المصدر: A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a 52-week Blinded Extension Assessing Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Newly Diagnosed Type 1 Diabetes on Insulin Therapy

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT06111586Test

المصدر: A 12-week Randomized, Controlled Trial to Compare TOUJEO® and TRESIBA® in Terms of Glucose Values in Target Range and Variability During Continuous Glucose Monitoring in Patients With Type 1 Diabetes Mellitus

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT04075513Test

المصدر: Shah VN, Al-Karadsheh A, Barnes C, Mandry J, Nakhle S, Wernicke-Panten K, Kramer D, Schmider W, Pierre S, Teichert L, Rotthaeuser B, Mukherjee B, Bailey TS. Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial. Diabetes Obes Metab. 2024 Feb;26(2):540-547. doi: 10.1111/dom.15341. Epub 2023 Oct 25.
Shah VN, Al-Karadsheh A, Barnes C, Mandry J, Nakhle S, Wernicke-Panten K, Kramer D, Schmider W, Pierre S, Teichert L, Rotthaeuser B, Mukherjee B, Bailey TS. Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial. J Diabetes Sci Technol. 2024 Feb 29:19322968241232709. doi: 10.1177/19322968241232709. Online ahead of print.
Randomized, Open Label, Parallel-group Study Comparing the Pharmacokinetics and Immunogenicity of Alternating Use of SAR341402 and NovoLog® Versus Continuous Use of NovoLog in Participants With Type 1 Diabetes Mellitus Also Using Insulin Glargine

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT03874715Test

المصدر: Thrasher J, Polsky S, Hovsepian L, Nowotny I, Pierre S, Bois De Fer B, Bhargava A, Mukherjee B, Garg SK. Safety and Tolerability of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart (NovoLog) When Used in Insulin Pumps in Adults with Type 1 Diabetes: A Randomized, Open-Label Clinical Trial. Diabetes Technol Ther. 2020 Sep;22(9):666-673. doi: 10.1089/dia.2019.0446. Epub 2020 Jan 28.
Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT03436498Test

المصدر: An Open-label, Randomized, Single-dose, 4-period, 4-sequence Crossover Relative Bioavailability Study Comparing Sotagliflozin Prototypes Tablets With Reference Tablet in Healthy Subjects

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT03310944Test

المصدر: Evaluation of Virtual Versus Traditional Study Conduct in a 6-month, Multicenter, Randomized, Open-label, Two-parallel Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT03260868Test

المصدر: Garg SK, Wernke-Panten K, WardeckM, Kramer D, Delalande F, Franek E, Sadeharju K, Monchamp T, Mukherjee B, Shah VN. Effacy and Safety of sul Aspart Bsar SAR341402 Versus Orator sul Aspart People wh Dbetes Treated for 26 Weeks wh Multle Day jectns Combatn wh sul Glarge: A Randomed Open-Label Trl (GEMELL1). Dbetes Technol Ther. 2020 Feb;22(2):85-95. do 10.1089/d.2019.0382.
Garg SK, Wernke-Panten K, WardeckM, Kramer D, Delalande F, Franek E, Sadeharju K, Monchamp T, Mssec P, Mukherjee B, Shah VN. Safety, munogeny, and Glycem Control of sul Aspart Bsar SAR341402 Versus Orator sul Aspart People wh Dbetes Also Usg sul Glarge: 12-Month Results from the GEMELL1 Trl. Dbetes Technol Ther. 2020 Jul;22(7):516-526. do 10.1089/d.2020.0008. Epub 2020 Mar 31.
Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT03211858Test

المساهمون: Medical Affairs Study Director

المصدر: A Single-center, Randomized, Double-blind, 3-period Cross-over Trial to Compare the Effect of Insulin Glulisine, Insulin Lispro and Unmodified Human Insulin on the Endogenous Glucose Production in Type 1 Diabetic Patients.

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT00297583Test

المصدر: A 24-week, Randomized, Open-label, Parallel Group Multinational Comparison of Lantus® (Insulin Glargine) Given in the Morning as Once-a-day Basal Insulin Versus Neutral Protamine Hagedorn (NPH) Insulin, in Children With Type 1 Diabetes Mellitus Aged at Least 1 Year to Less Than 6 Years

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT00993473Test

المساهمون: Trial Transparency Team

المصدر: Randomized, Double-blind, Euglycemic Glucose Clamp Study of Four Formulations of SAR161271, in Single Doses in Healthy Subjects and Single Ascending Doses in Patients With Type 1 Diabetes Mellitus

الوصول الحر: https://clinicaltrials.gov/ct2/show/NCT01053728Test