MIT scientists develop tortoise-shaped pill to deliver insulin

A blueberry-sized, tortoise-shaped capsule can replace the insulin injections administered to type 2 diabetes patients every day. A team led by Massachusetts Institute of Technology (MIT) researchers have developed a capsule that contains a small needle made of compressed insulin.

The tests conducted by researchers on animals showed the capsule could deliver enough insulin to lower blood sugar compared to those produced by insulin injections. Also, the MIT-led team found that the technique can used to deliver other protein drugs too.

“We are really hopeful that this new type of capsule could someday help diabetic patients and perhaps anyone who requires therapies that can now only be given by injection or infusion,” says Robert Langer, the David H. Koch Institute Professor, a member of MIT’s Koch Institute for Integrative Cancer Research, and one of the senior authors of the study.

Other authors of the study had, several years ago, developed a pill coated with many tiny needles that could be used to inject drugs into the stomach’s lining or the small intestine. The researchers changed the new capsule so it has just one needle so that the drugs aren’t injected into the stomach’s insides and broken down by acids before they could have any effect. The new capsule’s tip is made of absolutely compressed and freeze-drilled insulin and its shaft is biodegradable too.

It is designed in such a way that the needle inside the capsule is attached to a compressed spring held in place by a disk made of sugar. Once it’s swallowed, the sugar disk dissolves and releases the spring injecting the needle into the stomach wall.

The researchers say patients won’t feel any pain from the injection as the stomach wall has no pain receptors. “As soon as you take it, you want the system to self-right so that you can ensure contact with the tissue,” Giovanni Traverso, an assistant professor at Brigham and Women’s Hospital, Harvard Medical School, and a senior author of the study says.

The researchers’ inspiration was the leopard tortoise that has a shell with a high, steep dome, allowing it to right itself if it rolls onto its back. The pill is a variant of its shape made using computer modelling since it allows the capsule to reorient itself in the stomach.

“What’s important is that we have the needle in contact with the tissue when it is injected,” Abramson says. “Also, if a person were to move around or the stomach were to growl, the device would not move from its preferred orientation.”

The team is working with pharmaceutical company Novo Nordisk to develop the technology and optimise the manufacturing process for the capsules. “Our motivation is to make it easier for patients to take medication, particularly medications that require an injection,” Traverso says. “The classic one is insulin, but there are many others.”

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Insulin injections are linked to weight gain and the loss of control of blood sugar levels

While the kind of food one eats and even the order in which it is consumed can affect the health of an individual. A new study finds that a starch-rich breakfast consumed early in the morning coupled with a small dinner could replace insulin injections and other diabetes medications for many diabetics.

Type 2 diabetics inject themselves with insulin, a hormone that regulates the movement of sugar into liver, muscle and fat cells, up to four times a day. But insulin injections are linked to weight gain and the loss of control of blood sugar levels. This triggers a vicious cycle of higher insulin doses, continuous weight gain, a higher incidence of cardiovascular disease and other complications.

According to the new research, our metabolism and biological clock are optimised for eating in the morning and for fasting during the evening and night, when we are supposed to be asleep. Prof. Daniela Jakubowicz of TAU's Sackler Faculty of Medicine and Wolfson Medical Center's Diabetes Unit said, "But the usual diet recommended for type 2 diabetes consists of several small meals evenly distributed throughout the day, for example, three meals and three snacks daily, including a snack before going to sleep to prevent a drop in sugar levels during the night."

The research was published in the journal Diabetes Care. According to Prof. Jakubowicz "The traditional diabetic diet specifies six small meals spread throughout the day. But our research proposes shifting the starch-rich calories to the early hours of the day. This produces a glucose balance and improved glycemic control among type 2 diabetics."

Thus explaining the reason behind this theory of diet as "We believe that through this regimen it will be possible for diabetics to significantly reduce or even stop the injections of insulin, and most of the anti-diabetic medications, to achieve excellent control of glucose levels."

