Efficacy and Safety of SGLT2 Inhibitors in Type 1 Diabetes After the Introduction of an Off-Label Use Protocol for Clinical Practice

Abstract

Aims:

We evaluated the real-life efficacy and safety of empagliflozin in combination with optimized insulin therapy in patients with type 1 diabetes (T1D).

Methods:

This was a prospective study, including 27 patients with T1D treated with insulin therapy to whom empagliflozin was added according to an off-label protocol approved for use in clinical practice. The primary end point was the change in HbA_1c 52 weeks after the addition of empagliflozin to insulin therapy. Blood pressure (BP), weight, and safety were also assessed.

Results:

At week 52, the addition of empagliflozin significantly reduced HbA_1c from 8.0% ± 0.7% to 7.2% ± 0.8% (P < 0.001). The mean percentage of time in range for capillary glucose monitoring increased from 50% to 62% (P = 0.008) in parallel to a −0.08 IU/(kg·day) reduction in insulin requirements (P = 0.031). There was also a reduction in the body weight (−8 kg) and in systolic BP from 134 to 127 mmHg (P < 0.001). The most commonly reported adverse events were genitourinary infections (10 episodes in 52 weeks of follow-up). One patient developed an episode of mild diabetic ketoacidosis that motivated empagliflozin withdrawal. No severe hypoglycemic events were registered.

Conclusions:

Our results suggested that the use of empagliflozin following a strict off-label protocol may represent an effective and safe option in real life among patients with T1D, improving metabolic control, and ameliorating some cardiovascular risk factors.