FDA approves first ever oral Semaglutide for blood sugar control in type 2 diabetes

Food and Drug Administration has approved first GLP-1 oral drug Semaglutide for blood sugar control in type 2 diabetes.

The U.S. Food and Drug Administartion has granted approval to semaglutide oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Oral Semaglutide is the first glucagon-like peptide (GLP-1) receptor protein approved non-injectable treatment for use in the U.S.

Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the Food and Drug Administration welcomes the advancement of new therapeutic options that can make it easier to patients to control their condition, said one of the researcher. Before this approval, patients did not have an oral GLP 1 option to treat their type 2 diabetes, and now patients will have a new option for treating type 2 diabetes without injections.

Type 2 diabetes is the most common form of diabetes that develops when pancreas cannot make enough insulin to keep blood sugar at normal levels GLP1 drugs are non-insulin treatments for people with type 2 diabetes. Semaglutide slows digestion, prevents the liver from making too much sugar and helps the pancreas produce more insulin when needed.

The efficacy and safety of oral Semaglutide in reducing blood sugar in patients with type 2 diabetes were studies in 2 placebo-controlled trials that compared it to other GLP 1 injection treatments, including metformin, sulfonylureas ( insulin secretagogues), sodium-glucose co-transporter 2- (SGLT-2) inhibitors, insulins and thaizolidinediones, all in patients with type 2 diabetes.

In the placebo-controlled studies, Rybelsus as a stand-alone therapy resulted in a significant reduction in blood sugar ( HbA1c) compared with placebo, as determined through HBA1c tests, which measure average levels of blood sugar over time. After 26 weeks, 69% of those taking 7 mg once daily and 77% of those taking 14 mg once daily of Rybelsus decreased their HbA1c to lower than 7%, compared with 31 % patients on placebo.

The prescribing information for Rybelsus includes a boxed warning to advise health care professionals and patients about the potential increased risk of thyroid c-cell tumours, and that Rybelsus is not recommended as the 1st choice of medicine for treating diabetes. Patients who have ever had medullary thyroid carcinoma (MTC) or who have a family member who has ever had MTC are advised not to use Rybelsus. Additionally, patients who have ever had an endocrine system condition called multiple endocrine neoplasia syndrome type 2 (mEN 2) are advised not to use. .Rybelsus. Rybelsus is not for use in patients with type 1 diabetes and people with diabetic ketoacidosis.

Rybelsus also has warnings about panreatitis ( inflammation of the pancreas), diabetic retinopathy ( damage to the eye's retina), hypoglycemia ( low blood sugar(, acute kidney injury and hypersensitivity reactions. It is not known whether Rybelsus can be used by patients who have had pancreatitis. The risk of hypoglycemia increased when Rybelsus was used in combination with sulfonylureas or insulin.

Rybelsus should be taken at least 30 minutes before the first food, beverage or other oral medication of the day, with no more than 4 ounces of plain water. Rybelsus slows digestion, so patients should discus other medications they are taking with their health care provider before starting Rybelsus. The most common side effects are nausea diarrhea, vomiting, decreased appetite, indigestion and constipation.

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Indian scientist develops potential non-insulin diabetes drugs

A young Indian scientist has developed a potential non-insulin drug candidate for diabetic patients that can help eliminate the risk of low-blood glucose shock in case of an insulin overdose.

Arnab De, a PhD in Microbiology and Immunology from Columbia University in New York, has developed the non-insulin drug candidate in collaboration with Richard Di Marchi of Indiana
University.

Patients use insulin to keep their sugar levels in check,an overdose of insulin can lead to low blood-glucose (hypoglycemia), which may cause diabetic-coma and be life-threatening. Insulin treatment has also been reported to cause weight-gain that may exacerbate a diabetic condition, De told PTI.

"We find that there is a peptide hormone in the gut called GLP1 that increases the secretion of insulin only when the blood glucose is high. This effectively eliminates the risk of hypoglycemic shock. Another advantage is that GLP1 administration has been found to stimulate weight-loss.The hormone offers the promise of revolutionizing the
treatment of Type II  diabetes and reduce obesity," he said. 

Regarding the clinical trial of the new drug, De said that GLP-1 has an extremely short half-life of two minutes and this instability has impeded its effective use in patients. As per a study published in the journal Peptide Science, De and Di Marchi "envisioned a prodrug of GLP as a means to extend the duration of action" and their research resulted in several range of options for prolonging peptide action to once-a-day and once-a-week formulations.

"Needless to say, this will be very helpful for patients as we might have a formulation that needs to be taken only once a week as opposed to after every meal" De said. Subho Mozumdar, faculty member ,University of Delhi said that the development of a GLP-1 based pro-drug represents a patient-friendly, diabetic therapeutic. "It is a remarkable breakthrough which might also help to defend against obesity and  perhaps against Alzheimer's disease too. There is a huge market for such a therapeutic in India given the growing number of patients," said Mozumdar.

As per estimates by The International Diabetes Federation, around one in five individuals suffer from some form of obesity.These individuals are three times more prone to heart
attacks or stroke and five times more likely to develop adult-onset of diabetes vis-a-vis individuals without the syndrome.

Indiana University Research and Technology Corporation (IURTC) has applied for patents internationally on these pro-drugs in the world-wide market.De has been conferred the prestigious Young Investigator's Award by American Peptide Society."I hope going forward this drug essentially helps people.That is when the years of hard work and research will pay
off," he added.

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