Sotagliflozin — HCP Abstract

Rationale: As HbA1c levels for Type 1 diabetes (T1D) patients decrease, the risk of hypoglycaemic events occurring increases. The rate of a hypoglycaemic event for T1D to occur is 73.3 episodes per patient-year for those on insulin alone. Additional therapies have been shown to successfully lower HbA1c but are also associated with increased risk of hypoglycaemic events for patients. Sotagliflozin (SGLT inhibitors) delay glucose absorption in the gut while also reducing glucose reabsorption in the kidneys. In combination with insulin, Sotagliflozin improves glucose control without increasing a patient’s risk of a hypoglycaemic event.

Methods: In 2 identical studies in Europe and North America, researchers randomised 1,362 participants 1:1:1 to receive 200mg or 400mg of Sotagliflozin or the placebo in addition to insulin. The study was split into a 24-week double-blind core period, followed by a 28-week double-blind extension period. The study endpoints analysed was the rate of level-1 (54≤ plasma glucose <70 mg/dL), level-2 (plasma glucose <54 mg/dL) and level-3 (loss of consciousness or seizure) hypoglycaemic events.

Results: At 52-weeks, the mean HbA1c level was 7.4% and 7.3% for 200mg and 400mg Sotagliflozin respectively, vs 7.7% in the placebo group. The rate of level-1 events was lower (44.86 and 45.68 per patient-year) in the 200mg and 400mg treatment groups. As was the incidence of level-2 events (11.51 and 11.13 per patient-year) vs 15.95 in the placebo group. 12 and 10 level-3 events occurred in the respective treatment groups vs 28 in the placebo groups.

Discussion: Participants that received Sotagliflozin in addition to insulin had a substantially lower incidence rate of hypoglycaemic events, irrespective of the participant’s HbA1c level. Therefore, results from this clinical study show that clinicians can control HbA1c levels in T1D patients without increasing the risk of hypoglycaemic events.

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Reference:

Danne, Thomas et al. “Sotagliflozin Added To Optimized Insulin Therapy Leads To Lower Rates Of Clinically Relevant Hypoglycemic Events At Any Hba1c At 52 Weeks In Adults With Type 1 Diabetes”. Diabetes Technology & Therapeutics, vol 21, no. 9, 2019, pp. 471–477. Mary Ann Liebert Inc, doi:10.1089/dia.2019.0157. Accessed 10 Aug 2020.