Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension
Introduction The PRONTO-T1D study, which evaluated the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes (T1D), met the primary endpoint of noninferiority of HbA1c change from baseline compared to lispro at 26 weeks. We present results of an additional 26-...
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| creator | Bue-Valleskey, Juliana Klaff, Leslie Cho, Jang Ik Dellva, Mary Anne Schloot, Nanette C. Tobian, Janet Miura, Junnosuke Dahl, Dominik |
| description | Introduction
The PRONTO-T1D study, which evaluated the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes (T1D), met the primary endpoint of noninferiority of HbA1c change from baseline compared to lispro at 26 weeks. We present results of an additional 26-week treatment phase evaluating long-term efficacy and safety of URLi.
Methods
In this phase 3, treat-to-target study, subjects were randomized to double-blind mealtime URLi, lispro, or open-label postmeal URLi with insulin degludec or glargine for 26 weeks. Subjects in the double-blind URLi (
n
= 451) and lispro (
n
= 442) groups continued for another 26 weeks to assess long-term efficacy and safety.
Results
HbA1c increased marginally during the long-term maintenance period (week 26–52) in both groups to 7.47% (URLi) and 7.54% (lispro). At week 52, there were no statistically significant treatment differences in change from baseline HbA1c with a least-squares mean treatment difference (95% confidence interval) of − 0.06% (− 0.16, 0.03). Proportions of patients with HbA
1c
|
| doi_str_mv | 10.1007/s13300-020-00987-8 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7846637</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2512385815</sourcerecordid><originalsourceid>FETCH-LOGICAL-c474t-62db4f9208cedd18b0860d796c8307548841bc60a3a1cb97b139c924b605af933</originalsourceid><addsrcrecordid>eNp9kctu1DAUhi0EolXpC7BAltiURcCOHV9YIFXtcJEiBg2ZteU4zoyrjJ3aCTBvw7PwZBimDJcFlixb8nf-46MPgMcYPccI8RcJE4JQgcq8kRS8EPfAKRZMFkwyfP94r8gJOE_pBuVFpJQYPwQnhNBKCEROwVQHvykaG3dw0ffOaLOH2nfwo-7ttIehh-thihqu9Og6WLs0xgAv1qvaPYPOw8tuHqYEP7tpC5v9aL99xfDa6dZONr2EzdbCD6vl-2ZZNPgaLr5M1icX_CPwoNdDsud35xlYv140V2-Levnm3dVlXRjK6VSwsmtpL0skjO06LFokGOq4ZEYQxCsqBMWtYUgTjU0reYuJNLKkLUOV7iUhZ-DVIXec253tjPV5lEGN0e103Kugnfr7xbut2oRPigvKGOE54OIuIIbb2aZJ7Vwydhi0t2FOqqRccC4IRRl9-g96E-bo83iqrHBJRCVwlanyQJkYUoq2P34GI_XDqzp4Vdmr-ulViVz05M8xjiW_LGaAHIBsx_mNjb97_yf2O77ArCI</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2512385815</pqid></control><display><type>article</type><title>Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension</title><source>SpringerOpen(OpenAccess)</source><source>PubMed Central</source><source>Directory of Open Access Journals</source><source>EZB Electronic Journals Library</source><creator>Bue-Valleskey, Juliana ; Klaff, Leslie ; Cho, Jang Ik ; Dellva, Mary Anne ; Schloot, Nanette C. ; Tobian, Janet ; Miura, Junnosuke ; Dahl, Dominik</creator><creatorcontrib>Bue-Valleskey, Juliana ; Klaff, Leslie ; Cho, Jang Ik ; Dellva, Mary Anne ; Schloot, Nanette C. ; Tobian, Janet ; Miura, Junnosuke ; Dahl, Dominik</creatorcontrib><description>Introduction
The PRONTO-T1D study, which evaluated the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes (T1D), met the primary endpoint of noninferiority of HbA1c change from baseline compared to lispro at 26 weeks. We present results of an additional 26-week treatment phase evaluating long-term efficacy and safety of URLi.
