Tackling diabetes through new treatments, partnerships

Sanofi launches inhaled insulin for diabetics

UNTIL now, orally delivered insulin is difficult to develop because the protein gets broken down in the stomach. But a leading global pharmaceutical company has broken the barriers with the introduction of INSUMA, a leading Human Insulin product from Sanofi’s range of diabetes treatments. 

      Sanofi now provides a full range of both oral and injectable treatments for patients with diabetes in Nigeria.

       In Nigeria, it is estimated that around five million people are suffering from diabetes and this figure is expected to double within the next 20 years, with 63 per cent undiagnosed and many that are diagnosed, not correctly controlled. 

    Several studies have shown that 76 per cent of deaths due to diabetes are in people under the age of 60 on the African continent.

     Researches indicate that patients are exposed to many complications including vascular complications, blindness and limb amputation, which can be prevented by treatment with Insulin and effective, close management of patients. 

     Diabetes is a chronic disease that occurs when the pancreas is no longer able to make insulin, or when the body cannot make good use of the insulin it produces. Insulin is a hormone made by the pancreas, that acts like a key to let glucose from the food we eat pass from the blood stream into the cells in the body to produce energy. All carbohydrate foods are broken down into glucose in the blood. Insulin helps glucose get into the cells. Type 2 diabetes accounts for approximately 90 per cent of diabetes.

       It may remain undetected for many years and the diagnosis is often made when a complication appears or a routine blood or urine glucose test is done. It is often, but not always, associated with overweight or obesity, which itself can cause insulin resistance and lead to high blood glucose levels. People with type 2 diabetes can often initially manage their condition through exercise and diet. However, over time most people will require oral drugs and or insulin.

       Insulin is a key player in the complicated metabolic dance shared by nearly all organisms. Its importance can hardly be overstated. After a meal, animals and humans produce insulin in response to the increase in blood sugars that occurs as a meal is digested.

        This insulin stimulates the storage of circulating sugars into muscle and fat cells for future use. Too little insulin, or an inability of the body to respond correctly to its signal, causes a dangerous spike in blood sugar levels. 

     Conversely, too much insulin can cause a rapid drop. Both conditions can be life-threatening, and ongoing swings in blood sugar levels can lead to complications, such as blindness, poor circulation and kidney failure. 

     Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. 

       To better support the patients in the management of their disease, Sanofi has also announced their support in the opening of 12 dedicated diabetes and hypertension clinics in partnership with health authorities. The first clinic was recently inaugurated, at Lagos State University Teaching Hospital (LASUTH).

    Also, Sanofi has launched an inhalable insulin in the United States (US) on last Tuesday in a potential boost for its diabetes drug sales and for patient quality of life.

     Developed by Mannkind Corp, Afrezza will be the only inhalable insulin on the U.S. market, where Sanofi competes with Eli Lilly and Novo Nordisk for sales of traditional injectable insulin.

    Inhalation promises to be faster acting and much more convenient than injections, but an inhaled product has failed in the past and there are concerns about the potential risks associated with breathing powdered insulin.

      Afrezza, which uses a whistle-sized inhaler and works to control blood-sugar levels in both type 1 and type 2 diabetes, was developed in the shadow of Pfizer’s rival Exubera and approved by the United States (U.S.) Food & Drug Administration in June 2014.

      Exubera was approved in 2006 with expectations of $2 billion a year in sales but the inhaler was bulky, and patients were put off by the need for periodic lung function tests. Eventually it was withdrawn.

     General Manager, Sanofi Nigeria-Ghana, Abderrahmane Chakibi, said: “With over 90 years’ experience in developing and manufacturing Insulin, Sanofi is a world leader in delivering quality, innovative solutions to meet the needs of patients. The INSUMAN range allows for individualized treatment (basal, rapid and premix) available in both vials and cartridges.

      “The INSUMAN cartridges use a unique innovative technology that ensures a more accurate dosing. In Nigeria, it will be used with the award-winning ALLSTAR disposable pen for delivery. The introduction of INSUMAN in combination with ALLSTAR in Nigeria demonstrates our commitment to patients, improving access and ensuring availability to high-quality, efficacious solutions to improve the management of diabetes for patients.

      “INSUMAN has been licensed in 90 countries and is manufactured to the highest international standards in Germany. Since its first introduction 17 years ago, more than five million patient-years with INSUMAN have been accumulated.

