Real-world Evidence of Efficacy and Safety of SGLT2 Inhibitors as Adjunctive Therapy in Adults With Type 1 Diabetes: A European Two-Center Experience

Diabetes Care. 2022 Mar 1;45(3):650-658. doi: 10.2337/dc21-1584.

Abstract

Objective: To evaluate real-world efficacy and safety of sodium-glucose cotransporter 2 inhibitor (SGLT2i) use in combination with insulin in people with type 1 diabetes.

Research design and methods: We conducted a retrospective cohort European two-center study. Data on demographics, HbA1c, weight, insulin use, renal function, and adverse events were collected for 199 adults with type 1 diabetes who initiated a SGLT2i adjunct to insulin. Subgroup analyses were performed to identify who benefited most and who was more at risk for adverse events.

Results: Overall, significant reductions in mean HbA1c (-0.5%), weight (-2.9 kg), and daily insulin (-8.5%) were achieved after 12 months. The greatest reduction in HbA1c was obtained in individuals with baseline HbA1c >8% (-0.7% [64 mmol/mol]). The most weight loss was observed in subjects with BMI >27 kg/m2 (-3.5 kg). Individuals with baseline estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2 showed an increase in eGFR (4.5 mL/min/1.73 m2), whereas those with urinary albumin-to-creatinine ratio (UACR) >15 mg/g showed a decrease in UACR (-16.6 mg/g). Fifty-seven individuals (28.6%) reported adverse events: 45 with genital infections (22.6%), 5 ketosis episodes (2.5%), and 7 diabetic ketoacidosis (DKA) (3.5%). No severe hypoglycemia events were reported.

Conclusions: Our real-world data on SGLT2i showed promising results in reductions in HbA1c, weight, and insulin requirements in type 1 diabetes. Benefits were more pronounced in individuals with higher baseline HbA1c and BMI. DKA remained a major concern, despite educational measures. Further real-life evidence is still required for evaluation of SGLT2i longer-term effects and their impact on reno-cardiovascular outcomes.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Diabetes Mellitus, Type 1* / chemically induced
  • Diabetes Mellitus, Type 1* / drug therapy
  • Diabetic Ketoacidosis* / chemically induced
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Insulin / adverse effects
  • Retrospective Studies
  • Sodium-Glucose Transporter 2 Inhibitors* / therapeutic use

Substances

  • Hypoglycemic Agents
  • Insulin
  • Sodium-Glucose Transporter 2 Inhibitors

Associated data

  • figshare/10.2337/figshare.17378756