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Thursday, 15 November 2018

New treatments for diabetes: Alternatives to insulin?

New drugs to eliminate the need for insulin injections are urgently needed by diabetes patients worldwide and scientists are working to develop alternatives

Nevine El-Aref , Saturday 27 Jan 2018
Insulin
Quality Control in "Insulin City", Frankfurt
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Since 1920 when insulin was first used to treat diabetes, no other treatment has been invented to control patients’ blood sugar. However, today new treatments are in the pipeline.

In a conference held at “Insulin City” in Frankfurt, Germany, recently, research related to the development of new treatments for type one and type two diabetes was presented.

The conference was held under the auspices of French drug company Sanofi, the owner of the site, in an attempt to promote global awareness about diabetes and identify the most important drugs used to treat it. The event was attended by specialists in the field of diabetes research and treatments.

Diabetes is a chronic disease with serious long-term health implications that can require complex lifestyle adaptations, including the need to follow life-long treatment. Diabetes can be complex to manage on a daily basis, requiring regular blood glucose (HbA1c) measurements, careful monitoring of food intake, weight, regular physical activity and adherence to a strict medication schedule.

Patients may fear complications relating to the disease and the potential side effects of therapies. To help patients deal with diabetes, tailoring therapies to physiological requirements and recognising a concurrent requirement for lifestyle and psychological support are required.

In a healthy person, insulin is released by beta cells to allow the body to use glucose obtained from food to provide energy, thereby lowering blood glucose levels. In the body blood glucose levels are jointly controlled by insulin from beta cells in the pancreas and glucagon produced in pancreatic alpha cells.

Jean-Marc Chantelot, a researcher with Sanofi, explained that there are two types of diabetes: type one and type two. Type one diabetes is an autoimmune condition resulting from the absence of insulin production, while type two diabetes is a metabolic disorder resulting in the reduced ability of the body to respond to the insulin being produced.

People with type one diabetes require external supplementation of insulin via injections in order to control their blood glucose.

“The management of type one diabetes can be challenging, particularly because people are normally diagnosed at a young age,” Chantelot said. He added that it was important to bear in mind the psychological burden of the condition, as young people can find it difficult to manage diabetes alongside the normal changes and lifestyle adaptations they face as a part of growing up.

Type two diabetes starts when the body becomes resistant to insulin, which raises the levels of glucose in the blood, which in turn damages the tissues, organs and blood vessels.

“Managing type two diabetes appropriately is critical in order to control its progression and to prevent acute and long-term complications that may develop as a result of poor glucose control,” Chantelot said. He added that if blood glucose remains uncontrolled after lifestyle interventions, oral glucose-lowering medicinal products are prescribed as a first-line treatment, followed by injectable treatments such as basal insulin or GLP-1 receptor agonists.

A key goal in the management of type two diabetes is achieving a target HbA1c level of less than seven per cent (non-pregnant adults), as this has been proven to reduce complications.

The UK’s Prospective Diabetes Study (UKPDS), a long-term study of the disease, has showed that reducing average blood glucose results in a significant decrease in the risk of heart attack or diabetes-related death. According to statistics from the International Diabetes Federation (IDF), four million people die of diabetes each year, although global health spending has reached $727 billion to treat them. This amount could increase to $802 billion in 2045.

The same statistics reveal that an estimated 425 million people worldwide have been diagnosed with diabetes, with the Western Pacific topping the list. This has 159 million patients with diabetes, while Southeast Asia has 82 million, Europe 58 million, North America and the Caribbean 46 million, and the Middle East and North Africa 39 million. Sub-Saharan Africa has 16 million, and South and Central America 26 million.

According to IFD predictions, the number of patients with diabetes worldwide will increase to reach 629 million by 2045. “Diabetes poses more of a public health concern than ever before, especially in developing countries. This is largely due to the rise of obesity and sedentary lifestyles. No fewer than three-quarters of diabetics live in low- and middle-income countries,” Chantelot said.

Insulin
Production of insulin pens

LIVING WITH DIABETES

“The shock was not the diagnosis, as I was not old enough to understand that at the time. The real shock was the daily injections,” recalled Ahmed Ihab, a 20-year-old marketing student from Egypt who was diagnosed with type one diabetes at the age of 12.

“Often, parents are sad that their child has been diagnosed,” he said, adding that “I tried to make them realise that it was not the end of the world and that diabetes was never going to hold a person back. If it is managed well, you can do anything,” Ihab confirmed.

He said that taking insulin every day, eating a healthy and balanced diet that follows his diabetes meal plan, as well as checking his blood sugar levels several times a day, had all helped him live a good life. “It is not easy, but it is worth it,” Ihab said.

Things may be different for type two diabetes patients. A recent study in the UK scientific journal The Lancet suggests that following a diet that confines calorie consumption to fewer than 1,000 calories per day can reverse the disease in some individuals without using conventional treatments. The treatment had been successful in people who had been living with diabetes for more than six years, it said.

