The Università Campus Bio-Medico di Roma it is the only Italian university to have been involved in the phase 3 trial, which involved 133 centers located in 19 countries around the world. The results, just published in the New England Journal of Medicine, were presented at the EASD in Lisbon. The professor Paolo Pozzilli, professor UCBM and one of the principal investigators of the research: “The drug has been shown to be able to lower blood sugar and glycated hemoglobin, reducing the daily dose of insulin needed by patients. This may mean a lower risk of long-term complications." The new tablet, which promises to improve patients' quality of life by erasing sudden changes in their glycemic levels, has also proved effective in avoiding hypoglycemia, stabilizing blood pressure and promoting weight loss. It will be on the market within a year
Rome, 13 September 2017 – 'A little pill is enough and the sugar goes down': this could be the synthesis of the surprising results obtained by the researchers who have led one international multicenter study of sotagliflozin, which is a candidate to become a new and promising anti-diabetes drug. A single tablet, taken orally, was accompanied by the daily and mandatory supplementation of insulin in patients with type 1 diabetes, forced for life to these stings by the premature death of the beta-cells of their pancreas, no longer able to autonomously supply them with this important hormone. The special pill, taken in the morning at breakfast, proved capable of keep blood glucose at bay and to maintain its effectiveness even with a lower insulin intake. A significant datum for the quality of life of chronic patients who often suffer, despite the daily intake of the hormone, from sudden changes in glycemic levels.
The phase 3 clinical trial lasted 24 weeks and they participated in it 1.402 subjects with type 1 diabetes, recruited from 133 research centers located in 19 countries around the world. The results, published in the scientific journal New England Journal of Medicine and just introduced to European Congress on Diabetes (EASD) underway in Lisbon, they see among the major principal investigator involved the professor Paolo Pozzilli, Professor of Endocrinology and Metabolic Diseases at theUniversità Campus Bio-Medico di Roma (UCBM). "The experimentation – explains the teacher – ascertained that this new drug, which belongs to the class of so-called inhibitors of glucose reabsorption at the renal level, allowing its elimination through the urine, it is able to reduce its absorption also in the intestine. The patients who participated in the clinical trial, thanks to the intake of this tablet, recorded a significant rreduction in insulin requirements and a marked improvement in glycated hemoglobin levels, which is an indication of good metabolism control: in particular, the drug was able to lower their blood sugar and keep it stable despite, at the same time, their insulin intake had been reduced". "This – adds Pozzilli – it can mean a lower risk of long-term complications”. Not only that: Sotagliflozin has also proved itself effective in reducing hypoglycemia, promoting weight loss and controlling blood pressure in subjects in which it was elevated.
The mechanism of action of the drug is simple: usually, after an initial renal filtration, glucose (but with it too the sodium, that's why the compress is effective as well to normalize the pressure) comes reabsorbed into the blood and then returns to the circulation, at least until the glycemic level exceeds 180. Beyond this limit, glucose is eliminated from the body in urine and faeces. The Sotagliflozin changes this glycemic 'threshold' for blood sugar reabsorption, bringing it down to 130. When blood sugar reaches this level, the inhibition of the two glucose transporter proteins is triggered, usually one acting in the kidney and the other in the intestine (SGLT1 and SGLT2) bringing it back into circulation. With their deactivation, the body avoids 'recovering' blood sugar, allowing it definitive elimination.
There are around 1 Italians with type 300 diabetes (source: Ministry of Health). In the world I am affected 29 million people, but the phenomenon is growing. The success of the trial therefore represents a potential revolution in the field of treatment of this autoimmune pathology, also called 'juvenile' because it usually affects subjects in childhood or adolescence and is generated by progressive death of their pancreatic beta-cells, which disappearing little by little, leave these subjects without the daily 'ration' of insulin, necessary to dispose of the sugars taken in with food.
The new molecule belongs to one drug family till now only tested for the treatment of type 2 diabetes, what arises as a result of obesity or poor eating habits. The clinical trials on the 'relatives' of Sotagliflozin had recently demonstrated – in particular for two of them, Empagliflozin and Canagliflozin – the ability to reduce mortality in patients with type 2 diabetes by one third for all causes. Also for this reason, the challenge that now opens up for researchers will be that of "experimentally verify whether this molecule, like the 'cousins' validated for type 2 diabetes, it may have similar effects on mortality also in patients with juvenile diabetes”, concludes Pozzilli.
La sugar killer pill will most likely be available on the market within one year.