Prof. Jakubowicz added.”But the '6M-diet,' as this is called, has not been effective for sugar control, so diabetics require additional medication and insulin. And insulin injections lead to weight gain, which further increases blood sugar levels,"

The researchers studied 29 type 2 diabetes participants and compared a new "3M-diet," more in alignment with our biological clock, with a control group on the traditional 6M-diet. The experimental 3M-diet comprises a meal of bread, fruits, and sweets in the early hours of the morning; a substantial lunch; and a small dinner specifically lacking starches, sweets, and fruits.

The group on the traditional 6M-diet did not lose weight and did not experience any improvement of sugar levels, requiring an increase in medication and insulin doses. But the group on the 3M-diet not only lost weight but also experienced substantially improved sugar levels.

Prof. Jakubowicz is of the view, "In addition, the 3M-diet improved the expression of biological clock genes. This suggests that 3M-diet is not only more effective in controlling diabetes. It may also prevent many other complications such as cardiovascular disease, ageing, and cancer, which are all regulated by the biological clock genes."

The upregulation of the biological clock gene expression in the 3M-diet might be the mechanism behind its success, as it enhances insulin secretion and improves sugar delivery into the muscles, creating a balanced daytime and nocturnal glucose metabolism. The researchers are now investigating the role certain proteins play in breakfast foods consumed by diabetics.

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No More Needles: New Diabetes Treatment in a Pill Approved

Diabetes has been on the rise for decades, with an estimated 422 million worldwide suffering from the condition as of 2014 according to the WHO. The majority of these patients suffer from the acquired form of the disease, known as type 2 diabetes, which is notorious for being undiagnosed for years. Until recently, the treatment of type 2 diabetes in its advanced stages, for the majority of patients, was limited to injections, which are invasive, painful, and significantly more expensive than oral medications. Luckily, that is about to change, as a new treatment of the disease has recently passed FDA approval.

The drug in question is called Rybelsus, and it belongs to a group of glucagon-like peptide (GLP-1) drugs, which are sometimes prescribed to patients who can no longer control their blood sugar with diabetes medications that come in pills. These drugs typically come in injections, as the active ingredients of these medications are destroyed by stomach acids.

Rybelsus is the first drug of this kind to come in tablet form, and it has been approved as a standalone or complementary treatment of type 2 diabetes.

The tablets will be taken daily 30 minutes before food in the morning. Though the pricing of the new drug will be comparable to similar injectable treatments, the new medication can help relieve the psychological and financial burdens for many diabetes patients, as they will no longer require painful injections and will ultimately save money on syringes. Given that type 2 diabetes is a chronic disease and patients require daily or weekly injections for years on end, this is a major improvement.

The effectiveness and safety of Rybelsus have been proven in several clinical trials and established that it can stabilize blood sugar levels in type 2 diabetes patients. The medication is not advised to treat type 1 diabetes, and the FDA doesn’t recommend Rybelsus as the first choice of treatment because it may increase the risk of a specific type of thyroid tumors as a side effect.

Still, the developers of the drug, Novo Nordisk, predict that it will become the treatment of choice for many patients and will lead the way in producing other novel treatments that are currently only available in injection form.

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Novel pill could replace injections to deliver insulin