Methods
In this phase 3, treat-to-target study, subjects were randomized to double-blind mealtime URLi, lispro, or open-label postmeal URLi with insulin degludec or glargine for 26 weeks. Subjects in the double-blind URLi (
n
= 451) and lispro (
n
= 442) groups continued for another 26 weeks to assess long-term efficacy and safety.
Results
HbA1c increased marginally during the long-term maintenance period (week 26–52) in both groups to 7.47% (URLi) and 7.54% (lispro). At week 52, there were no statistically significant treatment differences in change from baseline HbA1c with a least-squares mean treatment difference (95% confidence interval) of − 0.06% (− 0.16, 0.03). Proportions of patients with HbA
1c
< 7% at week 52 were similar (URLi, 26.8%; lispro, 24.5%). Self-monitored blood glucose (SMBG) showed that 1-h (9.23 versus 10.14 mmol/L) and 2-h (8.40 versus 9.53 mmol/L) postmeal daily mean glucose was statistically significantly (
p
< 0.001) lower with URLi than lispro. The rate and incidence of severe, documented, and postprandial hypoglycemia (< 54 mg/dl [3.0 mmol/L]) were similar between treatments, but URLi demonstrated a 31% lower rate in the period more than 4 h after meals, (
p
= 0.023). Injection site reactions were reported by 3.3% of patients on URLi and 0.9% on lispro. The incidence of treatment-emergent adverse events was similar between treatments.
Conclusion
Overall glycemic control and improved postprandial glucose via SMBG were maintained after 52 weeks with URLi versus lispro, suggesting that the efficacy of URLi is preserved during long-term treatment in patients with T1D. No long-term safety issues were identified with URLi.
Trial Registration
ClinicalTrials.gov, NCT03214367.</description><identifier>ISSN: 1869-6953</identifier><identifier>EISSN: 1869-6961</identifier><identifier>DOI: 10.1007/s13300-020-00987-8</identifier><identifier>PMID: 33458803</identifier><language>eng</language><publisher>Cheshire: Springer Healthcare</publisher><subject>Cardiology ; Diabetes ; Drug therapy ; Endocrinology ; Glucose ; Hypoglycemia ; Insulin ; Internal Medicine ; Medicine ; Medicine & Public Health ; Original Research</subject><ispartof>Diabetes therapy, 2021-02, Vol.12 (2), p.569-580</ispartof><rights>The Author(s) 2021</rights><rights>The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-62db4f9208cedd18b0860d796c8307548841bc60a3a1cb97b139c924b605af933</citedby><cites>FETCH-LOGICAL-c474t-62db4f9208cedd18b0860d796c8307548841bc60a3a1cb97b139c924b605af933</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7846637/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7846637/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27903,27904,41099,42168,51555,53770,53772</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33458803$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bue-Valleskey, Juliana</creatorcontrib><creatorcontrib>Klaff, Leslie</creatorcontrib><creatorcontrib>Cho, Jang Ik</creatorcontrib><creatorcontrib>Dellva, Mary Anne</creatorcontrib><creatorcontrib>Schloot, Nanette C.</creatorcontrib><creatorcontrib>Tobian, Janet</creatorcontrib><creatorcontrib>Miura, Junnosuke</creatorcontrib><creatorcontrib>Dahl, Dominik</creatorcontrib><title>Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension</title><title>Diabetes therapy</title><addtitle>Diabetes Ther</addtitle><addtitle>Diabetes Ther</addtitle><description>Introduction
The PRONTO-T1D study, which evaluated the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes (T1D), met the primary endpoint of noninferiority of HbA1c change from baseline compared to lispro at 26 weeks. We present results of an additional 26-week treatment phase evaluating long-term efficacy and safety of URLi.
Methods
In this phase 3, treat-to-target study, subjects were randomized to double-blind mealtime URLi, lispro, or open-label postmeal URLi with insulin degludec or glargine for 26 weeks. Subjects in the double-blind URLi (
n
= 451) and lispro (
n
= 442) groups continued for another 26 weeks to assess long-term efficacy and safety.
