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Objective: To compare the effect of pre-mixed human insulin with insulin analogue in diabetic control among type-2 Diabetes mellitus patients at tertiary care hospital. Study Design: Comparative cross-sectional study. Place and Duration of Study: Department of Medicine, Pak Emirates Military Hospital, Rawalpindi, Pakistan, from Jun 2021 to Apr 2022. Methodology: Eleven hundred and fifty-six patients with poorly controlled type-2 diabetes on oral hypoglycemic agents requiring insulin were recruited for the study. Patients were divided into two groups via a lottery method. Group-A received the pre-mixed human insulin, while Group-B received the Insulin analogue advised by the consultant endocrinologist or medical specialist according to the requirements based on recent investigations. Diabetes control was compared in both groups at the end of twelve weeks of treatment. Results: Out of 1156 patients with type-2 diabetes mellitus included in the study, 810(70.1%) were male, while 346(29.9%) were female. The mean duration of DM in the study participants was 3.42±4.44 years. At the end of three months, 978(84.6%) patients had good glycemic control, while 178(15.4%) patients had poor glycemic control. Statistical analysis revealed that the type of insulin used to manage these patients had no significant relationship with glycemic control in our study participants (p-value>0.05). Conclusion: No statistically significant difference was observed in the number of patients achieving adequate glycemic control between those using pre-mixed human insulin and those using insulin analogue in our study.

Objectives: INS068 is a novel, soluble, and long-acting insulin analog. In this study, we evaluated the pharmacokinetics and relative bioavailability of two formulations of INS068 in healthy Chinese subjects: a reference formulation packaged in vials and administered via syringe (R), and a test formulation packaged and administered via pen injector (T).Methods: A randomized, open-label, two-period, two-sequence crossover study was conducted with 24 healthy Chinese subjects. Subjects were randomized and administered subcutaneously in the abdomen at 0.4 U/kg of test or reference INS068 injection according to an open crossover design. INS068 concentrations in the serum were measured using LC-MS/MS, and the pharmacokinetic parameters of maximum concentration (Cmax) and area under the concentration-time curve (AUC0–t and AUC0–∞) were used to evaluate relative bioavailability.Results: After a single dose at 0.4 U/kg, the median Tmax of INS068 was 12 h for both formulations, and the mean t1/2 for T and R was 13.0 h and 12.6 h, respectively. The geometric means of Cmax and AUC0–∞ were 3.99 nmol/L and 120 h·nmol/L for the T, and 4.05 nmol/L and 117 h·nmol/L for the R, respectively. The geometric mean ratios of Cmax, AUC0–t and AUC0–∞ of T over R were 98.7% (90% CI: 92.7%–105.2%), 102.6% (90% CI: 100.0%–105.3%) and 102.8% (90% CI: 100.1%–105.5%).Conclusion: The overall PK profile of the two formulations of INS068 injection was comparable in healthy subjects, and the pen injector of INS068 had adequate safety and tolerability, supporting it as a new formulation in a phase III study and bridging PK data from early phase clinical trials.Clinical Trial Registration:clinicaltrials.gov, identifier: NCT05336071

This phase 1 study compared the pharmacokinetic (PK) and glucose pharmacodynamic (PD) characteristics of biosimilar SAR342434 insulin lispro and Japan‐reference Humalog insulin lispro. This was a randomized, double‐blind, 2‐period, crossover study. Thirty‐six healthy Japanese male subjects underwent a 10‐hour euglycemic clamp following a single subcutaneous 0.3‐U/kg dose of SAR342434 or Humalog. Insulin lispro concentration and blood glucose were measured, and the glucose infusion rate (GIR) was adjusted to maintain the target blood glucose level. Primary PK end points were maximum plasma insulin lispro concentration and area under the plasma insulin concentration–time curve (AUC) from time 0 to the last quantifiable concentration. Primary PD end points were area under the GIR–time curve from time 0 to 10 hours and maximum GIR. PK exposure (maximum plasma concentration and AUC from time 0 to the last quantifiable concentration) and PD activity (GIR‐AUC from time 0 to 10 hours and maximum GIR) were similar between treatments. Geometric mean ratios were close to 1, and the corresponding 90% and 95%CIs (PK and PD activity, respectively) were within the 0.80 to 1.25 equivalence range. SAR342434 and Humalog were well tolerated. In healthy Japanese males, SAR342434 and Humalog showed similar PK exposure profiles and PD potency, in support of SAR342434 use as a biosimilar product. [ABSTRACT FROM AUTHOR]

