Efficacy and safety of GP40021 insulin lispro biphasic compared with Humalog Mix 25 in Type 2 diabetes mellitus patients

Mayorov, Alexandr; Мосикян, А. А.; Alpenidze, Diana N; Макаренко, И. Е.; Orlova, Valeria L.; Lunev, Ivan S; Verbovaya, Maria V; Zinnatulina, Bella R; Khokhlov, A. L.; Drai, Roman V

doi:10.2217/cer-2020-0064

Cited by 4 publications

(5 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In addition, the safety results of Yamada et al and our study in hypoglycemia and severe hypoglycemia are 0.99 (95% CI 0.96 to 1.03) versus 0.96 (95% CI 0.85 to 1.09) and 1.09 (95% CI 0.80 to 1.47) versus 1.06 (95% CI 0.85 to 1.31), respectively. This study includes newly RCTs [ 25 , 28 – 30 ], pooled more comprehensive evidence in both long−/short acting insulin biologics, reports consistent outcomes than the previous study. However, our study grouped the studies with corrections combined with hypoglycemic drugs, and the results of the study were found to be similar (change of HbA1C at weeks 26, the MD were 0.03; 95% CI − 0.02 to 0.07, p = 0.28).…”

Section: Discussionmentioning

confidence: 85%

“…A total of 196 records were screened and 89 full-text articles were assessed for eligibility. Fourteen articles were selected for qualitative review [ 17 – 30 ]. The trial selection procedure is shown in Fig.…”

Section: Resultsmentioning

confidence: 99%

“…The studies involved 6188 participants from more than 5 countries. All the studies reported the outcome of efficacy and safety and eleven of them also reported immunogenicity [ 19 , 20 , 22 – 30 ]. Types of insulin biosimilar were involved, 9 studies investigated the long-acting insulin (insulin glargine), including Basalog (Biocon Ltd., Bangalore, India), LY-IGlar (Lily, IN, USA), MYL-1510D (Mylan INC., IN, USA), MK-1293(Merk, NJ, USA), GP40061 (Geropharm, Russian); 4 studies investigated short-acting (insulin aspart, insulin lispro), such as SAR342434, SAR341401 (Sanofi, Paris, France), GP-Asp (Geropharm, Russia); 1 study investigated pre-mixed insulin biosimilar GP-Lis25 (Geropharm, Russia).…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

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

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 85%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

show abstract

“…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%

“…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

View full text Add to dashboard Cite

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.

show abstract

New Insulins, Biosimilars, and Insulin Therapy

Danne

Heinemann²,

Bolinder

2022

Diabetes Technology & Therapeutics

View full text Add to dashboard Cite

Efficacy and safety of GP40021 insulin lispro biphasic compared with Humalog Mix 25 in Type 2 diabetes mellitus patients

Cited by 4 publications

References 8 publications

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

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

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

New Insulins, Biosimilars, and Insulin Therapy

Contact Info

Product

Resources

About