Researchers have developed a drug capsule that could be used to deliver oral doses of insulin, potentially replacing injections for patients with Type-2 diabetes, says a new study.
About the size of a blueberry, the capsule contains a single and small needle made of compressed insulin, which is injected after the capsule reaches the stomach. 
The study showed that the capsule could deliver enough insulin to lower blood sugar to levels comparable to those produced by injections given through skin. They also demonstrated that the device can be adapted to deliver other protein drugs.
"We are really hopeful that this new type of capsule could someday help diabetic patients and perhaps anyone who requires therapies that can now only be given by injection or infusion," said a researcher.
The tip of the needle is made of nearly 100 per cent compressed, freeze-dried insulin. 
When the capsule is swallowed, water in the stomach dissolves the sugar disk, releasing the spring and injecting the needle into the stomach wall.
The stomach wall has no pain receptors, so the patients would not be able to feel the prick of the injection. To ensure that the drug is injected into the stomach wall, the researchers designed their system so that no matter how the capsule lands in the stomach, it can orient itself so the needle is in contact with the lining of the stomach.
The findings, published in the journal, showed that the researchers could successfully deliver up to 300 micrograms of insulin. 
More recently, they have been able to increase the dose to 5 milligrams, which is comparable to the amount that a patient with Type-2 diabetes would need to inject.
Furthermore, no adverse effects from the capsule was found, which is made from biodegradable polymer and stainless steel components.
Importantly, this type of drug delivery could be useful for any protein drug that normally has to be injected, such as immuno-suppressants used to treat rheumatoid arthritis or inflammatory bowel disease and may also work for nucleic acids such as DNA and RNA, according to the researchers.

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For The First Time, Scientists Turn Human Stem Cells Into Insulin-Producing Cells

Although treatment of type 1 diabetes has come a long way since it was first described in Ancient Egypt, insulin injections and finger pricks are a daily part of life for many diabetics.

But researchers have just made a breakthrough that might one day make these technologies obsolete, by transforming human stem cells into functional insulin-producing cells (also known as beta cells) – at least in mice.

"We can now generate insulin-producing cells that look and act a lot like the pancreatic beta cells you and I have in our bodies," explains one of the team member.

"This is a critical step towards our goal of creating cells that could be transplanted into patients with diabetes."

Type 1 diabetes is characterised by a loss of insulin due to the immune system destroying cells in the pancreas - hence, type 1 diabetics need to introduce their own insulin manually. Although this is a pretty good system, it's not perfect.

People with the condition can live mostly normal lives, but they do have an increased risk of problems such as kidney failure, heart disease, and stroke.

There are other methods of managing type 1 diabetes, such as introducing new beta cells or swapping out the damaged pancreas for a new one, but both of these options have limited availability, as the new cells or organs need to be taken from organ donors.

To get around the donor problem, researchers including the team  has been working on nudging stem cells into becoming fully functional pancreatic beta cells for the last few years, but there have been some issues in getting them all the way there.

"The cells we and others were producing were getting stuck at an immature stage where they weren't able to respond adequately to blood glucose and secrete insulin properly," he said.
"It has been a major bottleneck for the field." 

But when the team looked at the way these cells develop in the pancreas, they struck gold. Here, the cells separate from the rest of the pancreas and arrange themselves into protrusions called pancreatic islets.

The team investigated this process in a petri dish, artificially separating the pancreatic stem cells to reorganise them into the islet-like clusters they naturally form in the body. This arrangement allowed the pancreatic stem cells to mature and function much like regular insulin-producing cells do.

And even better, when these islets were transplanted into healthy mice, they found that the cells produced insulin in response to blood sugar levels in a matter of days.

Of course, as with any mouse study, we can't get too excited just yet - there's still quite a bit of work to be done before this becomes a helpful treatment for humans. For one, if you were to introduce new pancreatic stem cells into a type 1 diabetic, it's likely that the immune system would still destroy them.

This means that anyone undergoing this treatment would have to be on immune suppressors for the rest of their life, an issue that also comes with organ and cell donations.

But this latest step is still a huge step forward, and the team is now working on solving these other problems. For example, they are investigating whether CRISPR can be used to change the stem cells enough that they could fly under the radar of the overactive immune system.

"We're finally able to move forward on a number of different fronts that were previously closed to us," he added. "The possibilities seem endless."

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Pancreatic cancer symptoms: Diabetes could be a warning sign for deadly disease

DEVELOPING diabetes could be an early warning sign of pancreatic cancer, experts have revealed. 

Pancreatic cancer  is hard to diagnose in its early stages as the tumour doesn't usually cause any symptoms.

The disease affects around 8,800 people every year in the UK.
Diabetic have an increased risk of pancreatic cancer - however now experts have suggested cancer can cause some cases of diabetes.

