Oral type 1 diabetes medication under FDA review in US

An oral type 1 diabetes drug that can be taken alongside insulin is set to be reviewed by the US Food and Drug Administration (FDA).

Sotagliflozin (marketed as Zynquista), made by pharmaceutical companies Sanofi and Lexicon, is a dual SGLT1 and SGLT2 inhibitor. This means this one tablet has two different functions. The SGLT1 inhibitor part of the drug works by delaying the process of glucose being absorbed by the intestines, which helps avoid the blood sugar spike after a meal.

The SGLT2 inhibitor part helps the kidneys work better at excreting the excess sugar in the blood. Zynquista has undergone several clinical trials and results have shown people who took the drug achieved better HbA1c levels without increasing the risk of severe hypoglycemia.

One issue that the FDA will need to consider is the risk of diabetic ketoacidosis (DKA). DKA is a serious condition that requires emergency hospitalisation and can in some cases be fatal. In one trial of sotagliflozin, 3% of participants on the drug developed DKA compared with just 0.6% in the group that took a placebo.

The drugmakers have now asked the FDA to look at the findings with a view to making it available to members of the public.

Zynquista has also showed to help people lose weight and, on average, trial participants lost 2.98 kg compared to those with type 1 diabetes who had not been prescribed the medication. The drug has been developed in response to the growing levels of people with type 1 diabetes developing serious hypoglycemia.

The news comes in the same week that Diabetes.co.uk has unveiled it will soon be launching its Type 1 Program, which aims to help people with type 1 diabetes achieve better blood sugar control with less fear of hypoglycemia.