1.1 Dapagliflozin 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:
they are on insulin doses of more than 0.5 units/kg of body weight/day 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.
1.2 Assess haemoglobin A1c (HbA1c) levels after 6 months and regularly after this. Stop dapagliflozin if there has not been a sustained improvement in glycaemic control (that is, a fall in HbA1c level of at least 0.3%).
1.3 These recommendations are not intended to affect treatment with dapagliflozin 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
Evidence from the clinical trials shows small improvements in blood glucose (HbA1c levels) and weight loss, and very small improvements in quality of life, when dapagliflozin plus insulin is compared with placebo plus insulin in adults with type 1 diabetes and inadequate blood glucose control despite optimised insulin therapy. The company extrapolates the effects of the small improvement in HbA1c level with dapagliflozin seen at 1 year in the trials to a lower risk of long-term complications over a patient's lifetime.
In the company's scenario that assumes no benefit from improved HbA1c levels beyond the trial period (1 year), the cost-effectiveness estimate for dapagliflozin plus insulin compared with insulin alone is within the range that NICE normally considers an acceptable use of NHS resources. Dapagliflozin with insulin is therefore recommended as an option for type 1 diabetes in adults. Because of the increased risk of diabetic ketoacidosis, dapagliflozin should be stopped if blood glucose control does not improve.