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Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin‐pump‐treated patients with type 1 diabetes: The Lira Pump trial—a randomized, double‐blinded, placebo‐controlled trial

Aim To investigate the efficacy of adding the glucagon‐like peptide‐1 receptor agonist liraglutide to continuous subcutaneous insulin infusion (CSII) in overweight or obese persons with type 1 diabetes and non‐optimal glycaemic control. Materials and methods A 26‐week, randomized, double‐blind, plac...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2020-04, Vol.22 (4), p.492-500
Main Authors: Dejgaard, Thomas F., Schmidt, Signe, Frandsen, Christian S., Vistisen, Dorte, Madsbad, Sten, Andersen, Henrik U., Nørgaard, Kirsten
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container_title Diabetes, obesity & metabolism
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creator Dejgaard, Thomas F.
Schmidt, Signe
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Madsbad, Sten
Andersen, Henrik U.
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description Aim To investigate the efficacy of adding the glucagon‐like peptide‐1 receptor agonist liraglutide to continuous subcutaneous insulin infusion (CSII) in overweight or obese persons with type 1 diabetes and non‐optimal glycaemic control. Materials and methods A 26‐week, randomized, double‐blind, placebo‐controlled trial including 44 overweight or obese adults with type 1 diabetes randomized 1:1 to liraglutide 1.8 mg once daily (QD) or placebo added to CSII treatment. The primary endpoint was change in haemoglobin A1c (HbA1c). Secondary endpoints included change in insulin dose, CSII settings, glycaemic variability, body weight and patient‐reported outcome measures. Finally, adverse effects including hypoglycaemic events were registered. Results HbA1c was reduced by 5 mmol/mol (0.5%) from a baseline of 66 mmol/mol (8.2%) in patients treated with liraglutide compared with a non‐significant change of +2.3 mmol/mol (0.2%) from a baseline of 66 mmol/mol (8.1%) in patients treated with placebo (between‐group difference 7 mmol/mol [0.7%], P
doi_str_mv 10.1111/dom.13911
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Materials and methods A 26‐week, randomized, double‐blind, placebo‐controlled trial including 44 overweight or obese adults with type 1 diabetes randomized 1:1 to liraglutide 1.8 mg once daily (QD) or placebo added to CSII treatment. The primary endpoint was change in haemoglobin A1c (HbA1c). Secondary endpoints included change in insulin dose, CSII settings, glycaemic variability, body weight and patient‐reported outcome measures. Finally, adverse effects including hypoglycaemic events were registered. Results HbA1c was reduced by 5 mmol/mol (0.5%) from a baseline of 66 mmol/mol (8.2%) in patients treated with liraglutide compared with a non‐significant change of +2.3 mmol/mol (0.2%) from a baseline of 66 mmol/mol (8.1%) in patients treated with placebo (between‐group difference 7 mmol/mol [0.7%], P &lt; 0.001). Liraglutide reduced total insulin dose by 8 units/day or 16% of total insulin dose (P = 0.008). Mean body weight was reduced by 6.3 kg (P &lt; 0.001) compared with placebo. Concomitantly, time spent in glycaemic target range 4–10 mmol/L (71–180 mg/dL) increased while the risk of hypoglycaemia did not differ between groups at the end of treatment. Conclusion Liraglutide treatment reduced HbA1c, total daily insulin dose and body weight without increasing the risk of hypoglycaemia in CSII‐treated patients with type 1 diabetes and insufficient glycaemic control. Liraglutide may be considered a potential add‐on therapy to insulin in this subgroup of patients.</description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.13911</identifier><identifier>PMID: 31696598</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Antidiabetics ; Body weight ; Clinical trials ; Diabetes ; Diabetes mellitus (insulin dependent) ; Drug therapy ; GLP-1 receptor agonists ; Glucagon ; Hemoglobin ; Hyperglycemia ; Hypoglycemia ; Insulin ; Obesity ; Overweight ; Weight control</subject><ispartof>Diabetes, obesity &amp; metabolism, 2020-04, Vol.22 (4), p.492-500</ispartof><rights>2019 John Wiley &amp; Sons Ltd</rights><rights>2019 John Wiley &amp; Sons Ltd.