Ana Palanca1,2, Falco van Nes3, Felipe Pardo1, F Javier Ampudia Blasco1,2,4, Chantal Mathieu3. 1. Endocrinology and Nutrition Department, University Hospital of Valencia, Valencia, Spain. 2. INCLIVA Biomedical Research Institute, Valencia, Spain. 3. Clinical and Experimental Endocrinology, KU Leuven, Leuven, Belgium. 4. Department of Medicine, Medicine Faculty, University of Valencia, Valencia, Spain.
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.
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.
Authors: Elisabeth B Stougaard; Peter L Kristensen; Urd Kielgast; Henrik U Andersen; Yasmin Hamid; Peter H Gæde; Esben Søndergaard; Gry H Dørflinger; Karen K Fjeldborg; Klavs W Hansen; Henrik H Thomsen; Thuraya M J Al-Imar; Michael Røder; Vikas S Sridhar; David Cherney; Peter Rossing; Frederik Persson Journal: Diab Vasc Dis Res Date: 2022 Sep-Oct Impact factor: 3.541