Daily Sotagliflozin Improves Glycaemic Control in Patients With Type 1 Diabetes

By Chris Berrie

STOCKHOLM, Sweden -- September 21, 2015 -- Daily oral sotagliflozin improves glycaemic control in intensively treated patients with type 1 diabetes, compared with placebo, according to a study presented here on September 17 at the 51st Annual Meeting of the European Association for the Study of Diabetes (EASD).

Sotagliflozin is a dual SGLT1 and SGLT2 inhibitor, inhibiting glucose uptake in the gastrointestinal tract via SGLT1 receptors and glucose re-uptake in the kidney via SGLT2 receptors. Dr. Buse and colleagues felt that it might provide benefit above that of SGLT2 inhibition alone when used as adjunctive therapy to insulin in patients with type 1 diabetes.

For the study, John B. Buse, MD, University of North Carolina School of Medicine, Chapel Hill, North Carolina, and colleagues evaluated 35 patients with type 2 diabetes, with baseline haemoglobin A1C (Hb A1C) levels between 7.0% and 9.0%, treated with insulin pump or multiple daily injection therapy.

The researchers randomised patients to receive either placebo (n = 17) or sotagliflozin 400 mg (n = 18) once daily for 29 days.

Change from baseline in bolus insulin over days 3 to 27 -- the primary endpoint -- was more significant with sotagliflozin compared with placebo (-32.0% vs -6.4%; P = .007).

Compared with placebo, sotagliflozin produced significant change from baseline for Hb A1C (-0.06% vs -0.55%; P = .002) and body weight (0.5 kg vs -1.7 kg; P = .005).

Change from baseline for fasting plasma glucose (39 vs -18.6 mg/dL) and seated systolic blood pressure (-3.9 vs -4.9 mmHg), however, did not reach significance.

Sotagliflozin was not associated with an increase in hypoglycaemia.

Consistent with SGLT1 inhibition, there was a significant increase in postprandial gastrointestinal peptide hormone PYY (-1.8% vs 11.2%; P = .018) and a numerical increase in glucagon-like peptide 1 (-10.3% vs 3.6%). Consistent with SGLT2 inhibition, there was a significant increase in urinary glucose excretion (9.2 vs 29.1 g/3 hours; P = .0254).

Adverse events were generally similar between treatment groups, with the exception of nausea, diabetic ketoacidosis, and creatine phosphokinase elevation.

Overall, compared with placebo, sotagliflozin was associated with increased gastrointestinal disorders (18% vs 50%), renal and urinary disorders (6% vs 13%), and metabolic and nutrition disorders (0% vs 19%).

Funding for this study was provided by Lexicon Pharmaceuticals.

[Presentation title: Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, Improves Glycemic Control in Type 1 Diabetes Mellitus in a Randomized, Placebo-Controlled, Double-Blind Study. Abstract 182]
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