Safety and efficacy of GP40071 compared with originator insulin aspart (NovoRapid
            <sup>®</sup>
            Penfill
            <sup>®</sup>
            ) in Type 1 diabetes mellitus

Karonova, Tatiana; Mayorov, Alexander Yur'evich; Magruk, Maxim A; Zyangirova, S. T.; Grigoryeva, Irina V; Khmelnitski, Oleg K; Myshkovets, Anton; Parfenova, Т.М.; Мосикян, А. А.; Drai, Roman V

doi:10.2217/cer-2020-0208

Cited by 5 publications

(2 citation statements)

References 6 publications

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“…Tested drugs would be investigated on diabetes mellitus populations throughout the immunogenicity investigation similarly to previously developed rapid-acting insulin biosimilars. [14][15][16] Insulin glulisine was measured by mathematical correction of total insulin, evaluated by nonspecific ELISA. Corrections were made by Owen's method used in clamp studies.…”

Section: Discussionmentioning

confidence: 99%

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Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure

Koksharova,

Drai,

Noskov

et al. 2024

Clinical Pharm in Drug Dev

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The aim of the study was to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of T‐glu (GP40321, test drug), and reference insulin glulisine in a hyperinsulinemic‐euglycemic clamp procedure. During this study, 34 healthy male volunteers underwent the hyperinsulinemic‐euglycemic clamp procedure following subcutaneous 0.3 U/kg injection of T‐glu or reference insulin glulisine in a randomized, double‐blind, crossover study. Plasma glucose levels were monitored every 5 minutes for 8 hours. Glucose infusion rate adjustment was based on the blood glucose measurements. Evaluation of PD was performed using the glucose infusion rate values, while PK was calculated using insulin concentrations measured via enzyme‐linked immunosorbent assay. The study results showed that the 90% CI for the geometric mean ratios of primary PK and PD of T‐glu and reference insulin glulisine were within 80%‐125% comparability limits, and that the safety profiles were comparable. PK, PD, and safety similarity of T‐glu and reference insulin glulisine was demonstrated.

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Section: Discussionmentioning

confidence: 99%

“…Although healthy subjects are not a target population for insulin glulisine treatment, it does not impact the biosimilarity investigation. Tested drugs would be investigated on diabetes mellitus populations throughout the immunogenicity investigation similarly to previously developed rapid‐acting insulin biosimilars 14–16 …”

Section: Discussionmentioning

confidence: 99%

Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure

Koksharova,

Drai,

Noskov

et al. 2024

Clinical Pharm in Drug Dev

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New Insulins, Biosimilars, and Insulin Therapy

Danne

Heinemann²,

Bolinder

2022

Diabetes Technology & Therapeutics

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Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis

Yang

Tang

et al. 2022

BMC Endocr Disord

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Background To ascertain the efficacy, safety, and immunogenicity from existing evidence via conducting a meta-analysis of randomized controlled trials between biosimilar and originator insulins. Methods The PubMed, Cochrane Library, EMBASE, and ClinicalTrails.gov were searched to identify head-to-head randomized controlled trials (RCTs) that directly compare the efficacy and safety of biosimilar insulin and its originator. Efficacy was assessed by change of HbA1C, fasting plasma glucose (laboratory or self-monitoring of blood glucose (SMBG)), and change all mean of 7 points- or 8 points- SMBG. Safety was assessed by change in proportion hypoglycemia and serious hypoglycemia. The occurrence of anti-insulin antibodies (AIAs) was also evaluated. Results Fourteen RCTs with 6188 patients from different countries were included. Data were pooled using a random-effects model and were expressed as the mean difference (MD), odds ratio (OR), and 95% confidence interval (CI). In efficacy, Insulin biosimilar products showed similar in change of HbA1C at weeks 26 and 52, the MD were 0.03 (95% CI − 0.02 to 0.07, p = 0.28), and 0.05 (95% CI − 0.05 to 0.15, p = 0.36), respectively. The proportion of HbA1C less than 7% at endpoint, the OR were 1.04 (95% CI 0.89 to 1.20, p = 0.64). The change of fasting plasma glucose (laboratory or SMBG) mmol/L in 24–52 weeks and change all mean of 7 points−/8 points- SMBG mmol/L in 24–52 weeks, the MD were 0.02 (95% CI − 0.20 to 0.24, p = 0.87) and − 0.34 (95% CI − 1.35 to 0.67, p = 0.51), respectively. In occurrence of hypoglycemia (≥ 1 events) and severe hypoglycemia, the OR were 0.96 (95% CI 0.85 to 1.09, p = 0.52) and 1.06 (95% CI 0.85 to 1.31, p = 0.62). The AIA was 1.02 (95% CI 0.90 to 1.16, p = 0.76). Analysis stratified by type of diabetes and duration of insulin. There was no significant difference between the biosimilar and their reference group in a different type of diabetes and different duration of insulin. Conclusions Insulin biosimilar showed comparable characteristics with the reference drug in terms of efficacy, safety, immunogenicity, through comprehensive and specific conventional meta-analysis.

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Safety and efficacy of GP40071 compared with originator insulin aspart (NovoRapid ^® Penfill ^® ) in Type 1 diabetes mellitus

Cited by 5 publications

References 6 publications

Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure

Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure

New Insulins, Biosimilars, and Insulin Therapy

Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis

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Safety and efficacy of GP40071 compared with originator insulin aspart (NovoRapid ® Penfill ® ) in Type 1 diabetes mellitus

Cited by 5 publications

References 6 publications

Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure

Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure

New Insulins, Biosimilars, and Insulin Therapy

Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis

Contact Info

Product

Resources

About

Safety and efficacy of GP40071 compared with originator insulin aspart (NovoRapid ^® Penfill ^® ) in Type 1 diabetes mellitus