A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes
Introduction This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal–bolus regimen in insulin-naïve adults with type...
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| creator | Linjawi, Sultan Lee, Byung-Wan Tabak, Ömür Lövdahl, Susanna Werther, Shanti Abusnana, Salahedeen |
| description | Introduction
This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal–bolus regimen in insulin-naïve adults with type 2 diabetes (T2D) who continued pretrial treatment with metformin and sulfonylurea.
Methods
Adults with T2D were randomized into one of two treatment arms for 32 weeks: (1) BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID); (2) insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID. The primary endpoint was change from baseline in HbA
1c
after 32 weeks.
Results
After 32 weeks, the estimated mean change in HbA
1c
from baseline was statistically significantly lower in the BIAsp 30 arm (− 1.18%) versus basal–bolus (− 1.36%) [estimated treatment difference 0.18%; 95% confidence interval (95% CI) 0.01; 0.36;
p
|
| doi_str_mv | 10.1007/s13300-017-0334-8 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5801220</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1963475431</sourcerecordid><originalsourceid>FETCH-LOGICAL-c470t-59f3054afa8209edd0c82930fd05a0baf6003cd9e022aa63f24f1bfd06dd50163</originalsourceid><addsrcrecordid>eNp1ks9u1DAQxiMEolXpA3BBlriUQ2Bs558vSLsLlJUqQLDA0fImk65LEqeepNX2xDvwArwBR-7wJjwJbresChK-zFjzm88z1hdF9zk85gD5E-JSAsTA8xikTOLiVrTLi0zFmcr47W2eyp1on-gEwpFKKc7vRjtCcaGAF7vR9wmTIv6I-Im9NV3lWnuBFZu5tjfekuuYq9m7AftzS8jmHY2N7UIcsCNb29IMdsNMbb8yZMstM6GgMLCD6TxkP75KeMQ-oKeR2NSQaX59_jJ1TbgtVuhNv2ZXslet8Svz89sZsjdBHLuB2LkdVmyx7pEJ9syaJQ5I96I7tWkI96_jXvT-xfPF7GV89PpwPpscxWWSwxCnqpaQJqY2hQCFVQVlIZSEuoLUwNLUWfiVslIIQhiTyVokNV-GalZVKfBM7kVPN7r9uGyxKsNA3jS697Y1fq2dsfrvSmdX-tid6bQALgQEgYNrAe9OR6RBt5ZKbBrToRtJc5XJJE8TyQP68B_0xI2-C-sFSiW5zIssDxTfUKV3RB7r7TAc9KUz9MYZOjhDXzpDF6Hnwc0tth1_fBAAsQEolLpj9Dee_q_qb1qYx8o</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1994737867</pqid></control><display><type>article</type><title>A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes</title><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Springer Nature OA Free Journals</source><source>PubMed Central</source><creator>Linjawi, Sultan ; Lee, Byung-Wan ; Tabak, Ömür ; Lövdahl, Susanna ; Werther, Shanti ; Abusnana, Salahedeen</creator><creatorcontrib>Linjawi, Sultan ; Lee, Byung-Wan ; Tabak, Ömür ; Lövdahl, Susanna ; Werther, Shanti ; Abusnana, Salahedeen</creatorcontrib><description>Introduction
This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal–bolus regimen in insulin-naïve adults with type 2 diabetes (T2D) who continued pretrial treatment with metformin and sulfonylurea.
Methods
Adults with T2D were randomized into one of two treatment arms for 32 weeks: (1) BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID); (2) insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID. The primary endpoint was change from baseline in HbA
1c
after 32 weeks.
Results
After 32 weeks, the estimated mean change in HbA
1c
from baseline was statistically significantly lower in the BIAsp 30 arm (− 1.18%) versus basal–bolus (− 1.36%) [estimated treatment difference 0.18%; 95% confidence interval (95% CI) 0.01; 0.36;
p
< 0.05]. The proportion of patients with HbA
1c
below 7.0% was statistically significantly lower with BIAsp 30 (42.9%) compared with basal–bolus (56.9%) (odds ratio 0.58; 95% CI 0.37; 0.89;
p
= 0.01). The overall rate of severe or blood glucose (BG)-confirmed hypoglycemic events was numerically lower for BIAsp 30 compared with basal–bolus, and a statistically significantly lower rate in nocturnal severe or BG-confirmed hypoglycemia in the BIAsp 30 arm relative to basal–bolus was observed: estimated rate ratio 0.32 (95% CI 0.13; 0.79),
p
= 0.0131. The proportion of patients with adverse events was similar in both treatment arms.
Conclusion
Insulin intensification with BIAsp 30 and basal–bolus showed an improvement in glycemic control; the change in HbA
1c
was statistically significantly lower for BIAsp 30 compared to basal–bolus. Basal–bolus treatment was accompanied by a numerically, and statistically significantly, higher rate of overall and nocturnal severe or BG-confirmed hypoglycemia, respectively, compared with BIAsp 30.
Funding
Novo Nordisk A/S.
