Sotagliflozin: A Review in Type 1 Diabetes
- 57 Downloads
Sotagliflozin (Zynquista™) is the first dual inhibitor of sodium-glucose co-transporter-1 and -2 (SGLT1 and 2). In the phase 3, inTANDEM 1–3 trials, adjunctive use of oral sotagliflozin (200 mg or 400 mg once daily) improved glycaemic control and reduced bodyweight and insulin requirements relative to placebo over 24 weeks of treatment in adults whose type 1 diabetes (T1D) was inadequately controlled by insulin therapy. Similar benefits were seen with the drug in patients who were overweight/obese [i.e. body mass index (BMI) ≥ 27 kg/m2] in inTANDEM 1 and 2 (pooled). The benefits of sotagliflozin were largely maintained over 52 weeks of treatment. Overall, use of sotagliflozin in this setting is generally well tolerated and reduces, or at least does not increase, the likelihood of hypoglycaemia; however, as with other SGLT inhibitors, sotagliflozin carries a risk of diabetic ketoacidosis (DKA). On the basis of its risk/benefit profile, sotagliflozin is indicated in the EU as an adjunct to insulin in adults with T1D with a BMI ≥ 27 kg/m2 who have failed to achieve adequate glycaemic control despite optimal insulin therapy, thus expanding the currently limited adjunctive oral treatment options available for use in this population.
During the peer review process, the marketing authorization holder of sotagliflozin was also offered the opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflicts of interest
Emma Deeks is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
- 2.Mayo Clinic. Type 1 diabetes. 2017. https://www.mayoclinic.org/diseases-conditions/type-1-diabetes/symptoms-causes/syc-20353011. Accessed 14 Nov 2019.
- 4.National Institute for Health and Care Excellence. Type 1 diabetes in adults: diagnosis and management. 2016. https://www.nice.org.uk. Accessed 14 Nov 2019.
- 5.American Diabetes Association. Standards of medical care in diabetes—2019. Abridged for primary care providers. 2019. https://professional.diabetes.org. Accessed 14 Nov 2019.
- 7.European Medicines Agency. Zynquista 200 mg film-coated tablets: summary of product characteristics 2019. https://www.ema.europa.eu/. Accessed 14 Nov 2019.
- 12.Musso G, Gambino R, Cassader M, et al. Efficacy and safety of dual SGLT 1/2 inhibitor sotagliflozin in type 1 diabetes: meta-analysis of randomised controlled trials. BMJ. 2019;365(l1328):1–16.Google Scholar
- 14.van Raalte DH, Bjornstad P, Persson F, et al. The impact of sotagiflozin on renal function, albuminuria, and blood pressure in adults with type 1 diabetes [poster no. 1000]. In: 55th EASD annual meeting. 2019.Google Scholar
- 15.European Medicines Agency. Assessment report: Zynquista (international non-proprietary name: sotagliflozin). 2019. https://www.ema.europa.eu. Accessed 14 Nov 2019.
- 16.Bode B, Banks P, Sawhney S, et al. Efficacy and safety of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct to insulin in young adults with poorly controlled type 1 diabetes (JDRF Study) [abstract no. 186]. Diabetologia. 2017;60(Suppl 1):S87–8.Google Scholar
- 20.Pettus J, Weinzimer SA, McCrimmon RJ, et al. Sotagliflozin in combination with optimized insulin therapy reduced HbA1c levels with a decreased daily insulin requirement after 52 weeks in adults with T1D [abstract no 5-LB]. Diabetes. 2018;67(Suppl 1):LB2.Google Scholar
- 21.Henry R, Rodbard H, Giaccari A, et al. Sotagliflozin further improves percentage of patients achieving HbA1c goal without weight gain in adults with type 1 diabetes after insulin therapy optimisation [abstract no. 614]. Diabetologia. 2018;61(Suppl 1):S297.Google Scholar
- 22.Danne T, Cariou B, Buse JB, et al. Improved time in range and glycemic variability with sotagliflozin in combination with insulin in adults with type 1 diabetes: a pooled analysis of 24-week continuous glucose monitoring data from the inTandem program. Diabetes Care. 2019;42(5):919–30.CrossRefGoogle Scholar
- 23.Kovatchev BP, Wang S, Oliveira J, et al. Sotagliflozin reduces glucose variability and risk for hyperglycaemia in adults with type 1 diabetes [poster no. 717]. In: 55th EASD annual meeting. 2019.Google Scholar
- 24.Sawhney S, Danne T, Ramtoola S, et al. Effect of sotagliflozin on body weight and composition in adults with type 1 diabetes [oral presentation]. In: 55th EASD annual meeting. 2019.Google Scholar
- 26.Joish VN, Danne T, Preblick R, et al. Improved treatment satisfaction in patients with type 1 diabetes treated with sotagliflozin plus insulin versus insulin alone [poster no. 724]. In: 55th EASD annual meeting. 2019.Google Scholar
- 28.Danne T, Frias J, Ampudia-Blasco FJ, et al. Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in overweight and obese patients (BMI ≥ 27 kg/m2) with type 1 diabetes: addressing unmet needs as adjunctive therapy to insulin [oral presentation]. In: 55th EASD annual meeting. 2019.Google Scholar
- 31.National Institute for Health and Care Excellence. Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus. Technology appraisal guidance. 2008. https://www.nice.org.uk. Accessed 14 Nov 2019.
- 32.Garg RK, Vimalananda V. BMJ Best Practice. Type 1 diabetes. 2019. https://bestpractice.bmj.com. Accessed 14 Nov 2019.
- 36.Cefalo CMA, Cinti F, Moffa S, et al. Sotagliflozin, the first dual SGLT inhibitor: current outlook and perspectives. Cardiovasc Diabetol. 2019;18(20):1–14.Google Scholar
- 38.European Medicines Agency. Forxiga 5 mg film-coated tablets: summary of product characteristics. 2019. https://www.ema.europa.eu/. Accessed 14 Nov 2019.
- 39.European Medicines Agency. First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes [media release]. 1 Feb 2019. https://www.ema.europa.eu.