The diabetes community has reason to be skeptical of anything claiming to be the next big thing. Claims of diabetes breakthroughs seem as frequent as they are strange (we’ve reported on both blind cave fish and platypus venom furthering diabetes research). But insulin that you can take by mouth? That seems in the realm of possibility, right?
The idea is attractive, but realization has eluded hopeful scientists for decades. But now one company, Oramed, has started a large clinical trial on an oral insulin that, if successful, would be one of the final steps before seeking FDA approval and subsequent marketing, i.e., availability to real people—people whose lives could be changed by the availability of oral insulin.
What Oral Insulin Could Mean
An insulin pill would be more than just convenient. Oral insulin would more closely mimic insulin’s natural behavior because it would travel more directly to the liver. Injected insulin travels through the bloodstream’s general circulation and gets to the liver eventually. Getting insulin to the liver more quickly via the digestive system could mean faster insulin action and better absorption of glucose. A reduced risk of excess insulin in the blood would also reduce risk of hypoglycemia.
Oramed is quick to point out oral insulin’s other potential benefits:
- For those with type 2 diabetes, starting insulin therapy early decreases the burden on the pancreas, which could help the pancreas produce insulin longer. But injectable insulin is seen as a last resort because of the risk of hypoglycemia and weight gain. Oral insulin therapy would be safe to start sooner.
- Injected insulin is more likely to cause weight gain because only part of it reaches the liver, which contributes to excess sugar being stored in the fat and muscle tissue. Oral insulin solves this by getting to the liver more efficiently.
- Oral insulin would likely improve patient adherence and therefore contribute to better diabetes management and better outcomes.
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The attractiveness of oral insulin is obvious. Why would anyone want to inject insulin if they could just manage blood sugar with pills? The problem is that insulin is a protein chain or peptide hormone, and your stomach acid stands ready and willing to break down proteins. To be effective, oral insulin has to be protected in some way so that it can make it through the stomach before it can be absorbed into the bloodstream via the intestines.
The intestines offer new challenges. The intestinal wall is thick, and previous studies have shown that only low levels of insulin can successfully pass from intestines to bloodstream. Some researchers have raised safety concerns about the effect of insulin, a growth-promoting substance, going through the digestive system on a long-term basis.
The New Product
But Oramed’s earlier trial, involving 180 participants taking their product for 28 days, demonstrated that the product was safe (at least for 28 days) and effective in lowering HbA1c. The 90-day trial began in May 2018, involved 240 participants across the US, and was conducted under the direction of the FDA.
Oramed CEO Nadav Kidron shared his excitement in a company press release: “This is our most important study to date. A year from now we will better know the potential of our drug to control and maintain blood glucose levels and will have further proof of the longer-term benefits of taking an oral pill versus an injection,” he said. Data from the trial should be available in early 2019 and, if it’s positive, will lead to the final FDA studies needed for approval.
For Kidron, the project is personal. “My father suffered from diabetes and it was my mother’s mission to find an alternative way to deliver insulin,” he said. Kidron founded Oramed as a way to make his mother’s dream a reality.
What Else Is In The Works…
A study published in July 2018 found a way for oral insulin to lower blood glucose in rats, but it’s behind Oramed’s product as it still needs to undergo further animal studies. And there are other companies hopeful of cracking the case on oral insulin: Diasome Pharmaceuticals and Diabetology both have phase 2 trials underway for oral insulins.
The bad news is that there’s still time to discover that the oral insulins currently in the works are fraught with concerns about long-term safety or reliability. Even if it’s eventually made available, if the product proves less effective than injected insulin (though Oramed thinks it will be more effective), the product may not be commercially viable. Most people with diabetes and their doctors will still prefer a safe, reliable injection over something ineffective or impractical, as turned out to be the case with inhaled insulin.
Still, as the slow pace of pharmaceutical science inches toward oral insulin, there is reason to be hopeful. Oramed has delivered more than just an exciting study done on a few unlucky lab rats—this is the real deal, and other companies are following hungrily behind them. It’s hard not to be hopeful; a viable oral insulin could actually be on the way. Now that’s a pill we could swallow.Whizzco