Trial Registration
ClinicalTrials.gov identifier, NCT02453685.</description><identifier>ISSN: 1869-6953</identifier><identifier>EISSN: 1869-6961</identifier><identifier>DOI: 10.1007/s13300-017-0334-8</identifier><identifier>PMID: 29129018</identifier><language>eng</language><publisher>Cheshire: Springer Healthcare</publisher><subject>Antidiabetics ; Cardiology ; Clinical outcomes ; Clinical trials ; Diabetes ; Drug therapy ; Endocrinology ; Glucose monitoring ; Hypoglycemia ; Insulin ; Internal Medicine ; Medicine ; Medicine & Public Health ; Original Research</subject><ispartof>Diabetes therapy, 2018-02, Vol.9 (1), p.1-11</ispartof><rights>The Author(s) 2017</rights><rights>Diabetes Therapy is a copyright of Springer, (2017). All Rights Reserved.</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c470t-59f3054afa8209edd0c82930fd05a0baf6003cd9e022aa63f24f1bfd06dd50163</citedby><cites>FETCH-LOGICAL-c470t-59f3054afa8209edd0c82930fd05a0baf6003cd9e022aa63f24f1bfd06dd50163</cites><orcidid>0000-0001-6276-7096</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5801220/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5801220/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,725,778,782,862,883,27911,27912,41107,42176,51563,53778,53780</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29129018$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Linjawi, Sultan</creatorcontrib><creatorcontrib>Lee, Byung-Wan</creatorcontrib><creatorcontrib>Tabak, Ömür</creatorcontrib><creatorcontrib>Lövdahl, Susanna</creatorcontrib><creatorcontrib>Werther, Shanti</creatorcontrib><creatorcontrib>Abusnana, Salahedeen</creatorcontrib><title>A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes</title><title>Diabetes therapy</title><addtitle>Diabetes Ther</addtitle><addtitle>Diabetes Ther</addtitle><description>Introduction
This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal–bolus regimen in insulin-naïve adults with type 2 diabetes (T2D) who continued pretrial treatment with metformin and sulfonylurea.
Methods
Adults with T2D were randomized into one of two treatment arms for 32 weeks: (1) BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID); (2) insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID. The primary endpoint was change from baseline in HbA
1c
after 32 weeks.
Results
After 32 weeks, the estimated mean change in HbA
1c
from baseline was statistically significantly lower in the BIAsp 30 arm (− 1.18%) versus basal–bolus (− 1.36%) [estimated treatment difference 0.18%; 95% confidence interval (95% CI) 0.01; 0.36;
p
< 0.05]. The proportion of patients with HbA
1c
below 7.0% was statistically significantly lower with BIAsp 30 (42.9%) compared with basal–bolus (56.9%) (odds ratio 0.58; 95% CI 0.37; 0.89;
p
= 0.01). The overall rate of severe or blood glucose (BG)-confirmed hypoglycemic events was numerically lower for BIAsp 30 compared with basal–bolus, and a statistically significantly lower rate in nocturnal severe or BG-confirmed hypoglycemia in the BIAsp 30 arm relative to basal–bolus was observed: estimated rate ratio 0.32 (95% CI 0.13; 0.79),
p
= 0.0131. The proportion of patients with adverse events was similar in both treatment arms.
Conclusion
Insulin intensification with BIAsp 30 and basal–bolus showed an improvement in glycemic control; the change in HbA
1c
was statistically significantly lower for BIAsp 30 compared to basal–bolus. Basal–bolus treatment was accompanied by a numerically, and statistically significantly, higher rate of overall and nocturnal severe or BG-confirmed hypoglycemia, respectively, compared with BIAsp 30.
Funding
Novo Nordisk A/S.
