If taking insulin didn’t require a syringe, pen needle, or insulin pump…would insulin therapy be easier for patients with type 2 diabetes to embrace?

An oral insulin capsule has been developed and is currently undergoing phase-II patient trials in 24 different sites across the United States. 

While Novo Nordisk, Massachusetts Institute of Technology, Harvard, and Pfizer have all spent millions of dollars trying to create an oral insulin pill, none of them have succeeded so far.

Oramed Leads in the Development of Oral Insulin

Meanwhile, Oramed — a young company established in 2006 with a knack for making injectable medications successfully available in an oral form — is making major headway when it comes to insulin.

Co-founded by Nadav Kidron, CEO, and his mother, Miriam Kidron, Oramed’s oral insulin capsule is actually Miriam’s brainchild. 

Motivated by years of watching her husband struggle with diabetes, she was a determined researcher to make taking insulin easier for patients. Today, she serves as Oramed’s Chief Scientific Officer.

Michigan Testing

An oral insulin capsule has been developed and is currently undergoing phase-II patient trials in 24 different sites across the United States. 

One location where this oral insulin capsule is being tested is the AA Medical Research Center (AAMRC) in Michigan where approximately 1 million citizens have type 2 diabetes and another 2.7 million are likely facing prediabetes.

The Michigan site of Oramed’s patient trials consists of nine patients over the age of 18 with type 2 diabetes, an A1c of 7.5 percent of higher, and a body mass index less than 40. The patients cannot already be taking insulin but should be taking metformin because it improves the efficacy of insulin in general.

Seven of those nine patients have already completed the 90-day trial period, with the remaining two still actively finishing their trial. While this particular trial cannot advertise for participants based on FDA laws, they did have 16 patient volunteers from AAMRC and selected those who qualified.

So far, seven patients have already completed the 90-day tests. Two more patients are undergoing the tests. “Not everybody qualifies for the study. We had 15 or 16 volunteers. We are looking for patients who have poorly controlled diabetes and are not already on insulin,” Arif said

Why Developing an Oral Insulin Option is Crucial

Researchers have estimated that at least 25 percent of patients with diabetes aren’t taking the insulin they’ve been prescribed to bring their blood sugar levels down to a safer range. 

“It’s a big problem. Taking insulin orally could increase compliance because if they have a choice between a pill or a shot, they will take the pill,” said Ahmed Arif, M.D., owner, and director at AA Medical Research Center.

Between fear of needles and an impression from mainstream media that having to take insulin is a shameful step in living with diabetes, it’s not surprising patients resist it. 

But for many — whose blood sugars are rising because of gradual beta-cell dysfunction — taking insulin is the only option to truly improve blood sugar levels. 

In type 2 diabetes, approximately 60 percent of patients aren’t just insulin resistant, they’re also producing less insulin because the beta-cells — which are responsible for insulin production — are being destroyed. 

Research has actually shown that starting insulin earlier in the diagnosis of type 2 diabetes reduces stress on the pancreas and enables it to successfully produce more insulin.

But convincing patients to take injections is challenging when it doesn’t feel like a life or death situation compared to the need for insulin in those with type 1 diabetes.

If these patients don’t embrace insulin, they will inevitably struggle with high blood sugars, much to their own detriment and increasing risk of diabetes-related complications and death. 

How Oramed’s Oral Insulin Capsule Works

Creating insulin that can be ingested without being destroyed during the digestion process isn’t easy.

“Oramed has a special delivery system to protect the insulin, get it past the stomach to the liver where it can work,” explained Arif.

The special delivery system is a capsule that protects the insulin during the digestion process until it hits the intestinal wall where it is properly absorbed and can then enter the bloodstream. 

The result is better glucose control, reduced hyper, and hypoglycemia, and potentially less weight gain — and treatment can begin earlier thus improving outcomes,” added Kidron.

“There is a clear race to get the first technology for oral insulin,” he added. “Other companies are working on different products. Our formulation enables the insulin to get directly to the liver. This is the ‘natural’ way: from the pancreas to the liver.”

Realistically, based on the FDA process of patient trials, it will be a number of years before this potentially life-changing pharmaceutical develop is available to the greater public.