Researchers working on the study said that after trials on patients with diabetes, a low-calorie diet caused remission in 90 per cent of those who had lost 15kg or more, even those who had been diabetic for six years.

For those who do not want to try a low-calorie diet, an older management technique of the disease is recommended through healthy food choices that are low in fat and rich in fibre. They should drink water instead of juice, stay at a healthy weight, move more every day, stop smoking and take their medicine even if they do not feel unwell.

Patients should also learn ways to lower their stress because this could raise their blood sugar. They can try deep-breathing, taking a walk, meditating, working on their hobbies or listening to their favourite music.

However, the good news is that new treatments could be coming. Klaus Jensen, therapeutic area head for Sanofi’s Insulin City, told Al-Ahram Weekly that there are three new exciting drugs in the pipeline, one of them dedicated to type one diabetes. The treatments work by increasing the amount of glucose that is excreted through the urine and reducing the amount of glucose taken into the body.

“For diabetes type one, a new therapy was developed and completed this year,” Jensen said, adding that next year the company was planning to apply for the approval of this drug for youth-onset type one diabetes. “If we are successful, and of course we expect to be, the drug will be launched on the market,” he said.

“It would be the first drug to be approved for youth-onset type one diabetes,” he added, explaining that while the new drug will not replace insulin therapy, it will improve the control of blood sugar for the patient.

“Lots of patients with type one diabetes are struggling to achieve the proper levels of control without suffering all the side effects that come with it. The idea of this new tablet is to improve the levels and to make it easier to control blood sugar and maybe in future use less insulin,” he said.

There are also two other products now under development for type two diabetes patients. Both are based on an already existing product called GLP-1 therapy that is used once a day and is highly effective. It is now hoped that it can soon be used once weekly.

Jensen said that researchers had started the third phase of the drug’s development this year, in order to make it a once weekly injection for patients. “It is a very effective therapy because it works with a very smart technique,” Jensen asserted, explaining that it enables the body to retain normal levels of sugar in the blood.

The second therapy, he went on, “is a little bit more in the open because we are studying how to develop the drug, and this has not been fully decided yet. What we can see now is that this drug also works on two things at the same time.” He added that the drug works on proteins like GLP-1 and on glucagon, a hormone that increases the metabolism and helps the body burn energy.

“According to our knowledge, studies and data, this new therapy will have a good effect on both diabetes and obesity. Hence, we have to work more to create more data and to work on the longer term to see its effects on patients who have high blood sugar and are obese,” he said.

Jensen added the therapy could be most valuable for diabetics who are overweight because it would have an additional weight-loss benefit in addition to benefits for diabetes. “We can use it for people who are obese but not diabetic as well, and it appears that this drug could be tremendously effective in managing obesity,” he said.

“We are now in the first phase of the development of this drug, and we are working hard to enter the second phase to determine whether it will be only for diabetes patients or obese people or both,” Jensen told the Weekly. He said that after this the company would continue to phase three, the most expensive. “We need to investigate more fully in order to prove the drug is safe and that it will be effective for the majority of patients.”

Type two diabetes is a very complicated disease, he said. Obesity and a sedentary lifestyle are key drivers of diabetes, but they are not the only ones. If people practise sport more and monitor their food and sugar intake, this will not end the disease, but it will reduce the number of patients, he said.

Insulin
Insulin City in Frankfurt

THE “INSULIN CITY

On an industrial estate in a suburb of Frankfurt in Germany is Sanofi’s “Insulin City”, its buildings furnished with state-of-the-art equipment to produce up to one million insulin pens, used in the treatment of diabetes, every day.

Martin Siewert, head of the injectable platform at the city, told the Weekly that the first industrial production of insulin started in the city in 1922, and after 95 years in the field it now supplies insulin to over 100 countries around the world and provides job opportunities for 7,750 people working in the research, development, production, manufacturing and administrative sectors.

“This site represents an investment of more than one billion euros and clearly shows our dedication to diabetes,” Siewert told the Weekly. He added that the facility was part of a hub dedicated to research and development, production and smart technology for diabetes treatments.

The process of manufacturing insulin is complicated and takes place in a series of steps, he said. The first is to fabricate the substances needed, which have to be purified in order to attain their full properties. The insulin is produced in liquid form and then packaged under special conditions. Then comes the third step: the integration of the insulin into pens.

Patients expect high-quality products that are easy to use, accurate and effective in delivering the right dose. This means that proper quality control is vital. “This is expensive, but the patient must obtain very effective products,” he said.

“In addition to our great pharmaceutical achievements, we have managed to maintain and conserve the city’s old industrial red-brick buildings that were constructed in the 1920s, using them as a hub for scientific conferences and seminars. Meanwhile, the modern buildings, where the production of insulin takes place, have been built on the southern side of the campus in order not to disturb the old section,” Siewart said.

*This story was first published in Al-Ahram Weekly  

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