Experts have revealed the onset of diabetes, or existing diabetes getting much worse could be a sign of hidden pancreatic cancer.

Medical records and the type of diabetic medicines they are prescribed could be a tool in identifying those at risk, scientists from the International Prevention Research Institute in Lyon said.

An analysis of nearly a million patients with type 2 diabetes in Italy and Belgium with pancreatic cancer found half were diagnosed within one year of being found to have type 2 diabetes and being given their first prescription to control it.

Experts said they had a 3.5 times greater risk of being diagnosed with the disease in the first three months after their first prescription for incretins, hormones which stimulate the pancreas to produce more insulin to lower blood sugar levels.

Injecting insulin was associated with a seven-fold increased risk of being diagnosed with pancreatic cancer.

Professor Philippe Autier said: "Although it has been known for some time that there is an association between type 2 diabetes and pancreatic cancer, the relationship between the two conditions is complex.

"Incretin therapies reduce diabetic hyperglycemia through stimulating the release of insulin by the pancreas.

"These drugs are typically prescribed when the oral anti-diabetic drugs can no longer control blood glucose levels.

"Because of their stimulating effects on the pancreas, it has long been thought that the incretin therapies could promote the occurrence of pancreatic cancer.”

Professor Artier said while it is known that pancreatic cancer can cause diabetes, but the study shows treatment for diabetes is often prescribed to patient whose diabetes is caused by undiagnosed cancer.

He explained: ”Because the pancreatic cancer finally becomes symptomatic and is thus diagnosed, it looks like it is the intake of incretin drugs that could be the trigger of the pancreatic cancer, while in reality, it is the pancreatic cancer that causes a deterioration of diabetes, which is followed by the prescription of incretins.

"This phenomenon is called 'reverse causation'.

"Our study also shows that the reverse causation observed for incretin drugs is also observed for other anti-diabetic therapies, in particular for insulin therapy.

"Doctors and their diabetic patients should be aware that the onset of diabetes or rapidly deteriorating diabetes could be the first sign of hidden pancreatic cancer, and steps should be taken to investigate it."

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New device for diabetics ensures that patients miss fewer insulin doses

A new device known as OneTouch is an on-demand insulin delivery system in development that helps diabetics discreetly with their treatment.

 While syringes, pens, insulin pumps and jet injectors have given diabetics options for their insulin delivery for many years now, a new device called OneTouch Via could change the game.

People with type 1 and type 2 diabetes who used the new OneTouch Via mealtime, on-demand insulin delivery system reported they missed fewer doses and felt less stress about dosing compared to multiple daily injections, according to research presented by Calibra Medical, Inc., one of the Johnson & Johnson Diabetes Care Companies, at the annual American Diabetes Association (ADA) conference.


Results of the Market Acceptance Evaluation (MAE) study also demonstrated that physicians were more likely to recommend the innovative insulin delivery device to patients who are not at A1C goals or who are new to rapid-acting insulin (RAI) therapy.

The new OneTouch Via is a wearable, on-demand insulin delivery system in development that allows patients to discreetly deliver rapid-acting, or bolus, insulin at mealtimes by simply pressing two buttons on the device, accessible even through clothing. The thin, water-resistant patch can be worn continuously for up to three days, providing injection-free delivery of insulin when needed.

‘People with diabetes can often feel embarrassment or discomfort when they need to inject insulin at mealtimes or when snacking. In a social situation, they may choose to miss a dose so they don’t have to take themselves out of the moment, but avoiding needed insulin doses may lead to serious health complications over time,’ said Dr. Brian Levy. 

Levy added, ‘Because patients in the study were empowered to dose discreetly with the OneTouch Via, they felt encouraged to dose more often – and ultimately, they reported missing fewer doses and better adherence to their treatment regimen.’

The healthcare professionals who assisted with the study noted that they preferred the OneTouch Via over both insulin pens and syringes (75 % and 100 %, respectively) and would be likely to recommend it to their patients. The doctors also reported that they would start patients on mealtime insulin earlier because of the ease of use of the OneTouch Via patch. The study appears in American Diabetes Association (ADA) Conference.

