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10 results on '"Vishweswaramurthy, Ashwini"'

1. Efficacy and safety of Tregopil, a novel, ultra-rapid acting oral prandial insulin analog, as part of a basal-bolus regimen in type 2 diabetes: a randomized, active-controlled phase 2/3 study

Author

Lebovitz, Harold E, primary, Fleming, Alexander, additional, Cherrington, Alan D, additional, Joshi, Shashank, additional, Athalye, Sandeep N, additional, Loganathan, Subramanian, additional, Vishweswaramurthy, Ashwini, additional, Panda, Jayanti, additional, and Marwah, Ashwani, additional

Published
2022
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2. Efficacy and Safety of Tregopil, a Novel, Ultra-Rapid Acting Oral Prandial Insulin Analog, as Part of a Basal-Bolus Regimen in Type 2 Diabetes: A Randomized, Active Controlled Phase 3 Study

Author

Lebovitz, Harold E, primary, Fleming, Alexander, additional, Cherrington, Alan D, additional, Joshi, Shashank, additional, Athalye, Sandeep N., additional, Loganathan, Subramanian, additional, Vishweswaramurthy, Ashwini, additional, Panda, Jayanti, additional, and Marwah, Ashwani, additional

Published
2022
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3. sj-docx-1-tam-10.1177_17588359211045845 ��� Supplemental material for Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer

Author

Socinski, Mark A., Waller, Cornelius F., Idris, Tazeen, Bondarenko, Igor, Luft, Alexander, Beckmann, Katrin, Vishweswaramurthy, Ashwini, Loganathan, Subramanian, Donnelly, Charles, Hummel, Matthew A., Shapiro, Roxann, Woods, Melody, Rao, Anita, Nayak, Vivek G, Ranganna, Gopinath, and Barve, Abhijit

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-docx-1-tam-10.1177_17588359211045845 for Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer by Mark A. Socinski, Cornelius F. Waller, Tazeen Idris, Igor Bondarenko, Alexander Luft, Katrin Beckmann, Ashwini Vishweswaramurthy, Subramanian Loganathan, Charles Donnelly, Matthew A. Hummel, Roxann Shapiro, Melody Woods, Anita Rao, Vivek G Nayak, Gopinath Ranganna and Abhijit Barve in Therapeutic Advances in Medical Oncology

Published
2021
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4. Population pharmacokinetics (Pop PK) of MYL-1402O (a proposed biosimilar to bevacizumab) and reference product (Avastin) in patients with nonsquamous non-small cell lung cancer (nsNSCLC).

Author

Owen, Joel, primary, Rackley, Russell J., additional, Hummel, Matthew A., additional, Roepcke, Stefan, additional, Huang, Hannah, additional, Liu, Mark S., additional, Idris, Tazeen A., additional, Nainar Murugesan, Sundara Moorthi, additional, Vishweswaramurthy, Ashwini, additional, Loganathan, Subramanian, additional, Ranganna, Gopinath, additional, Barve, Abhijit J., additional, Waller, Cornelius, additional, and Socinski, Mark A., additional

Published
2021
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5. Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer

Author

Socinski, Mark A., primary, Waller, Cornelius F., additional, Idris, Tazeen, additional, Bondarenko, Igor, additional, Luft, Alexander, additional, Beckmann, Katrin, additional, Vishweswaramurthy, Ashwini, additional, Loganathan, Subramanian, additional, Donnelly, Charles, additional, Hummel, Matthew A., additional, Shapiro, Roxann, additional, Woods, Melody, additional, Rao, Anita, additional, Nayak, Vivek G, additional, Ranganna, Gopinath, additional, and Barve, Abhijit, additional

Published
2021
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10. Pharmacokinetics and Pharmacodynamics of Insulin Tregopil in Relation to Premeal Dosing Time, Between Meal Interval, and Meal Composition in Patients With Type 2 Diabetes Mellitus.

Author

Khedkar, Anand, Lebovitz, Harold, Fleming, Alexander, Cherrington, Alan, Jose, Vinu, Athalye, Sandeep N., and Vishweswaramurthy, Ashwini

Subjects
TYPE 2 diabetes, INSULIN, PHARMACODYNAMICS, PHARMACOKINETICS
Abstract

We evaluated the pharmacokinetics and pharmacodynamics of oral insulin tregopil in relation to premeal dosing time, between‐meal interval, and meal composition type in type 2 diabetes mellitus patients in a randomized, placebo‐controlled, crossover study consisting of 3 sequential cohorts. In Cohort 1, insulin tregopil administered 10 to 20 minutes before a meal resulted in optimal postmeal exposure and demonstrated better postprandial glucose‐lowering effect (glucose area under concentration‐time curve [AUC]) compared to the 30‐minute group. In Cohort 2, insulin tregopil pharmacokinetic exposure (plasma AUC) showed a progressive increase through 4, 5, and 6 hours of between‐meal interval. The 6‐hour between‐meal interval resulted in better absorption of insulin tregopil in comparison to 4‐ and 5‐hour intervals. However, no significant differences were observed in pharmacodynamic parameters except for higher glucose AUC0‐180min in the insulin tregopil 4‐hour group during the afternoon meal as compared to the morning meal. In Cohort 3, a high‐fiber meal had the least impact on insulin tregopil absorption and resulted in the highest reduction in plasma glucose levels in the afternoon. A high‐fat meal reduced insulin tregopil absorption in the afternoon meal; however, pharmacodynamic response was not diminished significantly. Insulin tregopil has a rapid onset of action of approximately 10 minutes and, when administered 10 to 20 minutes before a meal, demonstrated up to 13% to 18% reduction in blood glucose levels compared to baseline. A 5‐hour between‐meal interval minimizes the impact of a meal on absorption of subsequent (afternoon) insulin tregopil dose, and the pharmacodynamic response of insulin tregopil is not altered by meal composition. Insulin tregopil was well tolerated in patients with type 2 diabetes mellitus. [ABSTRACT FROM AUTHOR]

Published
2020
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