</rights><rights>2020 John Wiley &amp; Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3531-689da2ed1cd7f4f5af1f5e70efbaef9b16fa9a1479d264591ed7666e92eda7373</citedby><cites>FETCH-LOGICAL-c3531-689da2ed1cd7f4f5af1f5e70efbaef9b16fa9a1479d264591ed7666e92eda7373</cites><orcidid>0000-0002-0097-7052 ; 0000-0002-6968-6675</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31696598$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dejgaard, Thomas F.</creatorcontrib><creatorcontrib>Schmidt, Signe</creatorcontrib><creatorcontrib>Frandsen, Christian S.</creatorcontrib><creatorcontrib>Vistisen, Dorte</creatorcontrib><creatorcontrib>Madsbad, Sten</creatorcontrib><creatorcontrib>Andersen, Henrik U.</creatorcontrib><creatorcontrib>Nørgaard, Kirsten</creatorcontrib><title>Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin‐pump‐treated patients with type 1 diabetes: The Lira Pump trial—a randomized, double‐blinded, placebo‐controlled trial</title><title>Diabetes, obesity &amp; metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aim To investigate the efficacy of adding the glucagon‐like peptide‐1 receptor agonist liraglutide to continuous subcutaneous insulin infusion (CSII) in overweight or obese persons with type 1 diabetes and non‐optimal glycaemic control. Materials and methods A 26‐week, randomized, double‐blind, placebo‐controlled trial including 44 overweight or obese adults with type 1 diabetes randomized 1:1 to liraglutide 1.8 mg once daily (QD) or placebo added to CSII treatment. The primary endpoint was change in haemoglobin A1c (HbA1c). Secondary endpoints included change in insulin dose, CSII settings, glycaemic variability, body weight and patient‐reported outcome measures. Finally, adverse effects including hypoglycaemic events were registered. Results HbA1c was reduced by 5 mmol/mol (0.5%) from a baseline of 66 mmol/mol (8.2%) in patients treated with liraglutide compared with a non‐significant change of +2.3 mmol/mol (0.2%) from a baseline of 66 mmol/mol (8.1%) in patients treated with placebo (between‐group difference 7 mmol/mol [0.7%], P &lt; 0.001). Liraglutide reduced total insulin dose by 8 units/day or 16% of total insulin dose (P = 0.008). Mean body weight was reduced by 6.3 kg (P &lt; 0.001) compared with placebo. Concomitantly, time spent in glycaemic target range 4–10 mmol/L (71–180 mg/dL) increased while the risk of hypoglycaemia did not differ between groups at the end of treatment. Conclusion Liraglutide treatment reduced HbA1c, total daily insulin dose and body weight without increasing the risk of hypoglycaemia in CSII‐treated patients with type 1 diabetes and insufficient glycaemic control. Liraglutide may be considered a potential add‐on therapy to insulin in this subgroup of patients.</description><subject>Antidiabetics</subject><subject>Body weight</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes mellitus (insulin dependent)</subject><subject>Drug therapy</subject><subject>GLP-1 receptor agonists</subject><subject>Glucagon</subject><subject>Hemoglobin</subject><subject>Hyperglycemia</subject><subject>Hypoglycemia</subject><subject>Insulin</subject><subject>Obesity</subject><subject>Overweight</subject><subject>Weight control</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp1kc1u1DAQxyMEoqVw4AWQJS4gkdaOE2fdGyqf0qJyKOfIiSe7rpw4-INVOPUROPBu3PskzG4KByR8GXv8m_9_NJNlTxk9ZXjOtBtOGZeM3cuOWSl4zngh7h_uRb6StDjKHoVwTSkt-ap-mB1xJqSo5Oo4-7U2Xm1sikYD8aBTB4Fs5wn8xs6dgsEookZNWqdnsgOz2UZiRuK-gV9er4ieg4dNsiqCxr-QrBlvb35MaZgwRA-Hj0lFA2MMZGfilkR0IIxoo1qIEM7J1RbIvhXyGctI9EbZ25ufing0d4P5DhqNXGotoGaLDnqfmazqoHWY6twYvbMWnQ7Fj7MHvbIBntzFk-zLu7dXFx_y9eX7jxev13nHK85ysZJaFaBZp-u-7CvVs76CmkLfKuhly0SvpGJlLXUhykoy0LUQAiTWqJrX_CR7sehO3n1NEGIzmNCBtWoEl0JTcFasKEcFRJ__g1675EfsDqma1iWtKobUy4XqvAs42L6ZvBmUnxtGm_22G5xHc9g2ss_uFFM7gP5L_lkvAmcLsDMW5v8rNW8uPy2SvwHMfL6U</recordid><startdate>202004</startdate><enddate>202004</enddate><creator>Dejgaard, Thomas F.</creator><creator>Schmidt, Signe</creator><creator>Frandsen, Christian S.</creator><creator>Vistisen, Dorte</creator><creator>Madsbad, Sten</creator><creator>Andersen, Henrik U.