 Read: Keep your insulin levels in control to keep your lungs healthy

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India gets its first 'weekly' injectible drug for Type 2 diabetes

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 Diabetes is one of the most haunting diseases to prevail in the world. In India, the number of patients suffering from the same is increasing day by day. Out of the two types of diabetes, it is believed that Type 2 diabetes occurs in 80% to 90% of the patients worldwide.

 Most of these patients on a daily basis have to inject insulin in order to keep their sugar levels under check, which proves to be more than a painful process for many patients.


Diabetes is also known to have a negative affect on kidneys where in patients are advised to undergo dialysis, which again is a painful, time consuming and money spending process. Eli Lilly and Company (India) Pvt. Ltd. announced today the launch of its recently approved diabetes treatment Trulicity (dulaglutide) in India. Trulicity is the first once-weekly, injectable medication designed to improve blood sugar control in adults with type 2 diabetes.

Trulicity is part of a class of drugs known as a glucagon - like peptide (GLP-1) receptor agonists. It is not insulin and mimics the effects of GLP-1, a natural hormone that helps keep blood sugar levels normal, by helping the body release its own insulin after food intake. It comes in an easy to use, single-dose pen that does not require mixing or measuring and can be administered at any time of the day, independent of meals.

"Diabetes is a big burden on the healthcare system in India. Millions of Indians live with diabetes and have diverse needs", said Edgard Olaizola, Managing Director, Lilly India. He added, "Trulicity is an important addition to our diabetes portfolio in India and this launch is an important milestone in our journey to help a large number of patients and their caregivers.

India is among the first few countries in the world and only third in Asia (after UAE and Japan) to launch Trulicity. It received US FDA approval in September 2014 and EU approval in November 2014. However it must always be remembered that Trulicity is a prescription drug that should be taken only on prescription from a registered MD (Internal Medicine) and Endocrinologist.

Will these insulin-producing mini stomachs replace insulin injections for diabetes?

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Many diabetics have to be dependent on insulin injections to prevent the complications of diabetes, but scientists now have successfully developed mini-organs that will deliver insulin whenever needed and can make way for patient-specific therapy for diabetics.

In a bid to replenish insulin-producing beta cells, scientists from the University of Harvard discovered that the tissue from the lower stomach in mice has the greatest potential to be turned into beta cells. After taking samples if this tissue from mice, they grew them into mini-organs that produced insulin once transplanted back into mice. The study was published in the journal Cell Stem Cell.
 
Qiao Zhou from Harvard explained that the tissue from the pylorus region of the mice is the easiest to convert to produce beta cells, and the tissue is the best starting material. The cells in the pylorus region were most responsive to high glucose levels and produced insulin to normalise the mouse’s blood glucose. The verify the effectiveness of the tissue, the scientists destroyed the mice’s pancreatic beta cells which forced the body to rely completely on this implanted tissue to produce insulin. (Read: A diet plan diabetics can use for better blood sugar control)
For the study, there was a set of control animals did not contain reprogrammed tissue. These mice died within eight weeks.  The mice with reprogrammed cells could maintain glucose and insulin levels as long as six months.

Once implanted, the stem cells from the converted tissue replenished the insulin-producing cells increasing the sustainability of the tissue. To confirm their finding, the scientists destroyed the genes responsible for the conversion and found that the region’s stem cells replenished the insulin producing cell population. 

After isolating the tissue from the stomach, the researchers converted it to express beta cell reprogramming factors in the lab and then coaxed the cells to grow into a tiny ball of stomach that would not only produce insulin and refresh itself with stem cells. This mini stomach was then transplanted into the mice’s abdominal cavity. Out of the 22 experimental animals, five animals exhibited normal glucose levels after the destruction of their pancreatic cells.

Researchers explained that using this approach; one can biopsy from a person, grow the cells in the lab, convert them to produce insulin and then transplant them back to create a patient-specific therapy.