Results
HbA1c increased marginally during the long-term maintenance period (week 26–52) in both groups to 7.47% (URLi) and 7.54% (lispro). At week 52, there were no statistically significant treatment differences in change from baseline HbA1c with a least-squares mean treatment difference (95% confidence interval) of − 0.06% (− 0.16, 0.03). Proportions of patients with HbA
1c
< 7% at week 52 were similar (URLi, 26.8%; lispro, 24.5%). Self-monitored blood glucose (SMBG) showed that 1-h (9.23 versus 10.14 mmol/L) and 2-h (8.40 versus 9.53 mmol/L) postmeal daily mean glucose was statistically significantly (
p
< 0.001) lower with URLi than lispro. The rate and incidence of severe, documented, and postprandial hypoglycemia (< 54 mg/dl [3.0 mmol/L]) were similar between treatments, but URLi demonstrated a 31% lower rate in the period more than 4 h after meals, (
p
= 0.023). Injection site reactions were reported by 3.3% of patients on URLi and 0.9% on lispro. The incidence of treatment-emergent adverse events was similar between treatments.
Conclusion
Overall glycemic control and improved postprandial glucose via SMBG were maintained after 52 weeks with URLi versus lispro, suggesting that the efficacy of URLi is preserved during long-term treatment in patients with T1D. No long-term safety issues were identified with URLi.
Trial Registration
ClinicalTrials.gov, NCT03214367.</description><subject>Cardiology</subject><subject>Diabetes</subject><subject>Drug therapy</subject><subject>Endocrinology</subject><subject>Glucose</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Research</subject><issn>1869-6953</issn><issn>1869-6961</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNp9kctu1DAUhi0EolXpC7BAltiURcCOHV9YIFXtcJEiBg2ZteU4zoyrjJ3aCTBvw7PwZBimDJcFlixb8nf-46MPgMcYPccI8RcJE4JQgcq8kRS8EPfAKRZMFkwyfP94r8gJOE_pBuVFpJQYPwQnhNBKCEROwVQHvykaG3dw0ffOaLOH2nfwo-7ttIehh-thihqu9Og6WLs0xgAv1qvaPYPOw8tuHqYEP7tpC5v9aL99xfDa6dZONr2EzdbCD6vl-2ZZNPgaLr5M1icX_CPwoNdDsud35xlYv140V2-Levnm3dVlXRjK6VSwsmtpL0skjO06LFokGOq4ZEYQxCsqBMWtYUgTjU0reYuJNLKkLUOV7iUhZ-DVIXec253tjPV5lEGN0e103Kugnfr7xbut2oRPigvKGOE54OIuIIbb2aZJ7Vwydhi0t2FOqqRccC4IRRl9-g96E-bo83iqrHBJRCVwlanyQJkYUoq2P34GI_XDqzp4Vdmr-ulViVz05M8xjiW_LGaAHIBsx_mNjb97_yf2O77ArCI</recordid><startdate>20210201</startdate><enddate>20210201</enddate><creator>Bue-Valleskey, Juliana</creator><creator>Klaff, Leslie</creator><creator>Cho, Jang Ik</creator><creator>Dellva, Mary Anne</creator><creator>Schloot, Nanette C.</creator><creator>Tobian, Janet</creator><creator>Miura, Junnosuke</creator><creator>Dahl, Dominik</creator><general>Springer Healthcare</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20210201</creationdate><title>Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension</title><author>Bue-Valleskey, Juliana ; Klaff, Leslie ; Cho, Jang Ik ; Dellva, Mary Anne ; Schloot, Nanette C. ; Tobian, Janet ; Miura, Junnosuke ; Dahl, Dominik</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-62db4f9208cedd18b0860d796c8307548841bc60a3a1cb97b139c924b605af933</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Cardiology</topic><topic>Diabetes</topic><topic>Drug therapy</topic><topic>Endocrinology</topic><topic>Glucose</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Research</topic><toplevel>online_resources</toplevel><creatorcontrib>Bue-Valleskey, Juliana</creatorcontrib><creatorcontrib>Klaff, Leslie</creatorcontrib><creatorcontrib>Cho, Jang Ik</creatorcontrib><creatorcontrib>Dellva, Mary Anne</creatorcontrib><creatorcontrib>Schloot, Nanette C.