</creator><creator>Nørgaard, Kirsten</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-0097-7052</orcidid><orcidid>https://orcid.org/0000-0002-6968-6675</orcidid></search><sort><creationdate>202004</creationdate><title>Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin‐pump‐treated patients with type 1 diabetes: The Lira Pump trial—a randomized, double‐blinded, placebo‐controlled trial</title><author>Dejgaard, Thomas F. ; Schmidt, Signe ; Frandsen, Christian S. ; Vistisen, Dorte ; Madsbad, Sten ; Andersen, Henrik U. ; Nørgaard, Kirsten</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3531-689da2ed1cd7f4f5af1f5e70efbaef9b16fa9a1479d264591ed7666e92eda7373</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Antidiabetics</topic><topic>Body weight</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes mellitus (insulin dependent)</topic><topic>Drug therapy</topic><topic>GLP-1 receptor agonists</topic><topic>Glucagon</topic><topic>Hemoglobin</topic><topic>Hyperglycemia</topic><topic>Hypoglycemia</topic><topic>Insulin</topic><topic>Obesity</topic><topic>Overweight</topic><topic>Weight control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dejgaard, Thomas F.</creatorcontrib><creatorcontrib>Schmidt, Signe</creatorcontrib><creatorcontrib>Frandsen, Christian S.</creatorcontrib><creatorcontrib>Vistisen, Dorte</creatorcontrib><creatorcontrib>Madsbad, Sten</creatorcontrib><creatorcontrib>Andersen, Henrik U.</creatorcontrib><creatorcontrib>Nørgaard, Kirsten</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes, obesity &amp; metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dejgaard, Thomas F.</au><au>Schmidt, Signe</au><au>Frandsen, Christian S.</au><au>Vistisen, Dorte</au><au>Madsbad, Sten</au><au>Andersen, Henrik U.</au><au>Nørgaard, Kirsten</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin‐pump‐treated patients with type 1 diabetes: The Lira Pump trial—a randomized, double‐blinded, placebo‐controlled trial</atitle><jtitle>Diabetes, obesity &amp; metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2020-04</date><risdate>2020</risdate><volume>22</volume><issue>4</issue><spage>492</spage><epage>500</epage><pages>492-500</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><abstract>Aim To investigate the efficacy of adding the glucagon‐like peptide‐1 receptor agonist liraglutide to continuous subcutaneous insulin infusion (CSII) in overweight or obese persons with type 1 diabetes and non‐optimal glycaemic control. Materials and methods A 26‐week, randomized, double‐blind, placebo‐controlled trial including 44 overweight or obese adults with type 1 diabetes randomized 1:1 to liraglutide 1.8 mg once daily (QD) or placebo added to CSII treatment. The primary endpoint was change in haemoglobin A1c (HbA1c). Secondary endpoints included change in insulin dose, CSII settings, glycaemic variability, body weight and patient‐reported outcome measures. Finally, adverse effects including hypoglycaemic events were registered. Results HbA1c was reduced by 5 mmol/mol (0.5%) from a baseline of 66 mmol/mol (8.2%) in patients treated with liraglutide compared with a non‐significant change of +2.3 mmol/mol (0.2%) from a baseline of 66 mmol/mol (8.1%) in patients treated with placebo (between‐group difference 7 mmol/mol [0.7%], P &lt; 0.001). Liraglutide reduced total insulin dose by 8 units/day or 16% of total insulin dose (P = 0.008). Mean body weight was reduced by 6.3 kg (P &lt; 0.001) compared with placebo. Concomitantly, time spent in glycaemic target range 4–10 mmol/L (71–180 mg/dL) increased while the risk of hypoglycaemia did not differ between groups at the end of treatment. Conclusion Liraglutide treatment reduced HbA1c, total daily insulin dose and body weight without increasing the risk of hypoglycaemia in CSII‐treated patients with type 1 diabetes and insufficient glycaemic control. Liraglutide may be considered a potential add‐on therapy to insulin in this subgroup of patients.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>31696598</pmid><doi>10.1111/dom.13911</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-0097-7052</orcidid><orcidid>https://orcid.org/0000-0002-6968-6675</orcidid></addata></record>
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source Wiley-Blackwell Read & Publish Collection
subjects Antidiabetics
Body weight
Clinical trials
Diabetes
Diabetes mellitus (insulin dependent)
Drug therapy
GLP-1 receptor agonists
Glucagon
Hemoglobin
Hyperglycemia
Hypoglycemia
Insulin
Obesity
Overweight
Weight control
title Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin‐pump‐treated patients with type 1 diabetes: The Lira Pump trial—a randomized, double‐blinded, placebo‐controlled trial
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