Pooled Analysis of Clinical Trials Investigating the Pharmacokinetics (PK) of Ultra-rapid Insulin BioChaperone Lispro (BCLIS) vs. Lispro (LIS) in Subjects with Type 1 (T1D) and Type 2 (T2D) Diabetes

Pooled Analysis of Clinical Trials Investigating the Pharmacokinetics (PK) of Ultra-rapid Insulin BioChaperone Lispro (BCLIS) vs. Lispro (LIS) in Subjects with Type 1 (T1D) and Type 2 (T2D) Diabetes

BCLIS is an ultra-rapid insulin lispro formulation designed to accelerate the time-action profile vs. conventional short-acting insulin analogs. PK characteristics of single doses of BCLIS and LIS were characterized in four randomized, double-blind, crossover studies in altogether 112 T1D and 51 T2D...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Diabetes (New York, N.Y.) N.Y.), 2018-07, Vol.67 (Supplement_1)
Hauptverfasser: HEISE, TIM, RANSON, AYMERIC, GAUDIER, MARTIN, SOULA, OLIVIER, ALLUIS, BERTRAND, ZIJLSTRA, ERIC, GLEZER, STANISLAV, MEIFFREN, GRÉGORY
Format: Artikel
Sprache:eng
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page
container_issue Supplement_1
container_start_page
container_title Diabetes (New York, N.Y.)
container_volume 67
creator HEISE, TIM
RANSON, AYMERIC
GAUDIER, MARTIN
SOULA, OLIVIER
ALLUIS, BERTRAND
ZIJLSTRA, ERIC
GLEZER, STANISLAV
MEIFFREN, GRÉGORY
description BCLIS is an ultra-rapid insulin lispro formulation designed to accelerate the time-action profile vs. conventional short-acting insulin analogs. PK characteristics of single doses of BCLIS and LIS were characterized in four randomized, double-blind, crossover studies in altogether 112 T1D and 51 T2D subjects who received BCLIS and LIS (0.2 U/kg in studies 1 and 2, individualized doses in studies 3 and 4) subcutaneously by syringe. Insulin absorption was consistently faster with BCLIS than with LIS as indicated by reaching early half-maximum insulin levels (early t50%max) 8.4 (95% confidence interval [-9.6;-7.2]) and time to maximum levels (tmax) 10.0 [-14.3;-5.8] min earlier (p
doi_str_mv 10.2337/db18-998-P
format Article
fullrecord <record><control><sourceid>crossref</sourceid><recordid>TN_cdi_crossref_primary_10_2337_db18_998_P</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>10_2337_db18_998_P</sourcerecordid><originalsourceid>FETCH-crossref_primary_10_2337_db18_998_P3</originalsourceid><addsrcrecordid>eNqVkE1Lw0AQhhdRsH5c_AVzbIXU3QRMc7SpYrGHQCN4C5tk20xNd8POtpI_6O9yo-Jd5jDw8L7D8DB2I_g0jKL4ri7FLEiSWZCdsJFIoiSIwvjtlI04F2Eg4iQ-ZxdEO875vZ8R-8yMaVUND1q2PSGB2UDaosZKtpBblC3BUh8VOdxKh3oLrlGQNdLuZWXeUSuHFcE4e5kM1dfWWRlY2WHta3Twl2COJm1kp6zRClZInTUwnqer5XoCR5r-oW_g8-tDuVOVI_hA10DedwoEjHOxmIDU9Q8IPQg9WKAslVN0xc42_lV1_bsv2e3TY54-B5U1RFZtis7iXtq-ELwYTBWDqcKbKrLoX-EvvzZvAw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Pooled Analysis of Clinical Trials Investigating the Pharmacokinetics (PK) of Ultra-rapid Insulin BioChaperone Lispro (BCLIS) vs. Lispro (LIS) in Subjects with Type 1 (T1D) and Type 2 (T2D) Diabetes</title><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>HEISE, TIM ; RANSON, AYMERIC ; GAUDIER, MARTIN ; SOULA, OLIVIER ; ALLUIS, BERTRAND ; ZIJLSTRA, ERIC ; GLEZER, STANISLAV ; MEIFFREN, GRÉGORY</creator><creatorcontrib>HEISE, TIM ; RANSON, AYMERIC ; GAUDIER, MARTIN ; SOULA, OLIVIER ; ALLUIS, BERTRAND ; ZIJLSTRA, ERIC ; GLEZER, STANISLAV ; MEIFFREN, GRÉGORY</creatorcontrib><description>BCLIS is an ultra-rapid insulin lispro formulation designed to accelerate the time-action profile vs. conventional short-acting insulin analogs. PK characteristics of single doses of BCLIS and LIS were characterized in four randomized, double-blind, crossover studies in altogether 112 T1D and 51 T2D subjects who received BCLIS and LIS (0.2 U/kg in studies 1 and 2, individualized doses in studies 3 and 4) subcutaneously by syringe. Insulin absorption was consistently faster with BCLIS than with LIS as indicated by reaching early half-maximum insulin levels (early t50%max) 8.4 (95% confidence interval [-9.6;-7.2]) and