Abstract
Sodium/glucose cotransporter-2 (SGLT2) inhibitors have not been assessed extensively for the treatment of hyperglycemia in noncritically ill, hospitalized patients with type 2 diabetes (T2D). In this investigator-initiated, treat-to-target, randomized trial, 250 cardiac surgery patients with T2D were randomly assigned (1:1) to receive dapagliflozin 10 mg daily plus basal-bolus insulin (DAPA group) or basal-bolus insulin alone (INSULIN group) in the early postoperative period. The primary outcome was mean differences between groups in their daily blood glucose (BG) concentrations. The major safety outcomes were the occurrence of severe ketonemia/diabetic ketoacidosis (DKA) and hypoglycemia. All analyses were performed according to the intention-to-treat principle. There were no differences in mean daily BG concentrations (149 vs. 150 mg/dL), mean percentage of readings within the target BG of 70-180 mg/dL (82.7% vs. 82.5%), daily total insulin dose (mean, 39 vs. 40 units/day), number of daily insulin injections (median, 3.9 vs. 4), length of stay (median, 10 vs. 10 days), or hospital complications (21.6% vs. 24.8%) between the DAPA and INSULIN groups. Mean plasma ketone levels were significantly higher in the DAPA group than in the INSULIN group at day 3 (0.71 vs. 0.30 mmol/L) and day 5 (0.42 vs. 0.19 mmol/L) of randomization. Six patients in the DAPA group developed severe ketonemia, but none developed DKA. There were no differences in the proportion of patients with BG <70 mg/dL (9.6% vs. 7.2%) between the treatment groups. Numerically fewer patients in the DAPA group developed acute kidney injury (7.2%) than in the insulin group (12.8%). These findings indicate that dapagliflozin complementary to basal-bolus insulin does not improve glycemia further over and above the basal-bolus in hospitalized cardiac surgery patients with T2D. However, dapagliflozin is safe and does not increase the incidence of DKA or other complications during the hospital stay. Disclosure M. S. Kuchay: Other Relationship; Boehringer-Ingelheim, Novartis India, Sanofi, Novo Nordisk, Intas Pharmaceuticals Ltd., Sun Pharmaceutical Industries Ltd., USV Private Limited, MSD Life Science Foundation. C. Kohli: None. G. Bakshi: None. V. Radhika: None. S. Saheer: None. M. K. Singh: None. S. Mishra: Other Relationship; Abbott, Novo Nordisk, Sanofi, AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Intas Pharmaceuticals Ltd., Sun Pharmaceutical Industries Ltd., Merck Sharp & Dohme Corp., Cipla Inc. P. Khatana: None. M. Mishra: None. P. S: None. P. Kaur: Other Relationship; Abbott, AstraZeneca, Boehringer Ingelheim Inc., Eris Lifesciences Ltd., Novartis India, Sanofi. J. S. Wasir: Other Relationship; Abbott, AstraZeneca, Novartis. H. Kaur: Other Relationship; AstraZeneca, Novo Nordisk, Sanofi, Intas Pharmaceuticals Ltd., Sun Pharmaceutical Industries Ltd. A. Singh: None. R. Jain: Other Relationship; Abbott, AstraZeneca, Lilly Diabetes. Funding Diabetes and Endocrinology Foundation of India
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