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).

• Tác giả: Rohit Arora, Indranil Bhattacharya, Keyur Brahme, Piyush Desai, Deepak Khandelwal, Banshi Saboo, Parag Shah, Paramesh Shamanna, Erik Spaepen
• Ngôn ngữ: eng
• Ký hiệu phân loại: 025.523 Cooperative information services
• Thông tin xuất bản: India : The Journal of the Association of Physicians of India , 2025
• Bộ sưu tập: NCBI
• ID: 5103

Tóm tắt

 BACKGROUND: Basaglar MATERIALS AND METHODS: This 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. RESULTS: Of 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)
  CONCLUSION: Basaglar was well tolerated with few hypoglycemic events and significantly reduced HbA1c and BG from baseline in Indian insulin-naïve patients with T2DM.