      “Combining the range with ALLSTAR, a new, disposable, injection pen will help make the lives of patients easier in Nigeria with a simple, safe to use and affordable solution.”

      Commenting on the support of the 12 new clinics in diabetes, Chakibi added: “Delivering innovative treatments and a full portfolio adapted to the needs of patients locally is at the core of what we, at Sanofi, have done for nearly a century. But medications alone are not enough. For many years, we have been supporting healthcare professionals in their daily practice through training and tailored services.

     “In 2015, across Nigeria, we will support the creation of 12 clinics for Diabetes and 2/2 Hypertension in partnership with health authorities. These clinics will be established in dedicated healthcare centers to increase screening, disease awareness and patient education. They will also provide better management and monitoring of people with diabetes though dedicated nursing and physician support.”

     Chakibi added: “In 2016, we aim to deploy 24 more clinics. The availability of the new range of human insulin INSUMAN, the injection pen ALLSTAR and the support of clinics for the better management of the disease is in direct response to the healthcare needs of patients with diabetes in Nigeria.”

Meanwhile, scientists are hopeful that cells inside the human gut might someday be retrained to produce insulin, the metabolic hormone that’s lacking in people with type 1 diabetes.

        The team from Columbia University Medical Center in New York City said their findings hold promise for the development of a new treatment for type 1 diabetes that does not involve stem cells.

     For people with type 1 diabetes, their body’s natural insulin-producing cells, known as pancreatic beta cells, are destroyed by their immune system. For the past 20 years, scientists have been trying to help the body make new insulin-producing cells that replace those that are lost to the disease.

      Insulin-producing cells have been created before using stem cells, but these cells do not yet fully function like natural insulin-producing cells, the Columbia research team explained.

    However, by simply turning off a particular gene, the Columbia scientists were able to convert cells in the human gut into cells that make insulin. They said the findings suggest that “reeducating” existing cells may be an easier way to replace the cells lost in type 1 diabetes than creating new cells using stem cell technology.

     Meanwhile, a long-sought target in the treatment of diabetes is coming into focus, as researchers report the discovery of a molecule that inhibits the breakdown of insulin in mice.

    The compound, reported last year in Nature, blocks a protein called insulin-degrading enzyme (IDE) in mice. “If you inhibit the enzyme that breaks down insulin, insulin levels in your body should be higher and your blood glucose should be lower,” says David Liu, a chemical biologist at Harvard University in Cambridge, Massachusetts. And because people with type 2 diabetes tend to have low insulin levels, it could lead to new ways of treating the disease, he says.

     Although it was first reported 65 years ago2, IDE has proved difficult to inhibit. Most of the potential candidates were either too unstable to persist in the body, or lacked the specificity to block IDE without also blocking other important proteins.

    Liu therefore teamed up with his colleague Alan Saghatelian and with others to screen a wide range of molecules for those that are both stable and specific. They then tested the effects of the strongest candidate molecule in lean and obese mice given glucose.

    As expected, blood sugar levels dropped faster in those that received the inhibitor than in control mice, whether the mice were lean or obese. But the team also found something surprising: the IDE inhibitor had the opposite effect when the mice were injected with glucose rather than ingesting it.

    Liu and his colleagues suggest that the reason for the different responses could be that IDE also affects two other gut hormones that regulate blood sugar: amylin and glucagon. For example, mice that received the inhibitor had higher levels of glucagon, a hormone that boosts blood sugar levels, following glucose injection.

    However, mice that ingest glucose tend to have much higher insulin levels than mice that are injected with it, says Liu, so any effect on other hormones may simply have been drowned out by the proportionally large impact on insulin when glucose is ingested.

      Daniel Drucker, an endocrinologist at the University of Toronto in Canada, says that the results are exciting, but that he is concerned that the effects of the inhibitor on glucagon could impact its usefulness in treatment of diabetes. “The major unanswered question,” he says, is ‘What happens with chronic inhibition?’. You wouldn’t want glucagon levels to be high.”

    But Liu remains optimistic. “You could probably aim for a short-lived IDE inhibitor that is taken before a meal,” he says. “Most of us don’t inject our lunch.”

     Meanwhile, a hormone that decreases insulin production during starvation has been identified in fruit flies and humans. Modulating this activity could lead to new treatments for people with diabetes.

    Seung Kim and his colleagues discovered a hormone that tamps down circulating insulin levels in fruit flies recovering from food deprivation. They also found a protein with a similar function in humans.