A randomized crossover study of the efficacy and safety of switching from insulin glargine to insulin degludec in children with type 1 diabetes
This study implemented a randomized crossover design to evaluate the efficacy and safety of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in 18 children (11 males, 7 females; age 11.0 ± 0.5 years) with type 1 diabetes. All subjects had previously used IGlar once daily at bedtime...
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Veröffentlicht in: | Endocrine Journal 2017, Vol.64(2), pp.133-140 |
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description | This study implemented a randomized crossover design to evaluate the efficacy and safety of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in 18 children (11 males, 7 females; age 11.0 ± 0.5 years) with type 1 diabetes. All subjects had previously used IGlar once daily at bedtime. We compared fasting plasma glucose (FPG) and HbA1c levels, frequencies of overall and nocturnal (2200 h - 0659 h) hypoglycemia, and basal insulin dose at the baseline with those measured during a 24-week period during which IGlar or IDeg was administered in combination with pre-meal rapid acting insulin analogues. IDeg was initially given at the same dose as IGlar but was subsequently titrated to achieve FPG levels of 90-140 mg/dL. There were no significant changes in FPG and HbA1c levels from the baseline during the 24-week study period with IGlar or IDeg. The daily basal insulin dose did not significantly differ with IGlar or IDeg. Although the frequencies of overall hypoglycemia were similar, nocturnal hypoglycemia significantly decreased at 12 and 24 weeks from the baseline with IDeg use (2 ± 0.4 vs. 0 ± 0.3, 0 ± 0.5 episodes/month, both P |
doi_str_mv | 10.1507/endocrj.EJ16-0294 |
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All subjects had previously used IGlar once daily at bedtime. We compared fasting plasma glucose (FPG) and HbA1c levels, frequencies of overall and nocturnal (2200 h - 0659 h) hypoglycemia, and basal insulin dose at the baseline with those measured during a 24-week period during which IGlar or IDeg was administered in combination with pre-meal rapid acting insulin analogues. IDeg was initially given at the same dose as IGlar but was subsequently titrated to achieve FPG levels of 90-140 mg/dL. There were no significant changes in FPG and HbA1c levels from the baseline during the 24-week study period with IGlar or IDeg. The daily basal insulin dose did not significantly differ with IGlar or IDeg. Although the frequencies of overall hypoglycemia were similar, nocturnal hypoglycemia significantly decreased at 12 and 24 weeks from the baseline with IDeg use (2 ± 0.4 vs. 0 ± 0.3, 0 ± 0.5 episodes/month, both P <0.05), whereas no significant change in the frequency of nocturnal hypoglycemia was observed with IGlar. No severe hypoglycemia occurred during the study period with either basal insulin analogues. These results suggest that IDeg, injected once at bedtime, may provide similar glycemic control as IGlar while better reducing the risk of nocturnal hypoglycemia in children with type 1 diabetes.</description><identifier>ISSN: 0918-8959</identifier><identifier>EISSN: 1348-4540</identifier><identifier>DOI: 10.1507/endocrj.EJ16-0294</identifier><identifier>PMID: 27746408</identifier><language>eng</language><publisher>Japan: The Japan Endocrine Society</publisher><subject>Adolescent ; Blood Glucose - drug effects ; Blood Glucose - metabolism ; Child ; Children ; Cross-Over Studies ; Diabetes Mellitus, Type 1 - drug therapy ; Diabetes Mellitus, Type 1 - epidemiology ; Drug Substitution - adverse effects ; Female ; Glycemic control ; Humans ; Hypoglycemia ; Hypoglycemia - blood ; Hypoglycemia - chemically induced ; Hypoglycemia - epidemiology ; Hypoglycemic Agents - therapeutic use ; Incidence ; Insulin degludec ; Insulin Glargine - therapeutic use ; Insulin, Long-Acting - therapeutic use ; Male ; Treatment Outcome ; Type 1 diabetes</subject><ispartof>Endocrine Journal, 2017, Vol.64(2), pp.133-140</ispartof><rights>The Japan Endocrine