Background: To address the challenges posed by inconsistent detection of analog insulin in commercially available insulin immunoassays, resulting in potential discrepancies in clinical findings and misdiagnosis during the investigation of factitious hypoglycemia., we aimed to evaluate the ability of the Siemens Atellica automated immunoassay to detect insulin analogs compared with LC-MS/MS., Methods: Five insulin analogs were analyzed at 10 ng/mL spiked into serum samples, with recombinant human insulin as positive controls. Insulin and C-peptide assays were performed using Siemens Atellica and LC-MS/MS. Recovery rates were calculated., Results: Siemens Atellica immunoassay demonstrated robust cross-reactivity (92-121%) of insulin analogs. In contrast, glargine was detected by LC-MS/MS but other analogs were not observed (<10% recovery)., Conclusion: Our results indicate that the insulin assay conducted on the Siemens Atellica platform could be used to diagnose factitious hypoglycemia by detecting the specific insulin analogs involved. The findings from our studies indicate the suitability of this method for clinical laboratory use in cases where factitious hypoglycemia is under consideration as a potential diagnosis. Clinicians should take these results into account when interpreting insulin measurements, particularly in instances where insulin analog overdose is suspected., (© 2024. The Author(s).)

Data from the Social Security Administrator for Health (BPJS Kesehatan) in 2014 to 2019 shows that the use of analog insulin (99.5% of DM cases) in Indonesia is higher than that of human insulin. The high use of insulin in the treatment of type 2 DM causes high costs for purchasing insulin. Therefore a policy is needed in the selection and use of insulin in the treatment for type 2 DM patients. This research aimed to evaluate the treatment profile, costs, and clinical outcomes of the use of human and analog insulin in type 2 DM patients in RSUPN Cipto Mangunkusumo. The longitudinal time-series research methods and data collection were conducted retrospectively. The independent variables of the research were human and analog insulin. While the dependent variables were the profile of treatment, direct treatment costs, and clinical outcomes. The research sample consisted of 291 patients, with exclusion samples of 185 patients and inclusion samples of 106 patients. The research showed that the average cost of a 30-day for single human insulin treatment was Rp.637.748.00. while for single analog insulin was Rp792,493.00. The results of the differences test in the cost of single human insulin treatment and single analog insulin show significant differences with a p value = 0.048. Based on the results of the study it can be concluded that there is significant difference in the cost of treatment in single human insulin and single analog insulin. [ABSTRACT FROM AUTHOR]

Objective: To compare the effect of pre-mixed human insulin with insulin analogue in diabetic control among type-2 Diabetes mellitus patients at tertiary care hospital. Study Design: Comparative cross-sectional study. Place and Duration of Study: Department of Medicine, Pak Emirates Military Hospital, Rawalpindi, Pakistan, from Jun 2021 to Apr 2022. Methodology: Eleven hundred and fifty-six patients with poorly controlled type-2 diabetes on oral hypoglycemic agents requiring insulin were recruited for the study. Patients were divided into two groups via a lottery method. Group-A received the pre-mixed human insulin, while Group-B received the Insulin analogue advised by the consultant endocrinologist or medical specialist according to the requirements based on recent investigations. Diabetes control was compared in both groups at the end of twelve weeks of treatment. Results: Out of 1156 patients with type-2 diabetes mellitus included in the study, 810(70.1%) were male, while 346(29.9%) were female. The mean duration of DM in the study participants was 3.42±4.44 years. At the end of three months, 978(84.6%) patients had good glycemic control, while 178(15.4%) patients had poor glycemic control. Statistical analysis revealed that the type of insulin used to manage these patients had no significant relationship with glycemic control in our study participants (p-value>0.05). Conclusion: No statistically significant difference was observed in the number of patients achieving adequate glycemic control between those using pre-mixed human insulin and those using insulin analogue in our study. [ABSTRACT FROM AUTHOR]

