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Early in 2019, the European Medicines Agency (EMA) extended the licence for dapagliflozin 5 mg tablets to include use by people with type 1 diabetes who have a body mass index (BMI) ≥27 kg/m2 when insulin alone does not provide adequate glycaemic control.1 The National Institute of Health and Care Excellence (NICE) subsequently adjudged dapagliflozin to be a cost-effective option for those with type 1 diabetes who require insulin doses of at least 0.5 units/kg of body weight per day.2 Additional requirements from NICE include the need for a structured education programme about diabetic ketoacidosis (DKA), to have treatment started and supervised by a specialist consultant physician and to stop the drug after 6 months if there is not a sustained improvement in glycaemic control.
EMA authorisation for type 1 diabetes was based on two placebo-controlled trials …
Competing interests None declared. Refer to the online supplementary files to view the ICMJE form(s).
Provenance and peer review Commissioned; externally peer reviewed.
Addendum On 12 February 2020, NICE approved ▼sotagliflozin for use with insulin for people with type 1 diabetes with BMI ≥27 kg/m2. The issues raised in this editorial also apply to the use of sotagliflozin.