Society</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c531t-efa8be3d3eda80ecdefdf349f17cc69893ac9dcd38323593e9ec1f49832f2b8d3</citedby><cites>FETCH-LOGICAL-c531t-efa8be3d3eda80ecdefdf349f17cc69893ac9dcd38323593e9ec1f49832f2b8d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1883,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27746408$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Urakami, Tatsuhiko</creatorcontrib><creatorcontrib>Mine, Yusuke</creatorcontrib><creatorcontrib>Aoki, Masako</creatorcontrib><creatorcontrib>Okuno, Misako</creatorcontrib><creatorcontrib>Suzuki, Junichi</creatorcontrib><title>A randomized crossover study of the efficacy and safety of switching from insulin glargine to insulin degludec in children with type 1 diabetes</title><title>Endocrine Journal</title><addtitle>Endocr J</addtitle><description>This study implemented a randomized crossover design to evaluate the efficacy and safety of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in 18 children (11 males, 7 females; age 11.0 ± 0.5 years) with type 1 diabetes. All subjects had previously used IGlar once daily at bedtime. We compared fasting plasma glucose (FPG) and HbA1c levels, frequencies of overall and nocturnal (2200 h - 0659 h) hypoglycemia, and basal insulin dose at the baseline with those measured during a 24-week period during which IGlar or IDeg was administered in combination with pre-meal rapid acting insulin analogues. IDeg was initially given at the same dose as IGlar but was subsequently titrated to achieve FPG levels of 90-140 mg/dL. There were no significant changes in FPG and HbA1c levels from the baseline during the 24-week study period with IGlar or IDeg. The daily basal insulin dose did not significantly differ with IGlar or IDeg. Although the frequencies of overall hypoglycemia were similar, nocturnal hypoglycemia significantly decreased at 12 and 24 weeks from the baseline with IDeg use (2 ± 0.4 vs. 0 ± 0.3, 0 ± 0.5 episodes/month, both P <0.05), whereas no significant change in the frequency of nocturnal hypoglycemia was observed with IGlar. No severe hypoglycemia occurred during the study period with either basal insulin analogues. These results suggest that IDeg, injected once at bedtime, may provide similar glycemic control as IGlar while better reducing the risk of nocturnal hypoglycemia in children with type 1 diabetes.</description><subject>Adolescent</subject><subject>Blood Glucose - drug effects</subject><subject>Blood Glucose - metabolism</subject><subject>Child</subject><subject>Children</subject><subject>Cross-Over Studies</subject><subject>Diabetes Mellitus, Type 1 - drug therapy</subject><subject>Diabetes Mellitus, Type 1 - epidemiology</subject><subject>Drug Substitution - adverse effects</subject><subject>Female</subject><subject>Glycemic control</subject><subject>Humans</subject><subject>Hypoglycemia</subject><subject>Hypoglycemia - blood</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemia - epidemiology</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Incidence</subject><subject>Insulin degludec</subject><subject>Insulin Glargine - therapeutic use</subject><subject>Insulin, Long-Acting - therapeutic use</subject><subject>Male</subject><subject>Treatment Outcome</subject><subject>Type 1 diabetes</subject><issn>0918-8959</issn><issn>1348-4540</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkc1uEzEURi0EoqHtA7BBd8lmij32ZOxlVZUCqtRNWVuOfT1xND_B9oDCS_DKOE2YLRtbvj7fWdyPkPeM3rCGtp9wdJONu5v7b2xd0VqJV2TFuJCVaAR9TVZUMVlJ1agL8i6lHaWcN4K_JRd124q1oHJF_txCNEUzhN_owMYppeknRkh5dgeYPOQtAnofrLEHKCQk4zG_fKVfIdttGDvwcRogjGnuwwhdb2IXRoQ8LTOHXT87tGUAJdK7iCOU-BbyYY_AwAWzwYzpirzxpk94fb4vyffP9893X6rHp4evd7ePlW04yxV6IzfIHUdnJEXr0DvPhfKstXatpOLGKmcdl7zmjeKo0DIvVHn6eiMdvyQfT959nH7MmLIeQrLY92bEaU6aScnaRrEi-D9atipa3tCCshP6ssiIXu9jGEw8aEb1sTJ9rkwfK9PHykrmw1k_bwZ0S-JfRwV4OAG7lE2HC2BiDrbHRbkWuj4ei3oh7NbEgvG_L8mxQw</recordid><startdate>20170101</startdate><enddate>20170101</enddate><creator>Urakami, Tatsuhiko</creator><creator>Mine, Yusuke</creator><creator>Aoki, Masako</creator><creator>Okuno, Misako</creator><creator>Suzuki, Junichi</creator><general>The Japan Endocrine Society</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>20170101</creationdate><title>A randomized crossover study of the efficacy and safety of switching from insulin glargine to insulin degludec in children with type 1 diabetes</title><author>Urakami, Tatsuhiko ; Mine, Yusuke ; Aoki, Masako ; Okuno, Misako ; Suzuki, Junichi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c531t-efa8be3d3eda80ecdefdf349f17cc69893ac9dcd38323593e9ec1f49832f2b8d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Blood Glucose - drug effects</topic><topic>Blood Glucose - metabolism</topic><topic>Child</topic><topic>Children</topic><topic>Cross-Over Studies</topic><topic>Diabetes Mellitus, Type 1 - drug therapy</topic><topic>Diabetes Mellitus, Type 1 - epidemiology</topic><topic>Drug Substitution - adverse effects</topic><topic>Female</topic><topic>Glycemic control</topic><topic>Humans</topic><topic>Hypoglycemia</topic><topic>Hypoglycemia - blood</topic><topic>Hypoglycemia - chemically induced</topic><topic>Hypoglycemia - epidemiology</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Incidence</topic><topic>Insulin degludec</topic><topic>Insulin Glargine - therapeutic use</topic><topic>Insulin, Long-Acting - therapeutic use</topic><topic>Male</topic><topic>Treatment Outcome</topic><topic>Type 1 diabetes</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Urakami, Tatsuhiko</creatorcontrib><creatorcontrib>Mine, Yusuke</creatorcontrib><creatorcontrib>Aoki, Masako</creatorcontrib><creatorcontrib>Okuno, Misako</creatorcontrib><creatorcontrib>Suzuki, Junichi</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Endocrine Journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Urakami, Tatsuhiko</au><au>Mine, Yusuke</au><au>Aoki, Masako</au><au>Okuno, Misako</au><au>Suzuki, Junichi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized crossover study of the efficacy and safety of switching from insulin glargine to insulin degludec in children with type 1 diabetes</atitle><jtitle>Endocrine Journal</jtitle><addtitle>Endocr J</addtitle><date>2017-01-01</date><risdate>2017</risdate><volume>64</volume><issue>2</issue><spage>133</spage><epage>140</epage><pages>133-140</pages><issn>0918-8959</issn><eissn>1348-4540</eissn><abstract>This study implemented a randomized crossover design to evaluate the efficacy and safety of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in 18 children (11 males, 7 females; age 11.0 ± 0.5 years) with type 1 diabetes. All subjects had previously used IGlar once daily at bedtime. We compared fasting plasma glucose (FPG) and HbA1c levels, frequencies of overall and nocturnal (2200 h - 0659 h) hypoglycemia, and basal insulin dose at the baseline with those measured during a 24-week period during which IGlar or IDeg was administered in combination with pre-meal rapid acting insulin analogues. IDeg was initially given at the same dose as IGlar but was subsequently titrated to achieve FPG levels of 90-140 mg/dL. There were no significant changes in FPG and HbA1c levels from the baseline during the 24-week study period with IGlar or IDeg. The daily basal insulin dose did not significantly differ with IGlar or IDeg. Although the frequencies of overall hypoglycemia were similar, nocturnal hypoglycemia significantly decreased at 12 and 24 weeks from the baseline with IDeg use (2 ± 0.4 vs. 0 ± 0.3, 0 ± 0.5 episodes/month, both P <0.05), whereas no significant change in the frequency of nocturnal hypoglycemia was observed with IGlar. No severe hypoglycemia occurred during the study period with either basal insulin analogues. These results suggest that IDeg, injected once at bedtime, may provide similar glycemic control as IGlar while better reducing the risk of nocturnal hypoglycemia in children with type 1 diabetes.</abstract><cop>Japan</cop><pub>The Japan Endocrine Society</pub><pmid>27746408</pmid><doi>10.1507/endocrj.EJ16-0294</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adolescent Blood Glucose - drug effects Blood Glucose - metabolism Child Children Cross-Over Studies Diabetes Mellitus, Type 1 - drug therapy Diabetes Mellitus, Type 1 - epidemiology Drug Substitution - adverse effects Female Glycemic control Humans Hypoglycemia Hypoglycemia - blood Hypoglycemia - chemically induced Hypoglycemia - epidemiology Hypoglycemic Agents - therapeutic use Incidence Insulin degludec Insulin Glargine - therapeutic use Insulin, Long-Acting - therapeutic use Male Treatment Outcome Type 1 diabetes |
title | A randomized crossover study of the efficacy and safety of switching from insulin glargine to insulin degludec in children with type 1 diabetes |
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