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Sotagliflozin Sanofi Diabetes Update
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Sanofi Diabetes Update:

People living with type 1 diabetes can achieve greater time in range by adding an adjunct to optimized insulin

October 2, 2018 Berlin, Germany 

People living with type 1 diabetes (T1D) face many challenges managing their blood sugar levels. In fact, approximately 75% of these people don’t reach the recommended average blood sugar target (HbA1c) of <7%.1

Despite their efforts to reach the recommended average blood sugar target of <7%,1 people living with T1D remain susceptible to experiencing periods of high and low blood sugar. And even when their average blood sugar levels are at target, people with T1D can spend up to 9 hours per day outside the normal blood sugar range (3.9-10 mmol/L [70–180 mg/dL]).2

In an effort to further examine how to help people living with T1D spend greater time in range (meaning time spent with sugar levels in normal blood sugar range)1, Sanofi, and its development partner Lexicon Pharmaceuticals, presented an additional analysis,3 alongside 52-week data from the inTandem1 and inTandem2 Phase 3 clinical trials4-7, at the European Association for the Study of Diabetes (EASD) 54th Annual Meeting in Berlin, Germany.

Sotagliflozin, alongside optimized insulin, generates patient benefits beyond HbA1c, for adults living with T1D

Adults with T1D who used continuous glucose monitoring (CGM) while participating in the inTandem1 and inTandem2 trials4-7 spent more time in target range using sotagliflozin (ZynquistaTM*), an investigational oral SGLT-1 and SGLT-2 dual inhibitor, with optimized insulin versus using optimized insulin alone.3

Specifically, patients using sotagliflozin 200mg with optimized insulin spent 1.3 hours more time in range per day compared to those using optimized

insulin alone. Those using sotagliflozin 400mg with optimized insulin achieved close to 3 hours of time in range per day.

“SGLT inhibitors used in combination with insulin have shown clinical benefit for patients with type 1 diabetes, especially around improving glycemic control,” said Professor Thomas Danne, Director of the Department of General Pediatrics and Endocrinology/Diabetology at the Kinderkrankenhaus auf der Bult, Hannover, and the study’s lead author.

Professor Danne continued, “Study participants using sotagliflozin not only experienced greater time in range with reduction of time in hyperglycemic ranges, they also benefited from reduced HbA1c on top of maximum tolerated insulin therapy without increasing hypoglycemia. The study also demonstrated significant reductions in postprandial glucose with sotagliflozin compared to patients using optimized insulin alone. This can most likely be attributed to SGLT-1 inhibition.”

Rachele Berria, Global Vice President, Head of Diabetes Medical Affairs at Sanofi, added, “For people with type 1 diabetes it is critical that they concentrate on more than just their HbA1c, and also consider other important markers, such as time in range (3.9-10 mmol/L [70–180 mg/dL]). At Sanofi, we are committed to helping people understand the broad range of factors that should be considered as they work to effectively manage their diabetes.”

Summary of analysis

278 adults with T1D participating in the previously reported inTandem1 and inTandem2 clinical trials6,7 recorded blood sugar levels using CGM technology for the first 24 weeks of the studies. This sub-study3 evaluated CGM data pooled from patients in both studies: sotagliflozin 400mg with optimized insulin (n=96), sotagliflozin 200mg with optimized insulin (n=89) and optimized insulin only (n=93). 

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