 7.5% and 10% who were taking metformin alone or at least 2 oral antidiabetes agents.

As an add-on to their oral regimen for 24 weeks, roughly half of the patients were randomly assigned to receive Afrezza, a prandial Technosphere inhaled insulin approved by the Food and Drug Administration (FDA) in June 2014 and launched by Sanofi and MannKind Corp in February 2015, while the remaining participants received prandial Technosphere inhaled placebo for the same time period.

Afrezza doses were titrated weekly based on glucose levels for the first 12 weeks to target 90-minute postprandial glucose levels of 110 mg/dL to 160 mg/dL. The participants could take a supplemental dose if their 90-minute postprandial glucose level was at least 180 mg/dL. For the remaining 12 weeks of the study, the researchers only adjusted doses for safety concerns.

The study results showed that Afrezza treatment reduced HbA1C by 0.8% from 8.3% at baseline, compared with the placebo’s 0.4% decrease in HbA1C from baseline. Significantly more inhaled insulin participants also achieved an HbA1C of less than or equal 7% than the placebo group.

As for changes in weight, the inhaled insulin group gained an average of 0.5 kg, while the placebo group lost an average of 1.1 kg.

Both participant groups experienced respiratory adverse events, the most common of which was a mild, dry cough (23.7% in the insulin group and 19.9% in the placebo group) that caused 1.1% of the insulin group and 3.4% of the placebo group to discontinue treatment in the study.

This treatment discontinuation resolved the slightly larger decline in forced expiratory volume in 1s that was seen in the Afrezza group compared with the placebo participants.
See more at: pharmacytimesDOTcom/news/afrezza-lowers-hba1c-inuncontrolled-type-2-diabetes#sthash.iH1dBypu.TzYZ5T8R.dpuf