| Autor: |
Bailey, T.S., Sawhney, S., Rosenstock, J., McGuire, D.K., Buse, J.B., Danne, T., Strumph, P., Garg, S.K., Lapuerta, P., Peters, A.L., Kushner, J.A., Reed, J., Banks, P., Lane, W.S., Bode, B.W. |
| Jazyk: |
angličtina |
| Rok vydání: |
2018 |
| DOI: |
10.17615/88k1-rx27 |
| Popis: |
OBJECTIVE: Evaluate the efficacy and safety of the dual sodium-glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor sotagliflozin in combination with optimized insulin in type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: The in Tandem1 trial, a double-blind, 52-week phase 3 trial, randomized North American adults with T1D to placebo (n = 268), sotagliflozin 200 mg (n = 263), or sotagliflozin 400mg(n =262) after6 weeks ofinsulin optimization. The primary end point was HbA1c change from baseline at 24 weeks. HbA1c, weight, and safety were also assessed through 52 weeks. RESULTS: From a mean baseline of 7.57%, placebo-adjusted HbA1c reductions were 0.36% and 0.41% with sotagliflozin 200 and 400 mg, respectively, at 24 weeks and 0.25% and 0.31% at 52 weeks (all P < 0.001). Among patients with a baseline HbA1c ≥7.0%, an HbA1c |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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