The effects of empagliflozin in patients with type 1 diabetes: Results of a 12-week, double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND

Sodium-glucose cotransporter-2 (SGLT-2) acts as a key element in the reabsorption of glucose in the kidney. Currently, SGLT-2 inhibitors are FDA-approved for the treatment of type 2 diabetes. It is suggested that the mechanism of action may operate in the treatment of type 1 diabetes mellitus (T1DM), as well. This study aimed to evaluate the application of empagliflozin as an adjunctive to insulin in patients with T1D.

METHODS

In this double-blind placebo-controlled randomized clinical study, 60 type 1 diabetic patients were randomly assigned to have either once-daily empagliflozin 10 mg or placebo, as an addition to insulin for 12 weeks. The hemoglobin A1C, fasting blood sugar (FBS), 2-hour post-prandial blood sugar, and anthropometric indices were measured before and after 12 weeks intervention.

RESULTS

After 12 weeks, empagliflozin resulted in significant reductions of hemoglobin A1C -0.18 (95% CI: -0.37, 0.005, P=0.009), FBS -2.60 mg/dL (95% CI: -6.48, 1.28, P=0.035), 2-hour post-prandial blood sugar -22.56 mg/dL (95% CI: -35.15, 8.97, P<0.0001), and total daily insulin dose -7.6 units (95% CI: -12.4, 2.8, P=0.003). Furthermore, empagliflozin reduced body mass index (BMI) by -0.560 kg (95% CI: -0.640, 1.46, P<0.0001). Empagliflozin was well tolerated in the patients. Also, no case of hypoglycemia, genital and urinary infections, or diabetic ketoacidosis (DKA) was reported.

CONCLUSION

The present study supported the use of empagliflozin alongside insulin as a treatment option for individuals with T1D.

TRIAL REGISTRATION: http://www.irct.ir, identifier: irct20130610013612N12, Registration date: 12/9/2022).