The National Institute for Health and Care Excellence (NICE) have announced that sanofi-aventis' type 1 diabetes treatment sotagliflozin, brand name Zynquista▼, in combination 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.
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).
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.
You can follow developments on Zynquista by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.
Why NICE 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.
About sotagliflozin (source EMA)
Zynquista is a diabetes medicine used with insulin to treat adults with type 1 diabetes. It is used in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.
In type 1 diabetes, the body does not make enough insulin to control the amount of glucose (sugar) in the blood, resulting in high levels of glucose in the blood.
The active substance in Zynquista, sotagliflozin, blocks the action of two proteins known as glucose transporters (SGLT1 and SGLT2) which are found in the intestine and the kidneys. By blocking SGLT1 in the intestine, sotagliflozin delays the absorption of glucose into the blood after a meal.
In the kidneys, sotagliflozin blocks SGLT2 involved in stopping glucose in the bloodstream from being passed out into the urine. As a result, sotagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Zynquista was first made available in the EU in 2019. It is manufactured by sanofi-aventis.
European Medicines Agency website page for Zynquista
Links available in External Resources
© NICE 
Sotagliflozin with insulin for treating type 1 diabetes. Technology appraisal guidance [TA622]. Published date: 12 February 2020
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
The information provided by NICE was accurate at the time this article was issued.
NICE: Sotagliflozin with insulin for treating type 1 diabetes
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