Generalized allergy due to zinc in insulin treated with zinc-free insulin

Ammar, I. Ben; Ksouri, Habib; Trabelsi, N.; Mellouli, Fethi; Mami, F. Ben; Dakhli, Saber; Achour, A.

doi:10.1007/s00592-010-0230-4

Cited by 16 publications

(10 citation statements)

References 11 publications

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“…The onset of systemic hypersensitivity varied with some patients experiencing an immediate reaction, while others had an onset several weeks after starting BIL. The occurrence of potential systemic hypersensitivity related to BIL in 5 of 3595 (0.14%) patients exposed in the Phase 3 studies is consistent with the rate of 0.1%-2% reported in the published literature for highly purified human recombinant insulin products 49,50.…”

supporting

confidence: 85%

Basal insulin peglispro: Overview of a novel long‐acting insulin with reduced peripheral effect resulting in a hepato‐preferential action

Jacober

Prince

Beals

et al. 2016

Diabetes Obesity Metabolism

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).Basal insulin peglispro (BIL) is a novel basal insulin with a flat, prolonged activity profile. BIL has been demonstrated in a dog model, in healthy men and in patients with type 1 diabetes (T1D) to have significant hepato-preferential action resulting from reduced peripheral activity. In the IMAGINE-Phase 3 clinical trial program, more than 6000 patients were included, of whom 3900 received BIL. Of the 7 pivotal IMAGINE trials, 3 studies were double-blinded and 3 were in T1D patients. BIL consistently demonstrated a greater HbA1c reduction, less glycaemic variability and a clinically relevant reduction in the rates of nocturnal hypoglycaemia across comparator [glargine and isophane insulin (NPH)] studies. Trials using basal/bolus regimens had higher rates of total hypoglycaemia with BIL due to higher rates of daytime hypoglycaemia.Severe hypoglycaemia rates were similar to comparator among both patients with T1D or type 2 diabetes (T2D). T1D patients lost weight compared with glargine (GL). Patients with T2D tended to gain less weight with BIL than with glargine. Compared to glargine, BIL was associated with higher liver fat, triglycerides and alanine aminotransferase (ALT) levels, including a higher frequency of elevation of ALT ≥3 times the upper limit of normal, but without severe, acute drug-induced liver injury. Injection site reactions, primarily lipohypertrophy, were more frequent with BIL. In conclusion, BIL demonstrated better glycaemic control with reduced glucose variability and nocturnal hypoglycaemia but higher triglycerides, ALT and liver fat relative to conventional comparator insulin. The hepato-preferential action of BIL with reduced peripheral activity may account for these findings. K E Y W O R D Sbasal insulin, drug development, drug mechanism, hypoglycaemia, insulin therapy Insulin therapy has long been a mainstay of therapy for type 1 and

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supporting

confidence: 85%

Basal insulin peglispro: Overview of a novel long‐acting insulin with reduced peripheral effect resulting in a hepato‐preferential action

Jacober

Prince

Beals

et al. 2016

Diabetes Obesity Metabolism

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“…Insulin is not manufactured in Japan, and it is not possible to order the additives for each insulin formulation separately. There have been reports that, in the case of patients with zinc allergies, the allergic symptoms cease when the formulation is switched to one that does not contain zinc, such as human insulin or insulin glulisine [2]. However, in the intradermal tests with the present patient, the result was positive even when humulin ® R which does not contain zinc as an additive was used, and a relationship between zinc and the allergic reaction could therefore be ruled out.…”

Section: Discussionmentioning

confidence: 62%

A case of type 1 diabetes mellitus with which localized insulin allergy was markedly alleviated by switching to insulin glulisine

et al. 2016

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“…Zinc-free insulin was found to be devoid of allergies. 31,32 Phenolic excipients like phenol and meta-cresol can also induce the allergies. Recently, an allergic reaction to metacresol was reported in a 12-year old girl with type 1 diabetes.…”

Section: Insulin Formulations and Their Excipientsmentioning

confidence: 99%

Clinical challenges with excipients in insulin formulations and role of concentrated insulin

Modi

Gadge

Jain³

et al. 2019

Int J Basic Clin Pharmacol

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Most of the insulin formulations in clinical use contain phenol, meta-cresol or both as excipients. These excipients in insulin preparations provide stability and have antimicrobial properties. However, they are reported to be associated with undesirable side-effects especially localised allergic reactions. Amount of excipients injected per unit dose of insulin is a major determining factor in causation of these reactions. This review discusses the excipients in different insulin formulations available in India with potential of precipitating undesirable effects and the use of concentrated insulins to reduce these complications. To avoid the detrimental effects associated with excipients, removal of preservatives or use of insulin preparations devoid of excipients can be an option. Besides these approaches, one approach that can be considered is the use of concentrated insulin to reduce the volume of insulin dose and thereby the excipients. Concentrated insulins address the high insulin requirements of the growing population of patients with type 2 diabetes who require higher insulin doses. Concentrated insulins help in reduction of dose volume as well as amount of excipients injected per unit dose of insulin. U200 (concentrated r-DNA Human Insulin Premix 30/70-200 IU/ml) can be advantageous with better absorption from smaller quantity injected, lesser variability in absorption, lesser pain and discomfort due to smaller quantity, lesser chances of hypoglycaemia all of which can lead to better patient compliance. Thus, concentrated insulin U200 can be one of the alternatives to prevent/reduce clinical complications with excipients in insulins.

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Generalized allergy due to zinc in insulin treated with zinc-free insulin

Cited by 16 publications

References 11 publications

Basal insulin peglispro: Overview of a novel long‐acting insulin with reduced peripheral effect resulting in a hepato‐preferential action

Basal insulin peglispro: Overview of a novel long‐acting insulin with reduced peripheral effect resulting in a hepato‐preferential action

A case of type 1 diabetes mellitus with which localized insulin allergy was markedly alleviated by switching to insulin glulisine

Clinical challenges with excipients in insulin formulations and role of concentrated insulin

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