Sotagliflozin Added to Optimized Insulin Therapy Leads to Lower Rates of Clinically Relevant Hypoglycemic Events at Any HbA1c at 52 Weeks in Adults with Type 1 Diabetes.
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ABSTRACT: Background: Hypoglycemia rates usually increase when insulin treatment is intensified to improve glycemic control. We evaluated (post hoc) hypoglycemic rates in adult patients with type 1 diabetes (T1D) on sotagliflozin (a dual sodium-glucose cotransporter [SGLT] 1 and 2 inhibitor) in two phase 3, 52-week clinical trials (inTandem 1 and 2; NCT02384941 and NCT02421510). Materials and Methods: We analyzed rates of documented hypoglycemia (level 1, blood glucose ?54 to <70?mg/dL) and clinically important hypoglycemia (level 2, glucose <54?mg/dL) in a patient-level pooled analysis (n?=?1362) using a negative binomial model adjusted for hemoglobin A1c (HbA1c) at 52 weeks in patients receiving placebo, sotagliflozin 200?mg, and sotagliflozin 400?mg. Results: Rates of level 1 hypoglycemia events per patient-year were 58.25 (95% confidence interval: 50.26-67.50) with placebo, 44.86 (38.83-51.82; P?=?0.0138 vs. placebo) with sotagliflozin 200?mg, and 45.68 (39.52-52.81; P?=?0.0220) with sotagliflozin 400?mg. Sotagliflozin was also associated with lower rates of level 2 hypoglycemia: 15.95 (14.37-17.70), 11.51 (10.39-12.76; P?
PROVIDER: S-EPMC6708262 | BioStudies |
REPOSITORIES: biostudies
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