1232-P: Predictors of ß-Cell Function Changes: Pooled Analysis from Phase 3 Ertugliflozin Studies
| Autor: | Roberto A. Calle, Annaswamy Raji, Misoo C. Ellison, Christian Meyer, Silvina Gallo |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Oncology
medicine.medical_specialty endocrine system diseases business.industry Endocrinology Diabetes and Metabolism Direct effects nutritional and metabolic diseases Mixed meal Placebo Pooled analysis Internal medicine Linear regression Internal Medicine Homeostatic model assessment Medicine Ertugliflozin business Glycemic |
| Zdroj: | Diabetes. 68 |
| ISSN: | 1939-327X 0012-1797 |
| DOI: | 10.2337/db19-1232-p |
| Popis: | Improving glycemic control generally improves β-cell function in T2DM but the predictors for this effect are unclear. SGLT2 inhibitors improve glycemia and have no known direct effects on β-cell function. Therefore, we aimed to identify predictors of β-cell function changes by treatment with the SGLT2 inhibitor ertugliflozin (ERTU). Data of patients (pts) randomized to ERTU (5 or 15 mg) only or placebo (PBO) only from four phase 3 ERTU studies of the VERTIS clinical program were pooled and analyzed. Change from baseline in β-cell function (fasting homeostatic model assessment beta [HOMA-β] and C-peptide Insulinogenic Index [IGI] at 30 min of a mixed meal tolerance test) at Week 26 was assessed, followed by linear regression analyses to examine the relationship between change in β-cell function versus metabolic and demographic characteristics. ERTU compared with PBO improved β-cell function when assessed by the changes from baseline (95% CIs) in HOMA-β (14.7 [12.3,17.1] versus −0.4 [−3.4, 2.5]) but not IGI. Change in HOMA-β correlated negatively and similarly with change in A1C in both groups (ERTU: r=−0.29; PBO: r=−0.36, both P Disclosure S. Gallo: Employee; Self; Pfizer Inc. Stock/Shareholder; Self; Pfizer Inc. A. Raji: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. R.A. Calle: Employee; Self; Pfizer Inc. Stock/Shareholder; Self; Pfizer Inc. M.C. Ellison: Employee; Self; Merck & Co., Inc. C. Meyer: Employee; Self; Merck & Co., Inc. Funding Merck Sharp & Dohme Corp; Pfizer Inc. |
| Databáze: | OpenAIRE |
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