</creatorcontrib><creatorcontrib>Tobian, Janet</creatorcontrib><creatorcontrib>Miura, Junnosuke</creatorcontrib><creatorcontrib>Dahl, Dominik</creatorcontrib><collection>SpringerOpen(OpenAccess)</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Nursing and Allied Health Source</collection><collection>ProQuest Health and Medical</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetes therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bue-Valleskey, Juliana</au><au>Klaff, Leslie</au><au>Cho, Jang Ik</au><au>Dellva, Mary Anne</au><au>Schloot, Nanette C.</au><au>Tobian, Janet</au><au>Miura, Junnosuke</au><au>Dahl, Dominik</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension</atitle><jtitle>Diabetes therapy</jtitle><stitle>Diabetes Ther</stitle><addtitle>Diabetes Ther</addtitle><date>2021-02-01</date><risdate>2021</risdate><volume>12</volume><issue>2</issue><spage>569</spage><epage>580</epage><pages>569-580</pages><issn>1869-6953</issn><eissn>1869-6961</eissn><abstract>Introduction
The PRONTO-T1D study, which evaluated the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes (T1D), met the primary endpoint of noninferiority of HbA1c change from baseline compared to lispro at 26 weeks. We present results of an additional 26-week treatment phase evaluating long-term efficacy and safety of URLi.
Methods
In this phase 3, treat-to-target study, subjects were randomized to double-blind mealtime URLi, lispro, or open-label postmeal URLi with insulin degludec or glargine for 26 weeks. Subjects in the double-blind URLi (
n
= 451) and lispro (
n
= 442) groups continued for another 26 weeks to assess long-term efficacy and safety.
Results
HbA1c increased marginally during the long-term maintenance period (week 26–52) in both groups to 7.47% (URLi) and 7.54% (lispro). At week 52, there were no statistically significant treatment differences in change from baseline HbA1c with a least-squares mean treatment difference (95% confidence interval) of − 0.06% (− 0.16, 0.03). Proportions of patients with HbA
1c
< 7% at week 52 were similar (URLi, 26.8%; lispro, 24.5%). Self-monitored blood glucose (SMBG) showed that 1-h (9.23 versus 10.14 mmol/L) and 2-h (8.40 versus 9.53 mmol/L) postmeal daily mean glucose was statistically significantly (
p
< 0.001) lower with URLi than lispro. The rate and incidence of severe, documented, and postprandial hypoglycemia (< 54 mg/dl [3.0 mmol/L]) were similar between treatments, but URLi demonstrated a 31% lower rate in the period more than 4 h after meals, (
p
= 0.023). Injection site reactions were reported by 3.3% of patients on URLi and 0.9% on lispro. The incidence of treatment-emergent adverse events was similar between treatments.
Conclusion
Overall glycemic control and improved postprandial glucose via SMBG were maintained after 52 weeks with URLi versus lispro, suggesting that the efficacy of URLi is preserved during long-term treatment in patients with T1D. No long-term safety issues were identified with URLi.
Trial Registration
ClinicalTrials.gov, NCT03214367.</abstract><cop>Cheshire</cop><pub>Springer Healthcare</pub><pmid>33458803</pmid><doi>10.1007/s13300-020-00987-8</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Cardiology Diabetes Drug therapy Endocrinology Glucose Hypoglycemia Insulin Internal Medicine Medicine Medicine & Public Health Original Research |
| title | Long-Term Efficacy and Safety of Ultra Rapid Lispro (URLi) in Adults with Type 1 Diabetes: The PRONTO-T1D Extension |
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