time to maximum levels (tmax) 10.0 [-14.3;-5.8] min earlier (p&lt;0.0001 for both comparisons). Early insulin exposure was significantly greater for BCLIS for up to 2 hours after administration (Figure). BCLIS also showed faster offset of exposure, with a 22.3 [-28.8;-15.7] min earlier time to late half-maximum insulin levels (late t50%max) (p&lt;0.0001) and a 24% lower late exposure (AUC2-6h; Figure). Total exposure (AUC0-6h) was similar for both formulations in all studies (treatment ratio in pooled analysis 0.99 [0.95;1.03], p=NS). In conclusion, BCLIS consistently shows faster onset and offset of exposure than conventional LIS in both T1D and T2D.</description><identifier>ISSN: 0012-1797</identifier><identifier>EISSN: 1939-327X</identifier><identifier>DOI: 10.2337/db18-998-P</identifier><language>eng</language><ispartof>Diabetes (New York, N.Y.), 2018-07, Vol.67 (Supplement_1)</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>HEISE, TIM</creatorcontrib><creatorcontrib>RANSON, AYMERIC</creatorcontrib><creatorcontrib>GAUDIER, MARTIN</creatorcontrib><creatorcontrib>SOULA, OLIVIER</creatorcontrib><creatorcontrib>ALLUIS, BERTRAND</creatorcontrib><creatorcontrib>ZIJLSTRA, ERIC</creatorcontrib><creatorcontrib>GLEZER, STANISLAV</creatorcontrib><creatorcontrib>MEIFFREN, GRÉGORY</creatorcontrib><title>Pooled Analysis of Clinical Trials Investigating the Pharmacokinetics (PK) of Ultra-rapid Insulin BioChaperone Lispro (BCLIS) vs. Lispro (LIS) in Subjects with Type 1 (T1D) and Type 2 (T2D) Diabetes</title><title>Diabetes (New York, N.Y.)</title><description>BCLIS is an ultra-rapid insulin lispro formulation designed to accelerate the time-action profile vs. conventional short-acting insulin analogs. PK characteristics of single doses of BCLIS and LIS were characterized in four randomized, double-blind, crossover studies in altogether 112 T1D and 51 T2D subjects who received BCLIS and LIS (0.2 U/kg in studies 1 and 2, individualized doses in studies 3 and 4) subcutaneously by syringe. Insulin absorption was consistently faster with BCLIS than with LIS as indicated by reaching early half-maximum insulin levels (early t50%max) 8.4 (95% confidence interval [-9.6;-7.2]) and time to maximum levels (tmax) 10.0 [-14.3;-5.8] min earlier (p&lt;0.0001 for both comparisons). Early insulin exposure was significantly greater for BCLIS for up to 2 hours after administration (Figure). BCLIS also showed faster offset of exposure, with a 22.3 [-28.8;-15.7] min earlier time to late half-maximum insulin levels (late t50%max) (p&lt;0.0001) and a 24% lower late exposure (AUC2-6h; Figure). Total exposure (AUC0-6h) was similar for both formulations in all studies (treatment ratio in pooled analysis 0.99 [0.95;1.03], p=NS). In conclusion, BCLIS consistently shows faster onset and offset of exposure than conventional LIS in both T1D and T2D.</description><issn>0012-1797</issn><issn>1939-327X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNqVkE1Lw0AQhhdRsH5c_AVzbIXU3QRMc7SpYrGHQCN4C5tk20xNd8POtpI_6O9yo-Jd5jDw8L7D8DB2I_g0jKL4ri7FLEiSWZCdsJFIoiSIwvjtlI04F2Eg4iQ-ZxdEO875vZ8R-8yMaVUND1q2PSGB2UDaosZKtpBblC3BUh8VOdxKh3oLrlGQNdLuZWXeUSuHFcE4e5kM1dfWWRlY2WHta3Twl2COJm1kp6zRClZInTUwnqer5XoCR5r-oW_g8-tDuVOVI_hA10DedwoEjHOxmIDU9Q8IPQg9WKAslVN0xc42_lV1_bsv2e3TY54-B5U1RFZtis7iXtq-ELwYTBWDqcKbKrLoX-EvvzZvAw</recordid><startdate>20180701</startdate><enddate>20180701</enddate><creator>HEISE, TIM</creator><creator>RANSON, AYMERIC</creator><creator>GAUDIER, MARTIN</creator><creator>SOULA, OLIVIER</creator><creator>ALLUIS, BERTRAND</creator><creator>ZIJLSTRA, ERIC</creator><creator>GLEZER, STANISLAV</creator><creator>MEIFFREN, GRÉGORY</creator><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20180701</creationdate><title>Pooled Analysis of Clinical Trials Investigating the Pharmacokinetics (PK) of Ultra-rapid Insulin BioChaperone Lispro (BCLIS) vs. Lispro (LIS) in Subjects with Type 1 (T1D) and Type 2 (T2D) Diabetes</title><author>HEISE, TIM ; RANSON, AYMERIC ; GAUDIER, MARTIN ; SOULA, OLIVIER ; ALLUIS, BERTRAND ; ZIJLSTRA, ERIC ; GLEZER, STANISLAV ; MEIFFREN, GRÉGORY</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-crossref_primary_10_2337_db18_998_P3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>HEISE, TIM</creatorcontrib><creatorcontrib>RANSON, AYMERIC</creatorcontrib><creatorcontrib>GAUDIER, MARTIN</creatorcontrib><creatorcontrib>SOULA, OLIVIER</creatorcontrib><creatorcontrib>ALLUIS, BERTRAND</creatorcontrib><creatorcontrib>ZIJLSTRA, ERIC</creatorcontrib><creatorcontrib>GLEZER, STANISLAV</creatorcontrib><creatorcontrib>MEIFFREN, GRÉGORY</creatorcontrib><collection>CrossRef</collection><jtitle>Diabetes (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>HEISE, TIM</au><au>RANSON, AYMERIC</au><au>GAUDIER, MARTIN</au><au>SOULA, OLIVIER</au><au>ALLUIS, BERTRAND</au><au>ZIJLSTRA, ERIC</au><au>GLEZER, STANISLAV</au><au>MEIFFREN, GRÉGORY</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pooled Analysis of Clinical Trials Investigating the Pharmacokinetics (PK) of Ultra-rapid Insulin BioChaperone Lispro (BCLIS) vs. Lispro (LIS) in Subjects with Type 1 (T1D) and Type 2 (T2D) Diabetes</atitle><jtitle>Diabetes (New York, N.Y.)</jtitle><date>2018-07-01</date><risdate>2018</risdate><volume>67</volume><issue>Supplement_1</issue><issn>0012-1797</issn><eissn>1939-327X</eissn><abstract>BCLIS is an ultra-rapid insulin lispro formulation designed to accelerate the time-action profile vs. conventional short-acting insulin analogs. PK characteristics of single doses of BCLIS and LIS were characterized in four randomized, double-blind, crossover studies in altogether 112 T1D and 51 T2D subjects who received BCLIS and LIS (0.2 U/kg in studies 1 and 2, individualized doses in studies 3 and 4) subcutaneously by syringe. Insulin absorption was consistently faster with BCLIS than with LIS as indicated by reaching early half-maximum insulin levels (early t50%max) 8.4 (95% confidence interval [-9.6;-7.2]) and time to maximum levels (tmax) 10.0 [-14.3;-5.8] min earlier (p&lt;0.0001 for both comparisons). Early insulin exposure was significantly greater for BCLIS for up to 2 hours after administration (Figure). BCLIS also showed faster offset of exposure, with a 22.3 [-28.8;-15.7] min earlier time to late half-maximum insulin levels (late t50%max) (p&lt;0.0001) and a 24% lower late exposure (AUC2-6h; Figure). Total exposure (AUC0-6h) was similar for both formulations in all studies (treatment ratio in pooled analysis 0.99 [0.95;1.03], p=NS). In conclusion, BCLIS consistently shows faster onset and offset of exposure than conventional LIS in both T1D and T2D.</abstract><doi>10.2337/db18-998-P</doi></addata></record>
fulltext fulltext
identifier ISSN: 0012-1797
ispartof Diabetes (New York, N.Y.), 2018-07, Vol.67 (Supplement_1)
issn 0012-1797
1939-327X
language eng
recordid cdi_crossref_primary_10_2337_db18_998_P
source EZB-FREE-00999 freely available EZB journals; PubMed Central
title Pooled Analysis of Clinical Trials Investigating the Pharmacokinetics (PK) of Ultra-rapid Insulin BioChaperone Lispro (BCLIS) vs. Lispro (LIS) in Subjects with Type 1 (T1D) and Type 2 (T2D) Diabetes
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-26T06%3A58%3A53IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-crossref&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Pooled%20Analysis%20of%20Clinical%20Trials%20Investigating%20the%20Pharmacokinetics%20(PK)%20of%20Ultra-rapid%20Insulin%20BioChaperone%20Lispro%20(BCLIS)%20vs.%20Lispro%20(LIS)%20in%20Subjects%20with%20Type%201%20(T1D)%20and%20Type%202%20(T2D)%20Diabetes&rft.jtitle=Diabetes%20(New%20York,%20N.Y.)&rft.au=HEISE,%20TIM&rft.date=2018-07-01&rft.volume=67&rft.issue=Supplement_1&rft.issn=0012-1797&rft.eissn=1939-327X&rft_id=info:doi/10.2337/db18-998-P&rft_dat=%3Ccrossref%3E10_2337_db18_998_P%3C/crossref%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_id=info:pmid/&rfr_iscdi=true