Trial Registration
ClinicalTrials.gov identifier, NCT02453685.</description><subject>Antidiabetics</subject><subject>Cardiology</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Drug therapy</subject><subject>Endocrinology</subject><subject>Glucose monitoring</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>2018</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>eNp1ks9u1DAQxiMEolXpA3BBlriUQ2Bs558vSLsLlJUqQLDA0fImk65LEqeepNX2xDvwArwBR-7wJjwJbresChK-zFjzm88z1hdF9zk85gD5E-JSAsTA8xikTOLiVrTLi0zFmcr47W2eyp1on-gEwpFKKc7vRjtCcaGAF7vR9wmTIv6I-Im9NV3lWnuBFZu5tjfekuuYq9m7AftzS8jmHY2N7UIcsCNb29IMdsNMbb8yZMstM6GgMLCD6TxkP75KeMQ-oKeR2NSQaX59_jJ1TbgtVuhNv2ZXslet8Svz89sZsjdBHLuB2LkdVmyx7pEJ9syaJQ5I96I7tWkI96_jXvT-xfPF7GV89PpwPpscxWWSwxCnqpaQJqY2hQCFVQVlIZSEuoLUwNLUWfiVslIIQhiTyVokNV-GalZVKfBM7kVPN7r9uGyxKsNA3jS697Y1fq2dsfrvSmdX-tid6bQALgQEgYNrAe9OR6RBt5ZKbBrToRtJc5XJJE8TyQP68B_0xI2-C-sFSiW5zIssDxTfUKV3RB7r7TAc9KUz9MYZOjhDXzpDF6Hnwc0tth1_fBAAsQEolLpj9Dee_q_qb1qYx8o</recordid><startdate>20180201</startdate><enddate>20180201</enddate><creator>Linjawi, Sultan</creator><creator>Lee, Byung-Wan</creator><creator>Tabak, Ömür</creator><creator>Lövdahl, Susanna</creator><creator>Werther, Shanti</creator><creator>Abusnana, Salahedeen</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><orcidid>https://orcid.org/0000-0001-6276-7096</orcidid></search><sort><creationdate>20180201</creationdate><title>A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes</title><author>Linjawi, Sultan ; Lee, Byung-Wan ; Tabak, Ömür ; Lövdahl, Susanna ; Werther, Shanti ; Abusnana, Salahedeen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c470t-59f3054afa8209edd0c82930fd05a0baf6003cd9e022aa63f24f1bfd06dd50163</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Antidiabetics</topic><topic>Cardiology</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Drug therapy</topic><topic>Endocrinology</topic><topic>Glucose monitoring</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>Linjawi, Sultan</creatorcontrib><creatorcontrib>Lee, Byung-Wan</creatorcontrib><creatorcontrib>Tabak, Ömür</creatorcontrib><creatorcontrib>Lövdahl, Susanna</creatorcontrib><creatorcontrib>Werther, Shanti</creatorcontrib><creatorcontrib>Abusnana, Salahedeen</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest 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 Edition)</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 Korea</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>Linjawi, Sultan</au><au>Lee, Byung-Wan</au><au>Tabak, Ömür</au><au>Lövdahl, Susanna</au><au>Werther, Shanti</au><au>Abusnana, Salahedeen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes</atitle><jtitle>Diabetes therapy</jtitle><stitle>Diabetes Ther</stitle><addtitle>Diabetes Ther</addtitle><date>2018-02-01</date><risdate>2018</risdate><volume>9</volume><issue>1</issue><spage>1</spage><epage>11</epage><pages>1-11</pages><issn>1869-6953</issn><eissn>1869-6961</eissn><abstract>Introduction
This 32-week, open-label, randomized, parallel-group, multinational trial aimed to compare the efficacy and safety of stepwise insulin intensification of biphasic insulin aspart 30 (BIAsp 30) relative to stepwise intensification of a basal–bolus regimen in insulin-naïve adults with type 2 diabetes (T2D) who continued pretrial treatment with metformin and sulfonylurea.
Methods
Adults with T2D were randomized into one of two treatment arms for 32 weeks: (1) BIAsp 30 once daily (OD), with the possibility of stepwise treatment intensification up to BIAsp 30 three times daily (TID); (2) insulin glargine OD, with the possibility of stepwise treatment intensification with insulin aspart up to TID. The primary endpoint was change from baseline in HbA
1c
after 32 weeks.
Results
After 32 weeks, the estimated mean change in HbA
1c
from baseline was statistically significantly lower in the BIAsp 30 arm (− 1.18%) versus basal–bolus (− 1.36%) [estimated treatment difference 0.18%; 95% confidence interval (95% CI) 0.01; 0.36;
p
< 0.05]. The proportion of patients with HbA
1c
below 7.0% was statistically significantly lower with BIAsp 30 (42.9%) compared with basal–bolus (56.9%) (odds ratio 0.58; 95% CI 0.37; 0.89;
p
= 0.01). The overall rate of severe or blood glucose (BG)-confirmed hypoglycemic events was numerically lower for BIAsp 30 compared with basal–bolus, and a statistically significantly lower rate in nocturnal severe or BG-confirmed hypoglycemia in the BIAsp 30 arm relative to basal–bolus was observed: estimated rate ratio 0.32 (95% CI 0.13; 0.79),
p
= 0.0131. The proportion of patients with adverse events was similar in both treatment arms.
Conclusion
Insulin intensification with BIAsp 30 and basal–bolus showed an improvement in glycemic control; the change in HbA
1c
was statistically significantly lower for BIAsp 30 compared to basal–bolus. Basal–bolus treatment was accompanied by a numerically, and statistically significantly, higher rate of overall and nocturnal severe or BG-confirmed hypoglycemia, respectively, compared with BIAsp 30.
Funding
Novo Nordisk A/S.
Trial Registration
ClinicalTrials.gov identifier, NCT02453685.</abstract><cop>Cheshire</cop><pub>Springer Healthcare</pub><pmid>29129018</pmid><doi>10.1007/s13300-017-0334-8</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-6276-7096</orcidid><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1869-6953 |
| ispartof | Diabetes therapy, 2018-02, Vol.9 (1), p.1-11 |
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| language | eng |
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| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Springer Nature OA Free Journals; PubMed Central |
| subjects | Antidiabetics Cardiology Clinical outcomes Clinical trials Diabetes Drug therapy Endocrinology Glucose monitoring Hypoglycemia Insulin Internal Medicine Medicine Medicine & Public Health Original Research |
| title | A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal–Bolus Therapy in Insulin-Naïve Patients with Type 2 Diabetes |
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