A5059101355- Blood groups and transfusion
- Diabetes Management and Research
- Diabetes Treatment and Management
- Erythrocyte Function and Pathophysiology
- Pancreatic function and diabetes
- Chronic Lymphocytic Leukemia Research
- Platelet Disorders and Treatments
- Immunodeficiency and Autoimmune Disorders
- Diabetes and associated disorders
- Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Hemoglobinopathies and Related Disorders
- Blood disorders and treatments
- Metabolism, Diabetes, and Cancer
- Complement system in diseases
- Hematological disorders and diagnostics
- Human Health and Disease
- Birth, Development, and Health
- Parvovirus B19 Infection Studies
- Pharmacology and Obesity Treatment
- Diabetes Management and Education
- Chronic Disease Management Strategies
- Biosimilars and Bioanalytical Methods
- Metabolism and Genetic Disorders
- Cardiovascular and Diving-Related Complications
- Medical and Biological Sciences
Sanofi (United States)
2024
Sanofi (France)
2012-2021
Institute of Philosophy and Sociology
2016-2020
Oregon Medical Research Center
2014
OBJECTIVE To compare the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with 100 (Gla-100) in people type 2 diabetes using basal (≥42 units/day) plus oral antihyperglycemic drugs (OADs). RESEARCH DESIGN AND METHODS EDITION was a multicenter, open-label, two-arm study. Adults receiving OADs were randomized to Gla-300 or Gla-100 once daily for 6 months. The primary end point change HbA1c. main secondary percentage participants one more nocturnal confirmed (≤3.9 mmol/L [≤70...
Sutimlimab, a first-in-class humanized immunoglobulin G4 (IgG4) monoclonal antibody that selectively inhibits the classical complement pathway at C1s, rapidly halted hemolysis in single-arm CARDINAL study recently transfused patients with cold agglutinin disease (CAD). CADENZA was 26-week randomized, placebo-controlled phase 3 to assess safety and efficacy of sutimlimab CAD without recent (within 6 months prior enrollment) transfusion history. Forty-two screening hemoglobin ≤10 g/dL,...
OBJECTIVE To provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled insulin glargine or without 1–3 oral antidiabetic agents (OADs). RESEARCH DESIGN AND METHODS Patients were randomized lixisenatide once daily glulisine given thrice daily, added glargine, metformin, if HbA1c remained ≥7 ≤9% (≥53 ≤75 mmol/mol) after 12 weeks of optimization OADs other than metformin...
Aims To compare the efficacy and safety of new insulin glargine 300 U/ml ( Gla ‐300) with 100 ‐100) over 12 months treatment in people type 2 diabetes using basal oral antihyperglycaemic drugs OADs ). Methods EDITION NCT01499095 ) was a randomized, 6‐month, multicentre, open‐label, two‐arm, phase IIIa study investigating once‐daily ‐300 versus ‐100, plus (excluding sulphonylureas), 6‐month extension. Results Similar numbers participants each group completed [ ‐300, 315 (78%); 314 (77%)]. The...
Abstract Cold agglutinin disease (CAD) is a rare, autoimmune, classical complement pathway (CP)‐mediated hemolytic anemia. Sutimlimab selectively inhibits C1s of the C1 complex, preventing CP activation while leaving alternative and lectin pathways intact. In Part A (26 weeks) open‐label, single‐arm, Phase 3 CARDINAL study in patients with CAD recent history transfusion, sutimlimab demonstrated rapid effects on hemolysis Results B (2‐year extension) study, described herein, that sustains...
Insulin glargine 300 U/mL (Gla-300) has a more constant and prolonged action profile than insulin 100 in clinical studies is associated with similar glycemic control but less hypoglycemia. Whether its effects are altered by variability of injection time was examined two 3-month substudies.Eligible participants completing 6 months optimized treatment Gla-300 EDITION 1 (n = 109) 2 89), having mean hemoglobin A1c (HbA1c) level 7.3 % (SD 1.0 %), were randomized (1:1) to groups advised increase...
To explore if efficacy and safety findings for insulin glargine 300U/mL (Gla-300) versus 100U/mL (Gla-100), observed over 6 months in insulin-naïve people with type 2 diabetes, are maintained after 12 months.EDITION 3 was a phase 3a, randomized, multicentre, open-label, parallel-group, treat-to-target study of once-daily Gla-300 Gla-100 (target fasting self-monitored plasma glucose, 4.4-5.6mmol/L [80-100mg/dL]). Participants completing the initial 6-month treatment continued their previously...
