Ultra‐rapid BioChaperone Lispro improves postprandial blood glucose excursions vs insulin lispro in a 14‐day crossover treatment study in people with type 1 diabetes

Andersen, Grit; Meiffren, Grégory; Lamers, Daniela; DeVries, J. Hans; Ranson, Aymeric; Seroussi, Cyril; Alluis, Bertrand; Gaudier, Martin; Soula, Olivier; Heise, Tim

doi:10.1111/dom.13442

Cited by 33 publications

(31 citation statements)

References 3 publications

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“…A new generation of ultra‐fast‐acting insulins, such as BioChaperone Lispro, treprostinil lispro and fast‐acting insulin aspart (faster aspart), is under development. Faster aspart is the first of these to be approved for pump use in adults with T1D and type 2 diabetes (T2D) and it is now available in several countries.…”

Section: Introductionmentioning

confidence: 99%

“…15 Current rapid-acting insulin analogues (RAIAs)insulin aspart (IAsp), insulin lispro and insulin glulisinehave faster absorption kinetics than regular human insulin; 16 however, post-prandial glucose (PPG) control with pump therapy remains limited by the pharmacokinetics of RAIAs. 17 A new generation of ultra-fast-acting insulins, such as BioChaperone Lispro, 18,19 treprostinil lispro 20 and fast-acting insulin aspart (faster aspart), is under development. Faster aspart is the first of these to be approved for pump use in adults with T1D and type 2 diabetes (T2D) and it is now available in several countries.…”

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confidence: 99%

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

Evans

Ceriello

Danne

et al. 2019

Diabetes Obesity Metabolism

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Fast‐acting insulin aspart (faster aspart) is a novel formulation of insulin aspart (IAsp) containing the additional excipients niacinamide and L‐arginine. The improved pharmacological profile and greater early glucose‐lowering action of faster aspart compared with IAsp suggests that faster aspart may be advantageous for people with diabetes using continuous subcutaneous insulin infusion (CSII). The recent onset 5 trial was the first to evaluate the efficacy and safety of an ultra‐fast‐acting insulin in CSII therapy in a large number of participants with type 1 diabetes (T1D). Non‐inferiority of faster aspart to IAsp in terms of change from baseline in HbA1c was confirmed, with an estimated treatment difference (ETD) of 0.09% (95% CI, 0.01; 0.17; P < 0.001 for non‐inferiority [0.4% margin]). Faster aspart was superior to IAsp in terms of change from baseline in 1‐hour post‐prandial glucose (PPG) increment after a meal test (ETD [95% CI], −0.91 mmol/L [−1.43; −0.39]; P = 0.001), with statistically significant improvements also at 30 minutes and 2 hours. The overall rate of severe or blood glucose‐confirmed hypoglycaemia was not statistically significantly different between treatments, with an estimated rate ratio of 1.00 (95% CI, 0.85; 1.16). A numerical imbalance in severe hypoglycaemic episodes between faster aspart and IAsp was seen in the treatment (21 vs 7) and the 4‐week run‐in periods (4 vs 0). Experience from clinical practice indicates that all pump settings should be reviewed when initiating faster aspart with CSII, and that the use of continuous glucose monitoring or flash glucose monitoring, along with a good understanding of meal content and bolus type, may also facilitate optimal use. This review summarizes the available clinical evidence for faster aspart administered via CSII and highlights practical considerations based on clinical experience that may help healthcare providers and individuals with T1D successfully initiate and adjust faster aspart with CSII.

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Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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

Evans

Ceriello

Danne

et al. 2019

Diabetes Obesity Metabolism

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“…Participants will receive single doses (0.15 U/kg) of BioChaperone Lispro, Fiasp, and NovoLog via pump on three separate visits. Previously, BioChaperone Lispro has demonstrated an accelerated insulin action profile versus traditional prandial insulins, both via syringes and pumps, and in patients with T1D and T2D . This study will show how Adocia's candidate compares with other ultrarapid acting insulins.…”

Section: Company Updatesmentioning

confidence: 88%

Practical Ways to Achieve Targets in Diabetes Care 2017

Carracher

Marathe

2017

Journal of Diabetes

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Ann M. Carracher, Payal H. Marathe, and Kelly L. Close are of Close Concerns (http://www.closeconcerns.com), a healthcare information company focused exclusively on diabetes and obesity care. Close Concerns publishes Closer Look, a periodical that brings together news and insights in these areas. Each month, the Journal of Diabetes includes this News feature, in which Carracher, Marathe, and Close review the latest developments relevant to researchers and clinicians.

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“…The majority of the faster aspart trials have been published, while results of the trials for ultra‐rapid lispro are currently only in abstract form . Two of the BioChaperone Lispro trials have been published with several trials reported as abstracts . Key findings from the completed trials are summarized below.…”

Section: Second Generation Rapid‐acting Insulin Analoguesmentioning

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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Ultra‐rapid BioChaperone Lispro improves postprandial blood glucose excursions vs insulin lispro in a 14‐day crossover treatment study in people with type 1 diabetes

Abstract: BCLIS was well tolerated and safe over 14 days of treatment and significantly improved postprandial BG vs LIS when administered at mealtime.

Cited by 33 publications

References 3 publications

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

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

Practical Ways to Achieve Targets in Diabetes Care 2017

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

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