We have evaluated the efficacy of
dapagliflozin in patients with
type 1 diabetes mellitus (DM1) without adequate control. We expected that adding
dapagliflozin to this population on top of their base treatment would lower their HbA1c levels. We conducted a pragmatic, open, 24-week study of treatment with 10 mg of oral
dapagliflozin in patients with DM1 and chronic
hyperglycemia. We evaluated
glycemic control,
lipid profile, weight, and
insulin dose. Safety was assessed by adverse event reporting. Fasting
glucose levels decreased from 176.42 ± 45.33 mg/dL to 139.67 ± 44.42 mg/dL (p = 0.05); although no significant valued was reached, postprandial
glucose showed a decreased tendency from 230.25 ± 52.06 mg/dL to 193.83 ± 45.43 mg/dL (p = 0.08). The
hemoglobin A1C (HbA1C) level decreased from 9.18 ± 1.02 (77 ± 11.1 mmol/mol) to 8.05 ± 1.09 % (64 ± 11.9 mmol/mol) (p = 0.0156); total
cholesterol decreased from 299 ± 12 to 199 ± 7 mg/dL (p = 0.02);
triglycerides decreased from 184 ± 15 to 160 ± 11 mg/dL (p = 0.0002), HDL-C decreased from 40 ± 17 to 42 ± 9 mg/dL (p = 0.54); and
LDL-C decreased from 187 ± 19 to 170 ± 21 mg/dL (p = 0.049). No adverse events were reported. The beneficial effects of
SGLT2 inhibitors on metabolic control and their safety after a 24-week open study demonstrate their potential indication as an adjunctive treatment with
insulin in patients with DM1; however, long-term clinical trials should be considered.