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Diabetes Obes Metab. 2019 Mar 3. doi: 10.1111/dom.13685. [Epub ahead of print]

Better glycemic control with BioChaperone Combo (BC Combo) than with insulin lispro Mix25 (LMix) or separate glargine & lispro (G+L) administrations after a test meal in subjects with type 2 diabetes (T2DM).

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Adocia, Lyon, France.
Profil, Neuss, Germany.
Profil, Mainz, Germany.



Due to its physico-chemical properties, insulin glargine is usually not mixable with rapid insulins. BioChaperone® BC147 is a polyanionic amphiphilic polymer solubilizing insulin glargine at neutral pH and thus enabling stable glargine formulation with fast-acting insulin lispro (BioChaperone glargine lispro Combo, BC Combo). We investigated the pharmacokinetics (PK) and post-prandial glucose (PPG) control after administration of BC Combo (75% insulin glargine, 25% insulin lispro), insulin lispro Mix25 (LMix) and separate injections of insulins glargine (75% total dose) & lispro (25% total dose) (G+L) immediately before ingestion of a mixed meal in patients with type 2 diabetes.


In this randomized, double-blind, double-dummy crossover study, patients received individualized bolus doses (mean 0.62 U/kg) of BC Combo, LMix or G+L, together with a solid mixed meal (610 kcal, 50% carbohydrate, 30% fat, 20% protein). Insulin dosages were kept constant for each study day.


Thirty-nine T2DM subjects (mean ± SD age 60.8 ± 7.5 years and HbA1c 8.0 ± 0.6 %) were randomized. BC Combo improved the predefined primary endpoint, early PPG control, compared to LMix (∆AUCBG,0-2h reduction of 18%, p=0.0009) and G+L (∆AUCBG,0-2h reduction of 10%, p=0.0450). The number of mealtime hypoglycemic episodes per subject was lower with BC Combo (22 episodes in 14 subjects) compared to LMix (43 episodes in 20 subjects) (p=0.0028) but not significantly different from G+L (28 episodes in 19 subjects) (p=0.2523).


BC Combo demonstrated superior early PPG control with fewer hypoglycemic episodes compared to lispro Mix25 and superior early PPG control compared to separate glargine & lispro administrations. This article is protected by copyright. All rights reserved.


Insulin analogs; glargine; lispro; pharmacokinetics; pre-mix insulin; type 2 diabetes


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