Safety and Efficacy of Biosimilar Insulin Glargine (Basaglar) in Indian Patients with Type 2 Diabetes Mellitus: Results from a Multicenter, Open-Label, Single-Arm, Phase 4 Trial (ABEX).

Article

作者: Arora, Rohit ; Shamanna, Paramesh ; Saboo, Banshi ; Desai, Piyush ; Spaepen, Erik ; Shah, Parag ; Khandelwal, Deepak ; Brahme, Keyur ; Bhattacharya, Indranil

BACKGROUNDBasaglar^®, a biosimilar of glargine, was approved in India for the treatment of diabetes in patients aged >2 years. The efficacy and safety of biosimilar insulin glargine (Basaglar) have been previously established in Phase 3 clinical trials, ELEMENT-1, -2, and -5. This study assessed the safety and efficacy of Basaglar in Indian patients with type 2 diabetes mellitus (T2DM).MATERIALS AND METHODSThis multicenter, open-label, single-arm, phase 4 trial included Indian patients with insulin-naïve T2DM with glycated hemoglobin A1c (HbA1c) ≥7.0 to <11.0% who were receiving ≥2 oral antihyperglycemic drugs and/or a glucagon-like peptide-1-receptor agonist. Patients received Basaglar once daily for 24 weeks, excluding 4 weeks of safety follow-up. The primary endpoint was the incidence of total hypoglycemic events [blood glucose (BG) ≤54 mg/dL (≤3.0 mmol/L)] at week 24.RESULTSOf the 259 patients enrolled, 64.1% were males, had mean [standard deviation (SD)] age 52.1 (11.38) years, and had diabetes for mean (SD) 6.75 (5.16) years. The mean HbA1c (SD) levels significantly improved from baseline to week 24 [-1.03 (1.554); p <0.0001] and Basaglar titration doubled from baseline. Total hypoglycemic events were reported in 10 (3.86%), 7 (2.70%), and 4 (1.54%) patients during weeks 0-24, 0-12, and 12-24, respectively. Ten patients (3.90%) reported 12 adverse events (AE; 11 mild and moderate, one severe). One death, unrelated to Basaglar, was reported.CONCLUSIONBasaglar was well tolerated with few hypoglycemic events and significantly reduced HbA1c and BG from baseline in Indian insulin-naïve patients with T2DM.

2024-05-01·Biologicals

Report of a collaborative study to establish the first Indian Pharmacopoeia reference standard for teriparatide

Article

作者: Singh, Gyanendra Nath ; Jain, Parveen ; Kalaivani, M ; Kumar, Mukesh ; Raghuvanshi, Rajeev Singh ; Jadaun, Gaurav Pratap Singh

A collaborative study was conducted to establish the first Indian Pharmacopoeia Reference Standard (IPRS) for teriparatide to be used in quality control testing of marketed products in compliance with the Indian Pharmacopoeia (IP) monograph. The study objective was to evaluate the candidate standard in terms of the WHO International Standard (IS) to assign its content in mg per vial terms. This study involved four laboratories from India and the candidate standard was calibrated against the WHO IS by each participant laboratory using high-performance liquid chromatography (HPLC) assay method per IP monograph. Direct calibration of the candidate standard resulted in an assigned content of 1.02 mg per vial. Based on the study results the candidate standard was judged suitable to serve as the first IPRS for teriparatide for identification and assay by HPLC.

2022-05-01·Future Oncology4区 · 医学

Efficacy and Safety of First-Line Therapies in EGFR -Mutated Advanced Non-Small-Cell Lung Cancer: A Network Meta-Analysis

4区 · 医学

Review

作者: Nassim, Maria ; Haeussler, Katrin ; Thom, Howard ; Papagiannopoulos, Christos ; Puri, Tarun ; Taipale, Kaisa ; Wang, Xuan ; Traore, Sory ; D'yachkova, Yulia ; Winfree, Katherine B

Aim: To evaluate the comparative efficacy and safety of identified first-line therapies for patients with EGFR mutation-positive (EGFRm+) advanced non-small-cell lung cancer (NSCLC), with a focus on ramucirumab + erlotinib. Methods: In the absence of head-to-head studies, a Bayesian network meta-analysis was conducted using randomized clinical trial data to evaluate first-line systemic therapies with erlotinib/gefitinib as the reference treatment. Results: For progression-free survival, ramucirumab + erlotinib was comparable to osimertinib and dacomitinib in the primary analysis. Conclusion: The analysis showed ramucirumab + erlotinib efficacy to be comparable to best-in-class treatment options for previously untreated patients with EGFRm⁺ advanced NSCLC. Registration information: PROSPERO ID: CRD42020136247.

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