Diabetes treatment could get a whole lot easier to swallow.

A research team at Syracuse University led by Dr. Robert Doyle, assistant professor of chemistry, has designed, tested, reproduced and patented a system for delivering insulin through an oral pill to rats. Their results will be published in the December issue of the pharmaceutical journal ‘ChemMedChem.’

The system could potentially be used by humans battling diabetes. Currently, individuals with diabetes must inject themselves with insulin to balance their blood sugar levels, which are not maintained because of unnatural output by the pancreas. With Doyle’s method, they could simply swallow a vitamin pill.

More than 21 million individuals in the United States have diabetes, yet taking insulin orally has not been possible because it must go through the gastrointestinal tract, which prevents it from reaching the bloodstream.

Being able to orally receive insulin would drastically change the lives of diabetics and the scope of the diseases’ treatment, researchers said.

The innovation in Doyle’s research is that they have found a way to attach the insulin to vitamin B-12. The vitamin protects the insulin as it journeys through the gastrointestinal tract in a ‘Trojan horse’ strategy.

‘It’s really like the holy grail of diabetes research…in terms of treatable things,’ said Tony Vortherms, a graduate student who worked on the project.

Vortherms was part of Doyle’s laboratory team that included Timothy J. Fairchild, an assistant professor of exercise science in the School of Education, and Amanda Petrus, a doctoral candidate and the project’s principle researcher.

Now the team will determine whether they can attach more insulin to the vitamin so that it can remain in the bloodstream for 12 hours. The ultimate goal would be for a diabetic to take two insulin pills a day – one in the morning and one at night – which would help them to maintain their metabolic control throughout the day, according to a news release announcing the discovery.

‘This would be a way to minimize the roller coaster of blood sugar levels the best we can,’ Vortherms said. ‘We still have a long way to go.’

The ultimate question is if and when this strategy can be used in humans.

‘There is a great deal that has to be done before clinical use,’ the principle researcher Petrus said. ‘We are excited but aware of the great amount of work left to do.’

It will probably take at least five years before a pharmaceutical company will take interest in the project – which has great commercial possibilities – and test it, Petrus said. The first stage would be a more elaborate test on rats and then trials to determine its effect in humans.

Petrus is optimistic.

‘From what I’ve seen so far,’ she said, ‘I do believe it’s possible.’

‘The goal of this project would be to give people who are not able to produce insulin on their own at least a base level of insulin in their blood,’ Vortherms said. He added that one of the biggest problems currently is the drastic swings in blood sugar levels that diabetics go through daily. The sugar highs and lows over the long term lead to wear and tear on the individuals.

The research began to seriously focus on insulin delivery a year and half ago, Petrus said, and they have been spending approximately 50 hours a week in the lab working on the project.

Doyle has had the idea of the Trojan horse delivery system since he was a graduate student at Yale University, and SU hired him specifically to work on it.

‘Dr. Doyle had been doing a lot of thinking about it for years – before he came to SU,’ Petrus said.

The delivery system was already being pursued simultaneously with other diabetes research, and the chemistry research already being conducted lent itself to diabetes treatment, Vortherms said.

‘He was interested in ‘the how’ and I think insulin just came in at the right time,’ said Vortherms, adding this research has the potential to go beyond diabetes.

‘I see it more of a team that’s changing the conversation of what’s possible,’ he said. ‘We’ve added to what people know they can do, and that’s a great feeling.’

Vortherms said he is very interested in the other fields in which oral delivery like this could work and added there was a ‘decent to good chance’ of it being used in humans in the future.

Neither Doyle nor Fairchild were able to comment Sunday. In the news release, Doyle said he was pleased because of the rare payoff in scientific research, where results must be tested and re-tested to ensure reproduction.

‘In the case of insulin, we had a hypothesis, we set about testing our hypothesis and we were rewarded for the effort,’ he said. ‘Having things go your way doesn’t happen in science often enough, so when it does it’s very rewarding.’

Fairchild sees the benefit of removing needles from the equation of diabetic treatment.

‘The possibility of having an oral insulin medication has tremendous feasibility, particularly with children and in less-developed countries where sterile needles and adequate training – for injection site and frequency, as well as needle disposal – may not always be available,’ he said.

He added that there is a lot of research being conducted in the field of diabetes treatment and other teams are looking at their own means for getting insulin into the bloodstream without the pain of injections.

All four researchers involved expressed excitement on the research, but also some hesitance because of the work left to be done before it could alter the lives of diabetics.

For Petrus, it is a personal endeavor. Her uncle has diabetes and some of her friends are exhibiting early signs of the disease. To ease their daily struggle motivates her.

‘It’s one of the driving forces of going to work every day,’ she said.

Published on October 21, 2007 at 12:00 pm