Purpose To validate the use of Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire in cold agglutinin disease (CAD) patients using qualitative and quantitative methods to estimate meaningful within-patient change (MWPC). Methods Qualitative assessment used outcomes from a survey among CAD their caregivers US. Quantitative two Phase-3 trials wherein fatigue was evaluated as key secondary endpoint FACIT-Fatigue questionnaire. The reliability, validity,...
Riliprubart is a second-generation, humanized immunoglobulin G4 that inhibits only the activated form of C1s component proximal classical complement pathway. The clinical studies riliprubart conducted thus far for treatment cold agglutinin disease (CAD), rare autoimmune disease, include Phase 1 first-in-human study in healthy participants and 1b single-dose 12 adult CAD patients. objective this was to derive dosing regimen patients using model-informed drug development (MIDD) approaches...
Cold agglutinin disease is a rare autoimmune hemolytic anemia characterized by complement pathway-mediated hemolysis. Riliprubart (SAR445088, BIVV020), second-generation classical inhibitor, humanized monoclonal antibody that selectively inhibits only the activated form of C1s. This Phase 1b study evaluated safety, tolerability, and effect on hemolysis riliprubart in adult patients with cold disease. On day 1, 12 received single IV dose either 30 mg/kg (n = 6) or 15 were subsequently...
Background: This study compared the efficacy, safety, and immunogenicity of insulin aspart biosimilar/follow-on biologic product SAR341402 (SAR-Asp) with originator aspart-NovoLog®/NovoRapid® (NN-Asp) in people type 1 diabetes (T1D) or 2 (T2D) treated multiple daily injections combination glargine (Lantus®; Gla-100). Materials Methods: 6-month, randomized, open-label, phase 3 (NCT03211858) enrolled 597 T1D (n = 497) T2D 100). Participants were randomized 1:1 to mealtime SAR-Asp 301) NN-Asp...
To compare efficacy and safety of insulin glargine 300 units/mL (Gla-300) 100 (Gla-100) in children adolescents (6-17 years old) with type 1 diabetes.EDITION JUNIOR was a noninferiority, international, open-label, two-arm, parallel-group, phase 3b trial. Participants were randomized 1:1 to Gla-300 or Gla-100, titrated achieve fasting self-monitored plasma glucose levels 90-130 mg/dL (5.0-7.2 mmol/L), continuation prior prandial insulin. The primary end point change HbA1c from baseline week...
Cold agglutinin disease (CAD) is a rare form of autoimmune hemolytic anemia with substantial burden on patient's quality life. CARDINAL was 2-part, open-label, single-arm, multicenter phase 3 study evaluating the C1s inhibitor, sutimlimab, for treatment CAD. Part A consisted pivotal phase, part B extension assessing long-term safety and durability response including patient-reported outcomes, which focus this report. Altogether, 22 patients continued from to B, majority female (68.2%) median...
Cold agglutinin disease (CAD) is a rare chronic autoimmune haemolytic anaemia, driven mainly by classical complement pathway activation, leading to profound fatigue and poor quality of life. In the Phase 3 CADENZA trial, sutimlimab-a C1s inhibitor-rapidly halted haemolysis, increased haemoglobin levels improved versus placebo in patients with CAD without recent history transfusion. Patient-reported outcomes (PROs) included Functional Assessment Chronic Illness Therapy-Fatigue...
SummaryBackgroundCold agglutinin disease (CAD) is a rare autoimmune haemolytic anaemia mediated by the classical complement pathway (CP). Sutimlimab selectively targets C1s inhibiting CP activation. In CADENZA Part A (26-weeks), placebo-controlled study in patients without recent transfusion history, sutimlimab reduced haemolysis, anaemia, and fatigue, was generally well tolerated.MethodsThe (NCT03347422) started March 2018 (Part A) completed December 2021 B). All B were eligible to receive...
Background: SAR341402 (SAR-Asp) is a biosimilar/follow-on of the originator insulin aspart-NovoLog®/NovoRapid® (NN-Asp). This study investigated whether efficacy, safety, and immunogenicity findings for SAR-Asp versus NN-Asp, observed over 6 months in people with type 1 (n = 497) or 2 diabetes 100) treated multiple daily injections combination glargine (Lantus®), are maintained after 12 months. Materials Methods: GEMELLI was multicenter, randomized, open-label, phase 3 study. Participants...