New medication for diabetes, including what’s in the pipeline for 2025
Credentialled Diabetes Educator Carolien Koreneff reviews new medications and treatments available, or soon to be available, for treating type 1 and type 2 diabetes.
New developments for people with (or at risk of) type 1 diabetes
Baricitinib
Baricitinib, also known as Olumiant, is a medication that is mainly used to treat rheumatoid arthritis. It is sometimes also used to treat severe hair loss and even COVID-19. Baricitinib works by blocking the action of Janus kinase enzymes, which are involved in the inflammation process. Baricitinib helps the immune system work better.
The Baricitinib in New-onset Type 1 Diabetes (BANDIT) study showed that people with type 1 diabetes who took baricitinib showed improved glucose levels and decreased insulin requirements, as well as preservation of beta cell function. Most participants still needed to take at least some insulin and needed to continue to monitor their glucose levels. But, after one year of treatment, it seems that the (off-label) use of baricitinib for type 1 diabetes may benefit some people if certain criteria are met.
The Australasian Type 1 Diabetes Immunotherapy Collaborative (ATIC) made several recommendations to healthcare professionals to guide the use of Baricitinib. These include pre-treatment tests to confirm the diagnosis of type 1 diabetes and the presence of residual beta cell function, and follow up tests to check the response after six months by measuring beta cell function, insulin use, CGM metrics and HbA1c. The ATIC statement also mentioned that baricitinib treatment would need to be ongoing. It is particularly important not to miss any doses, to sustain any of the benefits of the medication. However, there is currently no data on the treatment’s effect beyond a year.
Baricitinib is not recommended during pregnancy, for women planning to become pregnant, or while breastfeeding. Also, the use of Baricitinib would be off-label, which means that it is not covered by any PBS subsidy. A private prescription for 28 tablets is listed as costing $1046.
Januse kinase (JAK) inhibitors
There are two different treatments, also Januse kinase (JAK) inhibitors like Baricitinib, which are currently being trialled, in what is known as the JAK POT T1D study.
Abrocitinib and Ritlecitinib are being tested to see if they can preserve insulin production in younger people (aged 12-35) newly diagnosed with (stage 3) type 1 diabetes. Continuing to make even a small amount of insulin can help keep blood glucose levels in the target range, lowering the risk of long-term complications.
If either or both these treatments are successful, these JAK inhibitors may be studied in earlier stages of type 1 diabetes, to see if they can prevent or delay clinical diagnosis. For more information see: https://www.trialnet.org/our-research/newly-diagnosed-t1d/jakpot-t1d.
Lantidra
The Food & Drug Administration of America (FDA), has approved Lantidra (Donislecel), a new treatment for people with type 1 diabetes who experience frequent, severe hypoglycaemia.
This first-ever cell therapy works by infusing beta cells (the cells in the pancreas that produce insulin) from donors, into the hepatic portal vein. Once the newly infused beta cells start making insulin, the need for insulin injections, or insulin via pumps, may be eliminated. This transplanting of islet cells means that immune-suppressive medications are needed to avoid rejection.
Early data from the Lantidra trial showed that most participants gained some level of insulin independence. However, it is still uncertain if the benefits of Donislecel are greater than the safety risks. About 87% of study participants experienced infections, and there were complications after surgery, such as cuts on the liver, bruising of the liver, and anaemia.
Stem cell treatments
There are two main methods for generating new and functional beta cells: transplanting beta cells from human donors (for example Lantidra, as in the example above) and generating beta cells from stem cells.
Although both methods could be considered functional cures for type 1 diabetes, both methods require the person to take immune-suppressant medications (also known as anti-rejection medications) for the rest of their lives. This is to avoid these new beta cells from being attacked by the person’s own immune system, similar to how their original beta cells got destroyed.
However, researchers think that they may be able to alter the genetic code of implanted cells, so that they can avoid recognition by the immune system. This would mean that they may evade an immune system attack. Pre-clinical trials (done in test-tubes and on animals) had minimal side effects and seemed to be well-tolerated. Clinical trials are being conducted in this area, so watch this space for future updates. Find out more here.
New developments relating to both people with type 1 and people with type 2 diabetes
Needle-free insulin
An international team, led by researchers from Sydney University and Sydney Local Health District (SLHD), have developed an oral insulin which may offer a needle-free alternative to insulin in the future.
Previous attempts at making oral insulin failed as the tablets, or capsules, were either too large or broke down prematurely in the stomach. This new technology encapsulates the insulin in nano-carriers, particles 1/10,000th the width of a human hair. Scientists have created a special coating that protects the insulin from being broken down until it reaches the liver. Once the coating is broken down by liver enzymes (that are only active when the blood glucose levels are high), the insulin will either store glucose in the liver, as it would in people who do not have diabetes, or the insulin will enter the bloodstream to rapidly move to areas of the body that need it most.