Objectives: INS068 is a novel, soluble, and long-acting insulin analog. In this study, we evaluated the pharmacokinetics and relative bioavailability of two formulations of INS068 in healthy Chinese subjects: a reference formulation packaged in vials and administered via syringe (R), and a test formulation packaged and administered via pen injector (T). Methods: A randomized, open-label, two-period, two-sequence crossover study was conducted with 24 healthy Chinese subjects. Subjects were randomized and administered subcutaneously in the abdomen at 0.4 U/kg of test or reference INS068 injection according to an open crossover design. INS068 concentrations in the serum were measured using LC-MS/MS, and the pharmacokinetic parameters of maximum concentration (C max ) and area under the concentration-time curve (AUC 0-t and AUC 0-∞ ) were used to evaluate relative bioavailability. Results: After a single dose at 0.4 U/kg, the median T max of INS068 was 12 h for both formulations, and the mean t 1/2 for T and R was 13.0 h and 12.6 h, respectively. The geometric means of C max and AUC 0-∞ were 3.99 nmol/L and 120 h·nmol/L for the T, and 4.05 nmol/L and 117 h·nmol/L for the R, respectively. The geometric mean ratios of C max , AUC 0-t and AUC 0-∞ of T over R were 98.7% (90% CI: 92.7%-105.2%), 102.6% (90% CI: 100.0%-105.3%) and 102.8% (90% CI: 100.1%-105.5%). Conclusion: The overall PK profile of the two formulations of INS068 injection was comparable in healthy subjects, and the pen injector of INS068 had adequate safety and tolerability, supporting it as a new formulation in a phase III study and bridging PK data from early phase clinical trials. Clinical Trial Registration: clinicaltrials.gov, identifier: NCT05336071., Competing Interests: Authors X-HG, KS, and SF were employed by the Jiangsu Hengrui Medicine Co., Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Chen, Zhang, Ye, Gao, Song, Zhou, Li, Zhao, Shi, Yang, Shen, Feng and Zhao.)

The discovery of insulin by Banting and Best marked 100 years in 2021, and it was a life-saving treatment modality for type II diabetes mellitus (T2DM). Insulin is a natural hormone that has been used extensively in T2DM patients since its discovery. Currently, insulin analogs are also available in different formulations for T2DM management, overcoming the limitations of human insulin with better safety and side effect profiles. The insulin analogs like the rapid-acting analogs (Aspart, lispro, glulisine), the long-acting basal analogs (Glargine, detemir), the ultra-long acting (Insulin degludec), and the premixed insulin analog formulations (75% Neutral protamine lispro, 25% lispro; 50% neutral protamine lispro, 50% lispro; 70% protamine aspart, 30% aspart) have been prepared through genetic engineering while preserving the basic insulin profile. A large number of studies have demonstrated their clinical effects on glycated hemoglobin test (HbA1c) in achieving glycemic control and thereby lowering the microvascular and macrovascular complications of T2DM with less traditional side effects of regular human insulin, mainly the risk of hypoglycemia, postprandial glycemic excursions, and weight gain. This review explores the currently available insulin analogs, their clinical implications, pharmacokinetics (PK), pharmacodynamics (PD), safety profile, and cost-effectiveness. We also discuss the future developments in the management of T2DM, especially the scientific advancements surrounding the novel insulin formulations, including the biosimilar insulin, and the innovative insulin delivery methods, such as oral and inhaled insulin. [ABSTRACT FROM AUTHOR]