1.1 Sotagliflozin with insulin is recommended as an option for treating type 1 diabetes in adults with a body mass index (BMI) of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, only if:
sotagliflozin is given as one 200 mg tablet daily
they are on insulin doses of 0.5 units/kg of body weight/day or more and
they have completed a structured education programme that is evidence based, quality assured, delivered by trained educators and includes information about diabetic ketoacidosis, such as:
how to recognise its risk factors, signs and symptoms
how and when to monitor blood ketone levels
what actions to take for elevated blood ketones and
treatment is started and supervised by a consultant physician specialising in endocrinology and diabetes treatment, and haemoglobin A1c (HbA1c) levels are assessed after 6 months and regularly after this.
1.2 Stop sotagliflozin if there has not been a sustained improvement in glycaemic control (that is, a fall in HbA1c level of about 0.3% or 3 mmol/mol).
1.3 These recommendations are not intended to affect treatment with sotagliflozin that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Sotagliflozin (one 200 mg tablet daily) is an option for some people who cannot manage their type 1 diabetes with insulin alone.
Evidence from clinical trials run for 1 year in this population shows improvements in blood glucose (HbA1c) and weight loss, and improvements in quality of life, with sotagliflozin plus insulin compared with people on placebo plus insulin. The company assumes that the improvement in HbA1c results in a lower risk of long-term complications over a person's lifetime. It's reasonable to assume some relationship between lowering HbA1c and reducing diabetic complications, and between lowering BMI and improving quality of life.
If sotagliflozin improves HbA1c for only 2 years, and no other physiological factors, the cost-effectiveness estimate for sotagliflozin plus insulin compared with insulin alone is within the range that NICE normally considers an acceptable use of NHS resources. Sotagliflozin with insulin is therefore recommended as an option for type 1 diabetes in adults. Because of the increased risk of diabetic ketoacidosis, sotagliflozin should be stopped if blood glucose control does not improve.