It is said that this nanotechnology can lower blood glucose levels without causing a low blood glucose level. Interestingly, the new insulin can be eaten by taking a capsule or within a piece chocolate as they did in the trials on baboons.
Animal studies are completed and scientists are ready to trial this new insulin on humans in 2025. It will be at least a few years before needle-free insulin will be available commercially.
Microbiome
In the past 10 years or so lots of research has highlighted the important role microbes (micro-organisms) play. The human microbiome (communities of micro-organisms such as fungi, bacteria, and viruses), especially the gut microbiome, has been linked to multiple chronic conditions, including diabetes.
It may be a strange story, but Dutch researchers proved that transferring microbiome from a healthy person to the gut of a person with diabetes, through what is called a faecal transplant, can result in short-term improvement of insulin resistance. This has led to some companies trying to develop diabetes treatments that target the microbiome.
Microbiome research is still in its infancy and appears to be a difficult area of research; it is expected to take perhaps another decade for major developments in this space to result in readily available options.
New developments for people with (or at risk of) type 2 diabetes
Mounjaro
Mounjaro was approved by the TGA for the management in type 2 diabetes in 2023. It is now also approved for use in chronic weight management.
Additionally, Mounjaro is now available in a multi-dose, pre-filled pen device. It is important to note, that your pharmacist cannot dispense the Mounjaro KwikPen using a prescription for the vial, so if you are switching to the KwikPen you will need a new prescription.
Unfortunately, all strengths of Mounjaro vials will continue to be limited into 2025, “due to an unexpected increase in demand”. The TGA also reports that it is not known what impact the introduction of the Mounjaro KwikPen, and the new indication for chronic weight management, will have on the overall availability of Mounjaro products. The Medicine Shortage Reports Database lists the latest supply status of the different strengths available.
To help during the shortage of Mounjaro vials, the TGA has approved the temporary supply of an overseas-registered tirzepatide product, Mounjaro KwikPen (UK) and they recommend that, if patients are unable to fill their script for the correct strength or presentation of Mounjaro in time for their next dose, they should contact their doctor immediately to have their treatment plan reassessed.
PATAS
A French biotech company, is developing a medication called PATAS in conjunction with a team of international researchers, including some from Monash University in Melbourne. PATAS targets insulin resistance by rebooting how fat cells use insulin.
PATAS may have the potential to prevent the development of type 2 diabetes. It could also have other health benefits in chronic medical disorders caused by insulin resistance, including cardiac diseases, fatty liver, and the metabolic syndrome.
PATAS works by correcting an abnormality in fat cells by separating two proteins, which are associated with insulin resistance by blocking insulin from initiating glucose uptake. Early studies have shown PATAS to help these cells absorb glucose without needing insulin. Human clinical trials are likely to start in 2025. It could be delivered via a simple injection and possibly via a patch.
Rybelsus
Once-daily Rybelsus tablets are a prescription medication used to treat type 2 diabetes. The active ingredient in Rybelsus is Semaglutide, a glucagon-like peptide-1 (GLP-1) agonist. This means that it is the same active ingredient as the once weekly injectable GLP-1 medications Ozempic and Wegovy, but in a pill.
Rybelsus stimulates the pancreas to release more insulin when blood glucose levels are high and prevents the liver from making and releasing too much sugar. It also slows gastric emptying, which means food is slower to leave the stomach after eating. As such, Rybelsus is not suitable for people with type 1 diabetes due to the increased risk of hypoglycaemia associated with this delayed gastric emptying.
Rybelsus has the same potential side-effects as injectable Semaglutide: nausea, stomach pain, diarrhoea, decreased appetite, constipation, and weight reduction. This medication was approved by the Therapeutic Goods Administration (TGA) in February 2022, it is not known if or when it will be available in Australia, on the PBS.
Sidapvia
Australians with type 2 diabetes are able to access Sidapvia through the Pharmaceutical Benefits Scheme (PBS) as of November 2024. This new listing gives people with type 2 diabetes an additional treatment option.
Sidapvia is a combination medication that has both dapagliflozin (know as Forxiga) and sitagliptin (known as Januvia) in the one tablet. It should be used in combination with Metformin, and alongside a healthy diet and regular physical activity.
It does not normally cause hypoglycaemia, although users may experience a low blood glucose level if taking this medication in combination with certain other medicines, such as insulin or a sulfonylurea (for example gliclazide, glibenclamide or glimepiride).
Sidapvia is not recommended for use during pregnancy or when breastfeeding. It is also not recommended for use in children or in people with type 1 diabetes.
Interested in learning more about medications?
Our Managing diabetes course bite provides practical guidance on managing diabetes, helping you support your patients with confidence. By completing the course you will:
- Develop a thorough understanding of key diabetes medications
- Gain insights into healthy eating principles
- Recognise the benefits of physical activity in managing diabetes
Enrol today and gain valuable knowledge, CPD points, and practical skills to enhance your professional practice.