Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes

Arthur T. Sands, Brian P. Zambrowicz, Julio Rosenstock, Pablo Lapuerta, Bruce W. Bode, Satish K. Garg, John B. Buse, Phillip Banks, Rubina Heptulla, Marc Rendell, William T. Cefalu, Paul Strumph

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE: To assess the safety and efficacy of dual sodium-glucose cotransporter (SGLT) 1 and SGLT2 inhibition with sotagliflozin as adjunct therapy to insulin in type 1 diabetes. RESEARCH DESIGN AND METHODS: We treated 33 patients with sotagliflozin, an oral dual SGLT1 and SGLT2 inhibitor, or placebo in a randomized, double-blind trial assessing safety, insulin dose, glycemic control, and other metabolic parameters over 29 days of treatment. RESULTS: In the sotagliflozin-treated group, the percent reduction from baseline in the primary end point of bolus insulin dose was 32.1% (P = 0.007), accompanied by lower mean daily glucose measured by continuous glucose monitoring (CGM) of 148.8 mg/dL (8.3 mmol/L) (P = 0.010) and a reduction of 0.55% (5.9 mmol/mol) (P = 0.002) in HbA1c compared with the placebo group that showed 6.4% reduction in bolus insulin dose, a mean daily glucose of 170.3 mg/dL (9.5 mmol/L), and a decrease of 0.06% (0.65 mmol/mol) in HbA1c. The percentage of time in target glucose range 70-180 mg/dL (3.9-10.0 mmol/L) increased from baseline with sotagliflozin compared with placebo, to 68.2% vs. 54.0% (P = 0.003), while the percentage of time in hyperglycemic range >180 mg/dL (10.0 mmol/L) decreased from baseline, to 25.0% vs. 40.2% (P = 0.002),for sotagliflozin and placebo, respectively. Body weight decreased (1.7 kg) with sotagliflozin compared with a 0.5 kg gain (P = 0.005) in the placebo group. CONCLUSIONS: As adjunct to insulin, dual SGLT1 and SGLT2 inhibition with sotagliflozin improved glycemic control and the CGM profile with bolus insulin dose reduction, weight loss, and no increased hypoglycemia in type 1 diabetes.

Original languageEnglish
Pages (from-to)1181-1188
Number of pages8
JournalDiabetes Care
Volume38
Issue number7
DOIs
StatePublished - Jul 1 2015

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Type 1 Diabetes Mellitus
Insulin
Placebos
Glucose
Therapeutics
Sodium-Glucose Transporter 1
Safety
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Hypoglycemia
Weight Loss
Research Design
Body Weight

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing
  • Medicine(all)

Cite this

Sands, A. T., Zambrowicz, B. P., Rosenstock, J., Lapuerta, P., Bode, B. W., Garg, S. K., ... Strumph, P. (2015). Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes. Diabetes Care, 38(7), 1181-1188. https://doi.org/10.2337/dc14-2806

Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes. / Sands, Arthur T.; Zambrowicz, Brian P.; Rosenstock, Julio; Lapuerta, Pablo; Bode, Bruce W.; Garg, Satish K.; Buse, John B.; Banks, Phillip; Heptulla, Rubina; Rendell, Marc; Cefalu, William T.; Strumph, Paul.

In: Diabetes Care, Vol. 38, No. 7, 01.07.2015, p. 1181-1188.

Research output: Contribution to journalArticle

Sands, AT, Zambrowicz, BP, Rosenstock, J, Lapuerta, P, Bode, BW, Garg, SK, Buse, JB, Banks, P, Heptulla, R, Rendell, M, Cefalu, WT & Strumph, P 2015, 'Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes', Diabetes Care, vol. 38, no. 7, pp. 1181-1188. https://doi.org/10.2337/dc14-2806
Sands AT, Zambrowicz BP, Rosenstock J, Lapuerta P, Bode BW, Garg SK et al. Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes. Diabetes Care. 2015 Jul 1;38(7):1181-1188. https://doi.org/10.2337/dc14-2806
Sands, Arthur T. ; Zambrowicz, Brian P. ; Rosenstock, Julio ; Lapuerta, Pablo ; Bode, Bruce W. ; Garg, Satish K. ; Buse, John B. ; Banks, Phillip ; Heptulla, Rubina ; Rendell, Marc ; Cefalu, William T. ; Strumph, Paul. / Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes. In: Diabetes Care. 2015 ; Vol. 38, No. 7. pp. 1181-1188.
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AU - Lapuerta, Pablo

AU - Bode, Bruce W.

AU - Garg, Satish K.

AU - Buse, John B.

AU - Banks, Phillip

AU - Heptulla, Rubina

AU - Rendell, Marc

AU - Cefalu, William T.

AU - Strumph, Paul

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N2 - OBJECTIVE: To assess the safety and efficacy of dual sodium-glucose cotransporter (SGLT) 1 and SGLT2 inhibition with sotagliflozin as adjunct therapy to insulin in type 1 diabetes. RESEARCH DESIGN AND METHODS: We treated 33 patients with sotagliflozin, an oral dual SGLT1 and SGLT2 inhibitor, or placebo in a randomized, double-blind trial assessing safety, insulin dose, glycemic control, and other metabolic parameters over 29 days of treatment. RESULTS: In the sotagliflozin-treated group, the percent reduction from baseline in the primary end point of bolus insulin dose was 32.1% (P = 0.007), accompanied by lower mean daily glucose measured by continuous glucose monitoring (CGM) of 148.8 mg/dL (8.3 mmol/L) (P = 0.010) and a reduction of 0.55% (5.9 mmol/mol) (P = 0.002) in HbA1c compared with the placebo group that showed 6.4% reduction in bolus insulin dose, a mean daily glucose of 170.3 mg/dL (9.5 mmol/L), and a decrease of 0.06% (0.65 mmol/mol) in HbA1c. The percentage of time in target glucose range 70-180 mg/dL (3.9-10.0 mmol/L) increased from baseline with sotagliflozin compared with placebo, to 68.2% vs. 54.0% (P = 0.003), while the percentage of time in hyperglycemic range >180 mg/dL (10.0 mmol/L) decreased from baseline, to 25.0% vs. 40.2% (P = 0.002),for sotagliflozin and placebo, respectively. Body weight decreased (1.7 kg) with sotagliflozin compared with a 0.5 kg gain (P = 0.005) in the placebo group. CONCLUSIONS: As adjunct to insulin, dual SGLT1 and SGLT2 inhibition with sotagliflozin improved glycemic control and the CGM profile with bolus insulin dose reduction, weight loss, and no increased hypoglycemia in type 1 diabetes.

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