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Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes
Satish K Garg1, Robert R Henry1, Phillip Banks1
1From the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Background:
In most patients with type 1 diabetes, adequate glycemic control is not achieved with insulin therapy alone. We evaluated the safety and efficacy of sotagliflozin, an oral inhibitor of sodium-glucose cotransporters 1 and 2, in combination with insulin treatment in patients with type 1 diabetes.
Methods:
In this phase 3, double-blind trial, which was conducted at 133 centers worldwide, we randomly assigned 1402 patients with type 1 diabetes who were receiving treatment with any insulin therapy (pump or injections) to receive sotagliflozin (400 mg per day) or placebo for 24 weeks. The primary end point was a glycated hemoglobin level lower than 7.0% at week 24, with no episodes of severe hypoglycemia or diabetic ketoacidosis after randomization. Secondary end points included the change from baseline in glycated hemoglobin level, weight, systolic blood pressure, and mean daily bolus dose of insulin.
Results:
A significantly larger proportion of patients in the sotagliflozin group than in the placebo group achieved the primary end point (200 of 699 patients [28.6%] vs. 107 of 703 [15.2%], P<0.001). The least-squares mean change from baseline was significantly greater in the sotagliflozin group than in the placebo group for glycated hemoglobin (difference, -0.46 percentage points), weight (-2.98 kg), systolic blood pressure (-3.5 mm Hg), and mean daily bolus dose of insulin (-2.8 units per day) (P≤0.002 for all comparisons). The rate of severe hypoglycemia was similar in the sotagliflozin group and the placebo group (3.0% [21 patients] and 2.4% [17], respectively). The rate of documented hypoglycemia with a blood glucose level of 55 mg per deciliter (3.1 mmol per liter) or below was significantly lower in the sotagliflozin group than in the placebo group. The rate of diabetic ketoacidosis was higher in the sotagliflozin group than in the placebo group (3.0% [21 patients] and 0.6% [4], respectively).
Conclusions:
Among patients with type 1 diabetes who were receiving insulin, the proportion of patients who achieved a glycated hemoglobin level lower than 7.0% with no severe hypoglycemia or diabetic ketoacidosis was larger in the group that received sotagliflozin than in the placebo group. However, the rate of diabetic ketoacidosis was higher in the sotagliflozin group. (Funded by Lexicon Pharmaceuticals; inTandem3 ClinicalTrials.gov number, NCT02531035 .).
Insights
Sotagliflozin improved glycemic control in type 1 diabetes patients but increased diabetic ketoacidosis risk. This study evaluated sotagliflozin
Area of Science:
- Endocrinology and Metabolism
- Pharmacology and Therapeutics
Background:
- Type 1 diabetes management often requires more than insulin therapy for adequate glycemic control.
- Sotagliflozin, a dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT1/2), was investigated as an adjunct to insulin.
Purpose of the Study:
- To assess the safety and efficacy of sotagliflozin combined with insulin in type 1 diabetes patients.
- To evaluate the impact on glycemic control, weight, blood pressure, and insulin dosage.
Main Methods:
- Phase 3, double-blind, randomized trial involving 1402 patients with type 1 diabetes.
- Participants received either sotagliflozin (400 mg/day) or placebo for 24 weeks, alongside their existing insulin therapy.
- Primary endpoint: glycated hemoglobin (HbA1c) < 7.0% without severe hypoglycemia or diabetic ketoacidosis (DKA).
Main Results:
- A significantly higher proportion of patients on sotagliflozin achieved the primary endpoint (28.6% vs. 15.2%, P<0.001).
- Sotagliflozin led to significant reductions in HbA1c, weight, systolic blood pressure, and daily insulin dose.
- While severe hypoglycemia rates were similar, diabetic ketoacidosis (DKA) occurred more frequently with sotagliflozin (3.0% vs. 0.6%).
Conclusions:
- Sotagliflozin, when added to insulin therapy, improved glycemic control and other metabolic parameters in type 1 diabetes.
- The increased risk of diabetic ketoacidosis (DKA) with sotagliflozin necessitates careful patient selection and monitoring.
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