Sodium- Glucose Cotransporter 2 Inhibition and Glycemic Control in Type 1 Diabetes: Results of an 8-Week Open- Label Proof- ofConcept Trial

OBJECTIVEAdjunctive-to-insulin therapy with sodium-glucose cotransporter 2 (SGLT2) inhibition may improve glycemic control in type 1 diabetes (T1D).RESEARCH DESIGN AND METHODSWe evaluated the glycemic efficacy and safety of empagliflozin 25 mg daily in 40 patients treated for 8 weeks in a single-arm open-label proof-of-concept trial (NCT01392560).RESULTSMean A1C decreased from 8.0 0.9% (64 +/- 10 mmol/mol) to 7.6 +/- 0.9% (60 +/- 10 mmol/mol) (P < 0.0001), fasting glucose from 9.0 +/- 4.3 to 7.0 +/- 3.2 mmol/L (P = 0.008), symptomatic hypoglycemia (<3.0 mmol/L) from 0.12 to 0.04 events per patient per day (P = 0.0004), and daily insulin dose from 54.7 +/- 20.4 to 45.8 +/- 18.8 units/day (P < 0.0001). Mean urinary excretion of glucose increased from 19 +/- 19 to 134 +/- 61 g/day (P < 0.0001). Weight decreased from 72.6 +/- 12.7 to 70.0 +/- 12.3 kg (P < 0.0001), and waist circumference decreased from 82.9 +/- 8.7 to 79.1 +/- 8.0 cm (P < 0.0001).CONCLUSIONSThis proof-of-concept study strongly supports a randomized clinical trial of adjunctive-to-insulin empagliflozin in patients with T1D.