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Oral Insulin Getting Closer to FDA Submission

Feb 6, 2014
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Could oral insulin be the type 2 diabetes treatment of the future?… 

Oramed, a company involved in making injectable medications into oral medications, is working on an oral insulin capsule. The insulin capsule recently underwent a small phase 2a trial in order to verify the medication’s safety. The trial was conducted over a week in the in-patient setting with 30 type 2 diabetic patients. The trial reportedly went very well and the company is looking to begin phase 2b trials shortly.

 

If this medication is approved it will be the first oral insulin capsule on the market. This could be a revolutionary medication for diabetics and may possibly take away many of the complaints patients have about insulin therapy. By having an oral form of insulin, patients may be more willing to begin insulin therapy at an earlier stage after their diagnosis.

Beginning insulin therapy earlier may have beneficial effects by allowing the pancreas to rest and perhaps retain its functionality for longer. Also, oral insulin seems to have less risk of hypoglycemia as compared to its injectable form. The company also reports that they will soon begin testing on the type 1 diabetic population at some time in the near future. Oramed reportedly foresees the oral insulin formulation being used initially as an adjunct to injectable insulin, thus allowing for less injections throughout the day.

Practice Pearls:
  • The first oral insulin capsule is currently undergoing phase 2a safety trials for type 2 diabetics, with phase 2b trial to follow shortly.
  • Oral insulin may be helpful for patients by beginning them on insulin therapy sooner, allowing the pancreas to rest and preserving its functionality for longer.
  • Oral insulin may have less risk of hypoglycemia compared to injectable insulin.

Oramed Press Release, Feb 2014