Use of fast‐acting insulin aspart in insulin pump therapy in clinical practice

Evans, Mark L.; Ceriello, Antonio; Danne, Thomas; Block, Christophe De; DeVries, J. Hans; Lind, Marcus; Mathieu, Chantal; Nørgaard, Kirsten; Renard, Éric; Wilmot, Emma G

doi:10.1111/dom.13798

Cited by 42 publications

(41 citation statements)

References 43 publications

(75 reference statements)

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“…As more advanced insulin pump systems become available, it is possible that the accelerated absorption of faster aspart will be even more important for future insulin application systems, including closed-loop and artificial pancreas systems [71,72]. Still, given the relatively limited clinical experience with the use of faster aspart in pumps, larger-scale clinical trials and/or accumulated real-world experience are needed to fully unravel both the safety profile and the clinical potential of faster aspart in pump use [73].…”

Section: Csiimentioning

confidence: 99%

Fast-Acting Insulin Aspart: A Review of its Pharmacokinetic and Pharmacodynamic Properties and the Clinical Consequences

Heise

2019

Clin Pharmacokinet

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Fast-acting insulin aspart (faster aspart) is insulin aspart (IAsp) with two added excipients, l-arginine and niacinamide, to ensure formulation stability with accelerated initial absorption after subcutaneous administration compared with previously developed rapid-acting insulins. The pharmacokinetic/pharmacodynamic properties of faster aspart have been characterised in clinical pharmacology trials with comparable overall methodology. In subjects with type 1 (T1D) or type 2 (T2D) diabetes, the serum IAsp concentration-time and glucose-lowering effect profiles are left-shifted for faster aspart compared with IAsp. In addition, faster aspart provides earlier onset, doubling of initial exposure, and an up to 2.5-fold increase in initial glucose-lowering effect within 30 min of subcutaneous injection, as well as earlier offset of exposure and effect. Similar results have been shown using continuous subcutaneous insulin infusion (CSII). The improved pharmacological properties of faster aspart versus IAsp are consistent across populations, i.e. in the elderly, children, adolescents and the Japanese. Thus, the faster aspart pharmacological characteristics more closely resemble the mealtime insulin secretion in healthy individuals, giving faster aspart the potential to further improve postprandial glucose control in subjects with diabetes. Indeed, change from baseline in 1-h postprandial glucose increment is in favour of faster aspart versus IAsp when used as basal-bolus or CSII treatment in phase III trials in subjects with T1D or T2D. This review summarises the currently published results from clinical pharmacology trials with faster aspart and discusses the potential clinical benefits of faster aspart compared with previous rapid-acting insulin products. Key PointsDespite the advantages of rapid-acting insulins over regular human insulin with respect to pharmacokinetic/ pharmacodynamic properties, there is still a need for accelerated insulin absorption and action to better mimic mealtime insulin secretion in the healthy state.Faster aspart provides an overall left-shift of the pharmacokinetic/pharmacodynamic profiles resulting in earlier onset, twice as large initial exposure, and up to 2.5-fold greater initial glucose-lowering effect within the first 30 min, as well as earlier offset of exposure and effect compared with insulin aspart.In phase III trials, the better resemblance of faster aspart pharmacological characteristics to healthy endogenous mealtime insulin secretion has been shown to lead to improved postprandial glycaemic control in subjects with diabetes relative to previously developed rapid-acting insulins.

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Section: Csiimentioning

confidence: 99%

Fast-Acting Insulin Aspart: A Review of its Pharmacokinetic and Pharmacodynamic Properties and the Clinical Consequences

Heise

2019

Clin Pharmacokinet

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“…Nocturnal, pre‐meal and 4 h post‐meal (particularly the evening meal) IG levels were higher with faster aspart. It was postulated that the elevated nocturnal IG levels with faster aspart might have been because of suboptimal pump settings for the evening meal bolus, lack of basal insulin compensation because of the shorter bolus insulin action, or suboptimal basal insulin rates at night . Hypoglycaemia within the first hour from meal initiation was increased with faster aspart.…”

Section: Second Generation Rapid‐acting Insulin Analoguesmentioning

confidence: 99%

“…However, the results of the two clinical trials of faster aspart appear to suggest that this analogue is less stable and has a higher occlusion rate of CSII catheters than aspart. The cause of this lower physico‐chemical stability is currently being explored and in view of the uncertainty about a more frequent need to replace the infusion sets and a lack of practical guidance on the optimal use of faster aspart, the current rapid‐acting insulin therapies could probably remain the preferred analogues for use in CSII. Limited data have so far been presented for ultra‐rapid lispro .…”

Section: What Is the Potential Role For The Second‐generation Of Rapimentioning

confidence: 99%

The continuing quest for better subcutaneously administered prandial insulins: a review of recent developments and potential clinical implications

Owens

Bolli

2020

Diabetes Obesity Metabolism

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The class of rapid-acting insulin analogues were introduced more than 20 years ago to control postprandial plasma glucose (PPG) excursions better than unmodified regular human insulin. Insulins, lispro, aspart and glulisine all achieved an earlier onset of action, greater peak effect and shorter duration of action resulting in lower PPG levels and a reduced risk of late postprandial hypoglycaemia. However, the subcutaneous absorption rate of these analogues still fails to match the physiological profile of insulin in the systemic circulation following a meal. Recent reformulations of aspart and lispro have generated a second generation of more rapid-acting insulin analogue candidates, including fast-acting aspart (faster aspart), ultra-rapid lispro and BioChaperone Lispro. These modifications have the potential to mimic physiological prandial insulin secretion better with an even earlier onset of action with improved PPG control, shorter duration of effect and reduced risk of hypoglycaemia. Recent phase 3 trials in type 1 and type 2 diabetes show that faster aspart and ultra-rapid lispro compared with conventional aspart and lispro, achieved fewer PPG excursions with a small increase in post-meal hypoglycaemia but similar or marginally superior glycated haemoglobin levels, and suggest the need for parallel optimization of basal insulin replacement. Phase 1 trials for BioChaperone Lispro are equally encouraging with phase 3 trials yet to be initiated. Comparative analysis of the clinical and pharmacological evidence for these new prandial insulin candidates in the treatment of type 1 and type 2 diabetes is the main focus of this review.

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“…A personal CGM device was used only in 25% of the participants. Thus, due to the faster and shorter profile of action of faster aspart, adjustments in basal rate and meal boluses should be made to increase the potential benefit of faster aspart for people with diabetes (20). Studies using this insulin in a hybrid-closed loop system with automatic adjustment of the basal rate are underway.…”

Section: Commentmentioning

confidence: 99%