Glucagon receptor antagonist volagidemab in type 1 diabetes: a 12-week, randomized, double-blind, phase 2 trial
| العنوان: | Glucagon receptor antagonist volagidemab in type 1 diabetes: a 12-week, randomized, double-blind, phase 2 trial |
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| المؤلفون: | Jeremy Pettus, Schafer C. Boeder, Mark P. Christiansen, Douglas S. Denham, Timothy S. Bailey, Halis K. Akturk, Leslie J. Klaff, Julio Rosenstock, Mickie H. M. Cheng, Bruce W. Bode, Edgar D. Bautista, Ren Xu, Hai Yan, Dung Thai, Satish K. Garg, Samuel Klein |
| المصدر: | Nature medicine, vol 28, iss 10 Nat Med |
| بيانات النشر: | eScholarship, University of California, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Blood Glucose, Adult, Lipoproteins, Clinical Trials and Supportive Activities, Immunology, Autoimmune Disease, Medical and Health Sciences, Article, General Biochemistry, Genetics and Molecular Biology, Antibodies, LDL, Double-Blind Method, Clinical Research, Receptors, Monoclonal, Diabetes Mellitus, Humans, Insulin, Humanized, Transaminases, Metabolic and endocrine, Glycated Hemoglobin, Blood Glucose Self-Monitoring, Prevention, Diabetes, Evaluation of treatments and therapeutic interventions, General Medicine, Glucagon, Diabetes Mellitus, Type 1, Treatment Outcome, Diabetes Mellitus, Type 2, 5.1 Pharmaceuticals, 6.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Type 1 |
| الوصف: | Hyperglucagonemia contributes to hyperglycemia in patients with type 1 diabetes (T1D); however, novel therapeutics that block glucagon action could improve glycemic control. This phase 2 study evaluated the safety and efficacy of volagidemab, an antagonistic monoclonal glucagon receptor (GCGR) antibody, as an adjunct to insulin therapy in adults with T1D. The primary endpoint was change in daily insulin use at week 12. Secondary endpoints included changes in hemoglobin A1c (HbA1c) at week 13, in average daily blood glucose concentration and time within target range as assessed by continuous blood glucose monitoring (CGM) and seven-point glucose profile at week 12, incidence of hypoglycemic events, the proportion of subjects who achieve HbA1c reduction of ≥0.4%, volagidemab drug concentrations and incidence of anti-drug antibodies. Eligible participants (n = 79) were randomized to receive weekly subcutaneous injections of placebo, 35 mg volagidemab or 70 mg volagidemab. Volagidemab produced a reduction in total daily insulin use at week 12 (35 mg volagidemab: -7.59 units (U) (95% confidence interval (CI) -11.79, -3.39; P = 0.040 versus placebo); 70 mg volagidemab: -6.64 U (95% CI -10.99, -2.29; P = 0.084 versus placebo); placebo: -1.27 U (95% CI -5.4, 2.9)) without meeting the prespecified significance level (P |
| وصف الملف: | application/pdf |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e013b5033dda4927bfaa73b1e637419fTest https://escholarship.org/uc/item/4zh8n26kTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....e013b5033dda4927bfaa73b1e637419f |
| قاعدة البيانات: | OpenAIRE |
| الوصف غير متاح. |