Evaluation of Safety and Efficacy of Glaritus<sup>®</sup> versus Lantus<sup>®</sup> in Combination with Insulin Lispro among Adults with Type 1 Diabetes Mellitus-Phase IV Study

Abstract

Objective: The present study assessed safety and efficacy of Glaritus® among adults with Type 1 Diabetes Mellitus (T1DM). Methodology: This prospective, randomized, multicenter, comparative, non-inferiority, open-label, parallel group, phase IV study was conducted in 14 study centers in India. Subjects were randomly allocated to receive either Glaritus® or Lantus® for 12 weeks. Each week, the dose of insulin was titrated to maintain target fasting blood glucose (FBG) level range of 80 -120 mg/dL. Results: A total of 171 subjects were randomized (Glaritus® arm-86; Lantus® arm-85) and 161 subjects completed the study. The mean change in the glycosylated haemoglobin (HbA1c) levels from visit 3 (baseline) to visit 6 (end of trial) in Glaritus® arm was −0.69 ± 1.81 and in Lantus® arm was −0.53 ± 1.94. The mean change in glucose levels between week 1 and end of week 11 in Glaritus® arm was −8.81 ± 34.57 and in Lantus® arm was −5.28 ± 30. At least one hypoglycemic episode was experienced by 27.2% subjects of Glaritus® arm and 28.6% subjects of Lantus® arm. A total of 24 adverse events (AEs) such as pain, pyrexia, few infection related including urinary tract infections, metabolic related such as decreased appetite, musculoskeletal, neurological and skin related were re-

Immunogenicity, Safety and Efficacy Comparison of Wockhardt’s Biosimilar Insulin Glargine—Glaritus® with Reference Product— Lantus®: Study Protocol & Early Data Trends

“…In phase IV study in 161 type 1 diabetics, Glaritus® was found comparable to Lantus® in terms of glycemic control (mean reduction in HbA1c from baseline 0.69% ± 1.81% vs. 0.53% ± 1.94%, respectively; P = 0.454), incidence of hypoglycaemia (27.2% vs. 28.6%, P = 0.8432) and immunogenicity (mean reduction in AIA from baseline 0.25 ± 0.97 vs. 0.02 ± 0.68, respectively; P = 0.306) over 12 weeks of treatment [31]. Open Journal of Endocrine and Metabolic Diseases…”

Future Prospects of Insulin Mutants, Biosimilars, Bioconjugates, and Newer Insulin-Delivery Devices in Diabetes Mellitus

“…Glaritus® and Lantus are bioequivalent, according to research involving healthy volunteers. 26 In a 12-week trial of adult patients with T1DM, Glaritus®, a biosimilar insulin glargine, was found to have glycemic control that was on par with Lantus®. 27,28…”