NEWS
New Secondary Analysis of Phase 3 Data Demonstrates Sotagliflozin Improves Time-In-Range (TIR) and Several Parameters of Glucose Control and Variability in Basal Insulin-Treated Type 2 Diabetes
Study results aligned with positive clinical trial outcomes for type 1 diabetes treatment with sotagliflozin
TIR measures approach target set by American Diabetes Association
Data to be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online
THE WOODLANDS, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc.(NASDAQ:LXRX) today announced that data from the SOTA-INS CGM Phase 3 randomized clinical trial demonstrated that once-daily dosing of sotagliflozin 400 mg improved time-in-range (TIR) and several continuous glucose monitoring (CGM) parameters, including glucose variability, in insulin-treated type 2 diabetes (T2D) patients. Researchers also observed positive trends with the once-daily dose of 200 mg. Study findings will be presented September 12th at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online.
The objective of the SOTA-INS CGM study was to evaluate the effect of sotagliflozin on TIR as assessed by CGM in people with T2D. The primary sub-study endpoint was mean change in percentage of time spent within TIR (glucose 70-180 mg/dL [3.9-10.0 mmol/L]) over 24 hours for sotagliflozin 400 mg versus placebo.
The American Diabetes Association recommends a TIR target of at least 70% (17 hours) in people with type 1 diabetes (T1D) or T2D. In this study, sotagliflozin 200 mg and 400 mg once daily TIR (15.3 and 15.9 hours, respectively) approached the ADA target, with modest reductions in time-above-range (TAR) and mild increases in time-below-range (TBR).
Sotagliflozin has previously demonstrated glycemic efficacy and improvements in TIR as an adjunct to insulin therapy in people with T1D who participated in the inTandem clinical trial program.
Details of the data presentation are as follows:
• Effect of Sotagliflozin, a Dual SGLT 1 and 2 Inhibitor, on Continuous Glucose Monitoring in Basal Insulin-Treated Type 2 Diabetes – an ePoster presentation, Thursday, September 12th, 12:45p.m. CEST, IFEMA Madrid, Station 10 and online, presented by Julio Rosenstock, M.D., Senior Scientific Advisor for Velocity Clinical Research, Director of Velocity's site at Medical City Dallas, and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center, Dallas.
TIR measures approach target set by American Diabetes Association
Data to be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online
THE WOODLANDS, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc.(NASDAQ:LXRX) today announced that data from the SOTA-INS CGM Phase 3 randomized clinical trial demonstrated that once-daily dosing of sotagliflozin 400 mg improved time-in-range (TIR) and several continuous glucose monitoring (CGM) parameters, including glucose variability, in insulin-treated type 2 diabetes (T2D) patients. Researchers also observed positive trends with the once-daily dose of 200 mg. Study findings will be presented September 12th at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online.
The objective of the SOTA-INS CGM study was to evaluate the effect of sotagliflozin on TIR as assessed by CGM in people with T2D. The primary sub-study endpoint was mean change in percentage of time spent within TIR (glucose 70-180 mg/dL [3.9-10.0 mmol/L]) over 24 hours for sotagliflozin 400 mg versus placebo.
The American Diabetes Association recommends a TIR target of at least 70% (17 hours) in people with type 1 diabetes (T1D) or T2D. In this study, sotagliflozin 200 mg and 400 mg once daily TIR (15.3 and 15.9 hours, respectively) approached the ADA target, with modest reductions in time-above-range (TAR) and mild increases in time-below-range (TBR).
Sotagliflozin has previously demonstrated glycemic efficacy and improvements in TIR as an adjunct to insulin therapy in people with T1D who participated in the inTandem clinical trial program.
Details of the data presentation are as follows:
• Effect of Sotagliflozin, a Dual SGLT 1 and 2 Inhibitor, on Continuous Glucose Monitoring in Basal Insulin-Treated Type 2 Diabetes – an ePoster presentation, Thursday, September 12th, 12:45p.m. CEST, IFEMA Madrid, Station 10 and online, presented by Julio Rosenstock, M.D., Senior Scientific Advisor for Velocity Clinical Research, Director of Velocity's site at Medical City Dallas, and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center, Dallas.
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