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Immunosuppressants, rheumatic and gastrointestinal topics
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
Insulin glargine has two additional positive charges in the form of 2 arginine molecules, which alter the isoelectric point of the insulin molecule leading to precipitation in the subcutaneous tissues, thus prolonging absorption [6]. Insulin glargine has onset of action at around 6 hours and has a broad peak of activity lasting approximately 24 hours. Substitution of insulin glargine for isophane insulin has been shown to reduce nocturnal hypoglycaemia in children and adolescents, when used in conjunction with a rapid-acting analogue [7,8].
Diabetes mellitus and the Indo-Asians
Published in Partha Ghosh, Shahid Anis Khan, Transcultural Geriatrics, 2018
Partha Ghosh, Shahid Anis Khan
Patients who do not achieve ideal control on dietary regimen and maximum antidiabetic medications, may have insulin added to oral therapy or substituted for the oral therapy (Box 5.2). Isophane insulin is usually given at bedtime. Weight gain and hypoglycaemia are the usual complications of insulin therapy (Table 5.9).
Section 5
Published in Padmanabhan Ramnarayan, MCQs in Paediatrics for the MRCPCH, Part 1, 2017
Microangiopathic changes causing retinal changes, renal changes, and vascular/neurological changes are rare before the age of puberty, mainly because they take a few years of poorly controlled diabetes to cause problems. Although diabetes can be associated with other autoimmune conditions like Addison's disease and hyperthyroidism, it is not necessarily always true. Lumpy changes from lipody s trophy are common in the areas of injections and are reasons for poor control of diabetes due to poor absorption of the insulin from these sites. Isophane insulin (medium-term action) acts slower compared to plain insulin (quick action).
Perinatal exposure to silver nanoparticles reprograms immunometabolism and promotes pancreatic beta-cell death and kidney damage in mice
Published in Nanotoxicology, 2021
Ratnakar Tiwari, Radha Dutt Singh, Monika Binwal, Anurag Kumar Srivastav, Neha Singh, Hafizurrahman Khan, Siddhartha Gangopadhyay, Nidhi Argaria, Prem Narain Saxena, Somendu Kumar Roy, Mahadeo Kumar, Vineeta Sharma, Vikas Srivastava
To examine the effect of gestational and lactational AgNPs exposure on glucose homeostasis, an Oral Glucose Tolerance Test (OGTT) and intra-peritoneal Insulin tolerance test (ITT) were performed. For OGTT, mice were fasted for 6 h and then baseline (fasting) blood glucose level was measured. Post baseline glucose measurement, animals were given 2 g/kg body weight D-glucose through oral gavage. For ITT, animals were fasted for 6 h and then 1 U/kg body weight huminsulin (biphasic isophane insulin, manufactured by Gland Pharma Limited, Hyderabad, India) diluted in phosphate-buffered saline (PBS, pH 7.4) was given intraperitoneally to animals (200 ± 20 μL per mice, depending upon the weight of animals). Glucose level was measured through Accu-Check Active glucometer at 0, 15, 30, 45, 60, 90, and 120 min after oral glucose administration and intra-peritoneal insulin injection.
Considerations related to comparative clinical studies for biosimilars
Published in Expert Opinion on Drug Safety, 2021
Anurag S. Rathore, James G. Stevenson, Hemlata Chhabra
In 2007, Marvel Lifesciences submitted an application for marketing authorization of biosimilar recombinant human insulin products of three different formulations: soluble rapid-acting insulin (Marvel Rapid), long-acting isophane insulin product (Marvel Long), and 30:70 mixture of these two products (Marvel Mix). The biosimilar insulin products were developed in E. coli bacteria that were transformed by recombinant DNA technology for expressing the insulin gene. The applicant submitted four clinical studies in the biosimilar application that include three PK and PD studies (one study for each formulation) and one efficacy and safety study for all three products. Upon reviewing the submitted application, the EMA’s Committee for Medicinal Products for Human Use (CHMP) raised several concerns in aspects including quality, non-clinical and clinical studies for all the three products [25,26]. On quality aspects, the provided information for manufacturing and purification of drug substance was deficient. Protamine used in formulating the product was not thoroughly characterized and the validation and stability data provided for drug products were also inadequate. The paucity of data was pointed out in repeated dose toxicity, kinetics, and immunogenicity in non-clinical studies. CHMP also identified major objections in the clinical data that led to the disapproval of proposed products.
Pharmacologic treatment options for type 1 diabetes: what’s new?
Published in Expert Review of Clinical Pharmacology, 2019
Laura M. Nally, Jennifer L. Sherr, Michelle A. Van Name, Anisha D. Patel, William V. Tamborlane
As laboratory methods advanced, scientists were able to modify the chemical structure of insulin to allow it to be absorbed more rapidly [1]. In contrast to regular human insulin, with a duration of action up to 7–8 hours, the more rapid absorption of lispro, aspart and glulisine insulins were better able to mitigate early post-meal peaks in plasma glucose and decrease the risk of late post-prandial hypoglycemia [2]. Moreover, the lower peaks and longer-duration of action of new long-acting basal insulin analogs like glargine and detemir provided a better means to regulate overnight and between meal glucose control. Additionally, exclusive use of rapid-acting insulin analogs in insulin pump therapy allowed clinicians and patients to tailor insulin doses more precisely. In head-to-head comparisons, CSII was able to surpass multiple daily injections (MDI) treatment for T1D over glargine and isophane insulin types [3–5].