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Dana Staat, PharmD Clinical Pharmacy Lead-Internal Medicine Spectrum Health, Grand Rapids, Michigan May 2015

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This speaker has no actual or potential conflicts of interest to disclose in relation to this presentation

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Discuss the mechanism of distribution of the new medications being developed and approved for the treatment of diabetes. List the potential benefits of treating diabetes with the diabetes medications in development. List the drawbacks to treating diabetes with the diabetes medications in development.

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Almost 26 million Americans are affected by DM Seven million Americans are unaware they have DM 79 million people may have pre-diabetes Per the CDC, DM is the 7 th leading cause of death in the US Over 75,000 deaths in the US per year Death rates have fallen by up to 40% since 1997 New DM diagnosis has more than tripled since 1980 National Diabetes Fact Sheet, 2011. US Centers for Disease Control and Prevention (CDC). www.cdc.gov

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Cost of diabetes in 2012: $245 billion Direct medical costs: $176 billion Reduced productivity: $69 billion Increase in 41% since 2007 Average medical expenses are 2.3x higher in patients with diabetes Economic costs of diabetes in the US in 2012, American Diabetes Association (ADA), www. Diabetes.org

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Discovered in 1921 One of the most studied molecules in history First hormone to be cloned and produced via DNA technology Made insulin supply unlimited Full therapeutic potential is still not optimized

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New medications in development for DM or related diseases: 180 128 for DM 52 for related diseases Clinical trials: 200 140 recruiting patients 60 active trials Medicines in Development-2014 report. Pharmaceutical Research and Manufacturers of America. www.phrma.org/sites/default/files/pdf/diabetes 2014.pdf. Accessed on 4/16/15.

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Short-acting Insulin Inhaled Insulin (Afrezza ) Long-acting Insulin PEGylated lispro insulin Insulin glargine 300 Units/mL (Toujeo ) Insulin degludec (Tresiba )

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Oral Buccal Nasal Ocular Transdermal Rectal Uterine Vaginal

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Novel drug delivery First investigated in 1924 Large surface tissue area Alveolar deposition

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Marketed in 2006 Removed from the market in 2007 Disappointing profit margin Dosed in mg vs units Available in 2 strengths Large device Small decrease in FEV1 FDA-warning regarding lung cancer http://www.nature.com/nbt/journal/v2 5/n12/full/nbt1207-1331.html

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Approved July 2014 Dry powder, human, regular insulin Adsorbed onto technosphere microparticles (TI-technosphere insulin) Carrier is fumaryl diketopiperazine (FDKP) Inert excipient Dissolves immediately when inhaled

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Ultra rapid acting insulin Peak-15 minutes Regular insulin Bioavailability varies depending on inhaler technique (21-30% of SubQ) Cartridges of 4 units or 8 units Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.

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Insulin nave 4 units Afrezza with each meal On mealtime insulin Use chart Afrezzapro.com

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Affinity 1 DM1 Basal insulin present Compared to SubQ aspart Verified efficacy of Dreamboat inhaler Change in A1C met noninferiority, but favored aspart More patients in aspart group achieved A1C