TY - JOUR
T1 - Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes
AU - Sands, Arthur T.
AU - Zambrowicz, Brian P.
AU - Rosenstock, Julio
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
N1 - Funding Information:
The authors thank Ike Ogbaa for protocol development and medical monitoring, Sangeeta Sawhney for data review and analysis, Paul Tubbs for project management, Ernest Wang for study management, and Kristi Boehm for assistance with manuscript writing, editing, and QC. All parties providing assistance currently are employees of Lexicon Pharmaceuticals, Inc., or were employees at the time the study was conducted (I.O.). The Robert and Janice McNair Foundation, Houston, TX, partly funded this study. R.H. has received grant support from the NIH. B.W.B. has received research and grant support from the Jaeb Center for Health Research. S.K.G. has received speaking/advisory board consulting fees from the National Institute of Diabetes and Digestive and Kidney Diseases and JDRF and has received research grants from the National Institute of Diabetes and Digestive and Kidney Diseases, JDRF, and T1D Exchange.
Publisher Copyright:
© 2015 by the American Diabetes Association.
PY - 2015/7
Y1 - 2015/7
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.
AB - 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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U2 - 10.2337/dc14-2806
DO - 10.2337/dc14-2806
M3 - Article
C2 - 26049551
AN - SCOPUS:84939621365
SN - 1935-5548
VL - 38
SP - 1181
EP - 1188
JO - Diabetes Care
JF - Diabetes Care
IS - 7
ER -
