Diabetologie und Stoffwechsel 2017; 12(S 01): S1-S84
DOI: 10.1055/s-0037-1601688
Poster: *Poster + Kurzpräsentation
Typ-1-Diabetes
Georg Thieme Verlag KG Stuttgart · New York

Ultra-rapid BioChaperone Lispro ameliorates postprandial blood glucose (PPBG) in a group with diabetes mellitus

G Andersen
1  Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
,
G Meiffren
2  Adocia, Lyon, France
,
B Alluis
2  Adocia, Lyon, France
,
A Ranson
2  Adocia, Lyon, France
,
R Soula
2  Adocia, Lyon, France
,
M Gaudier
2  Adocia, Lyon, France
,
O Soula
2  Adocia, Lyon, France
,
C Kazda
3  Lilly France, Neuilly-sur-Seine, France
,
T Heise
1  Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
,
S Bruce
2  Adocia, Lyon, France
› Author Affiliations
Further Information

Publication History

Publication Date:
05 May 2017 (online)

 

Research Question:

BioChaperone Lispro (BCLIS) is an ultra-rapid insulin lispro (LIS) formulation designed to better mimic the physiological timing of prandial insulin action. The primary objective of this study was to compare the PPBG after administration of BCLIS and LIS in subjects with type 1 diabetes.

Methodology:

In this double-blind cross-over study, 38 subjects with type 1 diabetes (mean ± SD duration: 23 ± 9yrs; age: 44 ± 13yrs; BMI: 25 ± 2 kg/m2; HbA1c: 7.4 ± 0.9%) received a single subcutaneous dose (0.2 U/kg) of BCLIS or LIS at the start of a standardized liquid meal ingestion (600 kcal; 80 g carbohydrates; 25 g proteins; 20 g fat). Pre-meal BG was controlled at 100 mg/dL.

Findings:

Compared to LIS, BCLIS exhibited a statistically significant higher early insulin exposure post-dosing (Least square means ratio [95% CI] AUC0 – 30 min: 2.68 [2.18; 3.30]; AUC0 – 1h: 1.52 [1.37; 1.68]), a lower late exposure (AUC2 – 8h: 0.79 [0.72; 0.87]) and earlier time to early and late 50% Tmax (T0.5 max early: 0.63 [0.57; 0.71]; T0.5 max late= 0.85 [0.79; 0.91]) and Tmax (0.75 [0.69; 0.83]). Compared to LIS, BCLIS significantly reduced the mean PPBG value 1h (BG1h) and 2h (BG2h) by 42 and 27 mg/dL, respectively and also decreased the incremental AUCBG over the 2 first hours (ΔAUCBG 0 – 2h) by 61%, thus significantly controlling PPBG. The number of hypoglycemic events after each medication was similar and there were no safety or local tolerance issue.

Conclusion:

In conclusion, ultra-rapid BCLIS is more rapidly absorbed and improves PPBG control in comparison to LIS.