A5019573727- Diabetes Treatment and Management
- Diabetes Management and Research
- Advanced Causal Inference Techniques
- Pharmaceutical studies and practices
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- Metabolism, Diabetes, and Cancer
- Platelet Disorders and Treatments
- Pancreatic function and diabetes
- Inflammatory Bowel Disease
- Pharmacology and Obesity Treatment
- Statistical Methods in Clinical Trials
- Autoimmune Bullous Skin Diseases
Sanofi (United States)
2013-2024
To examine the efficacy and safety of adding once-daily glucagon-like peptide-1 receptor agonist (GLP-1RA) lixisenatide to established basal insulin therapy alone or together with metformin, in people type 2 diabetes elevated glycated hemoglobin (HbA1c).We conducted a double-blind, parallel-group, placebo-controlled trial. Patients (n = 495) but inadequate glycemic control were randomized add 20 μg placebo for 24 weeks. Basal dosage was unchanged except limit hypoglycemia. HbA1c reduction...
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...
Trial design Pemphigus is a rare, but life-threatening autoimmune disease requiring long-term treatment that minimizes corticosteroid (CS) exposure while providing consistent control. The phase 2 pemphigus study of oral, reversible, covalent Bruton tyrosine kinase (BTK) inhibitor rilzabrutinib demonstrated rapid and sustained efficacy with well-tolerated safety. Methods Adults (18–80 y) were randomized 1:1 to 400 mg (n=65) or placebo (n=66) twice daily (with CS ≤0.5 mg/kg/d) for 37 weeks in...
The aim of this study is to explore whether administration timing affects glycaemic control by lixisenatide once-daily in type 2 diabetes mellitus (T2DM).A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre T2DM patients inadequately controlled on metformin was conducted. Patients were administered before breakfast or the main meal. primary endpoint change from baseline at week 24 glycated haemoglobin (HbA1c). Other endpoints: changes body weight, fasting plasma...
There are challenges in designing pediatric trials arising from special ethical issues and the relatively small accessible patient population. The application of conventional phase 3 trial designs to pediatrics is not realistic some therapeutic areas. To address this issue, we propose various approaches for that incorporate data available adult studies using James-Stein shrinkage estimation, empirical Bayesian methods. We also apply concept consistency used multi-regional trials. performance...