التفاصيل البيبلوغرافية
| العنوان: |
Imatinib therapy for patients with recent-onset type 1 diabetes: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial |
| المؤلفون: |
Gitelman, Stephen E, Bundy, Brian N, Ferrannini, Ele, Lim, Noha, Blanchfield, J Lori, DiMeglio, Linda A, Felner, Eric I, Gaglia, Jason L, Gottlieb, Peter A, Long, S Alice, Mari, Andrea, Mirmira, Raghavendra G, Raskin, Philip, Sanda, Srinath, Tsalikian, Eva, Wentworth, John M, Willi, Steven M, Krischer, Jeffrey P, Bluestone, Jeffrey A, Group, Gleevec Trial Study, Barr, Mayalin, Buchanan, Jeanne, Cabbage, Joanne, Coleman, Peter, De La Vega, Monica, Evans-Molina, Carmella, Ferrara, Christine, Healy, Felicity, Higgins, Laurie, Hildinger, Megan, Jenkins, Margaret, Bryant, Nora Kayton, Kinderman, Amanda, Koshy, Nisha, Kost, Brianne, Krishfield, Suzanne, Kucheruk, Olena, Lindsley, Karen, Mantravadi, Manasa, Mesfin, Shelley, Michels, Aaron, Migre, Mary Ellen, Minnock, Pantea, Mohammed-Nur, Elham, Nelson, Jennifer, Nursing, Ashvin, O'Donnell, Ryan, Olivos, Diana, Parker, Melissa, Redl, Leanne, Reed, Nicole, Resnick, Brittany, Sayre, Peter, Serti, Elisavet, Sims, Emily, Smith, Karen, Soppe, Carol, Stuart, Fiona, Szubowicz, Sarah, Tansey, Michel, Terrell, Jennifer, Tersey, Sarah, Torok, Christine, Watson, Kelly, Wesch, Rebecca, Willi, Steven, Woerner, Stephanie |
| المصدر: |
The Lancet Diabetes & Endocrinology, vol 9, iss 8 |
| بيانات النشر: |
eScholarship, University of California |
| سنة النشر: |
2021 |
| المجموعة: |
University of California: eScholarship |
| مصطلحات موضوعية: |
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Prevention, Autoimmune Disease, Clinical Research, Diabetes, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Metabolic and endocrine, Adolescent, Adult, Biomarkers, Blood Glucose, Diabetes Mellitus, Type 1, Double-Blind Method, Female, Follow-Up Studies, Humans, Imatinib Mesylate, Male, Middle Aged, Prognosis, Protein Kinase Inhibitors, Young Adult, Gleevec Trial Study Group, Medical Biochemistry and Metabolomics, Public Health and Health Services |
| جغرافية الموضوع: |
502 - 514 |
| الوصف: |
BackgroundType 1 diabetes results from autoimmune-mediated destruction of β cells. The tyrosine kinase inhibitor imatinib might affect relevant immunological and metabolic pathways, and preclinical studies show that it reverses and prevents diabetes. Our aim was to evaluate the safety and efficacy of imatinib in preserving β-cell function in patients with recent-onset type 1 diabetes.MethodsWe did a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Patients with recent-onset type 1 diabetes (<100 days from diagnosis), aged 18-45 years, positive for at least one type of diabetes-associated autoantibody, and with a peak stimulated C-peptide of greater than 0·2 nmol L-1 on a mixed meal tolerance test (MMTT) were enrolled from nine medical centres in the USA (n=8) and Australia (n=1). Participants were randomly assigned (2:1) to receive either 400 mg imatinib mesylate (4 × 100 mg film-coated tablets per day) or matching placebo for 26 weeks via a computer-generated blocked randomisation scheme stratified by centre. Treatment assignments were masked for all participants and study personnel except pharmacists at each clinical site. The primary endpoint was the difference in the area under the curve (AUC) mean for C-peptide response in the first 2 h of an MMTT at 12 months in the imatinib group versus the placebo group, with use of an ANCOVA model adjusting for sex, baseline age, and baseline C-peptide, with further observation up to 24 months. The primary analysis was by intention to treat (ITT). Safety was assessed in all randomly assigned participants. This study is registered with ClinicalTrials.gov, NCT01781975 (completed).FindingsPatients were screened and enrolled between Feb 12, 2014, and May 19, 2016. 45 patients were assigned to receive imatinib and 22 to receive placebo. After withdrawals, 43 participants in the imatinib group and 21 in the placebo group were included in the primary ITT analysis at 12 months. The study met its primary endpoint: the adjusted mean difference in 2-h ... |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
unknown |
| العلاقة: |
qt2hr6m8qw; https://escholarship.org/uc/item/2hr6m8qwTest |
| الإتاحة: |
https://escholarship.org/uc/item/2hr6m8qwTest |
| حقوق: |
public |
| رقم الانضمام: |
edsbas.2EBDE653 |
| قاعدة البيانات: |
BASE |
