Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes
Aims To examine whether insulin glargine can lead to better control of glycated haemoglobin (HbA1c) than that achieved by neutral protamine Hagedorn (NPH) insulin, using a protocol designed to limit nocturnal hypoglycaemia. Methods The present study, the Least One Oral Antidiabetic Drug Treatment (L...
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| Veröffentlicht in: | Diabetes, obesity & metabolism obesity & metabolism, 2015-01, Vol.17 (1), p.15-22 |
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| creator | Home, P. D. Bolli, G. B. Mathieu, C. Deerochanawong, C. Landgraf, W. Candelas, C. Pilorget, V. Dain, M.-P. Riddle, M. C. |
| description | Aims
To examine whether insulin glargine can lead to better control of glycated haemoglobin (HbA1c) than that achieved by neutral protamine Hagedorn (NPH) insulin, using a protocol designed to limit nocturnal hypoglycaemia.
Methods
The present study, the Least One Oral Antidiabetic Drug Treatment (LANCELOT) Study, was a 36‐week, randomized, open‐label, parallel‐arm study conducted in Europe, Asia, the Middle East and South America. Participants were randomized (1 : 1) to begin glargine or NPH, on background of metformin with glimepiride. Weekly insulin titration aimed to achieve median prebreakfast and nocturnal plasma glucose levels ≤5.5 mmol/l, while limiting values ≤4.4 mmol/l.
Results
The efficacy population (n = 701) had a mean age of 57 years, a mean body mass index of 29.8 kg/m2, a mean duration of diabetes of 9.2 years and a mean HbA1c level of 8.2% (66 mmol/mol). At treatment end, HbA1c values and the proportion of participants with HbA1c |
| doi_str_mv | 10.1111/dom.12329 |
| format | Article |
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To examine whether insulin glargine can lead to better control of glycated haemoglobin (HbA1c) than that achieved by neutral protamine Hagedorn (NPH) insulin, using a protocol designed to limit nocturnal hypoglycaemia.
Methods
The present study, the Least One Oral Antidiabetic Drug Treatment (LANCELOT) Study, was a 36‐week, randomized, open‐label, parallel‐arm study conducted in Europe, Asia, the Middle East and South America. Participants were randomized (1 : 1) to begin glargine or NPH, on background of metformin with glimepiride. Weekly insulin titration aimed to achieve median prebreakfast and nocturnal plasma glucose levels ≤5.5 mmol/l, while limiting values ≤4.4 mmol/l.
Results
The efficacy population (n = 701) had a mean age of 57 years, a mean body mass index of 29.8 kg/m2, a mean duration of diabetes of 9.2 years and a mean HbA1c level of 8.2% (66 mmol/mol). At treatment end, HbA1c values and the proportion of participants with HbA1c <7.0 % (<53 mmol/mol) were not significantly different for glargine [7.1 % (54 mmol/mol) and 50.3%] versus NPH [7.2 % (55 mmol/mol) and 44.3%]. The rate of symptomatic nocturnal hypoglycaemia, confirmed by plasma glucose ≤3.9 or ≤3.1 mmol/l, was 29 and 48% less with glargine than with NPH insulin. Other outcomes were similar between the groups.
Conclusion
Insulin glargine was not superior to NPH insulin in improving glycaemic control. The insulin dosing algorithm was not sufficient to equalize nocturnal hypoglycaemia between the two insulins. This study confirms, in a globally heterogeneous population, the reduction achieved in nocturnal hypoglycaemia while attaining good glycaemic control with insulin glargine compared with NPH, even when titrating basal insulin to prevent nocturnal hypoglycaemia rather than treating according to normal fasting glucose levels.</description><identifier>ISSN: 1462-8902</identifier><identifier>EISSN: 1463-1326</identifier><identifier>DOI: 10.1111/dom.12329</identifier><identifier>PMID: 24957785</identifier><identifier>CODEN: DOMEF6</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Aged ; Algorithms ; Asia ; Blood Glucose Self-Monitoring ; Body mass index ; Circadian Rhythm ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Dosage ; Drug Dosage Calculations ; Drug Resistance ; Drug Therapy, Combination - adverse effects ; Europe ; Female ; Glucose ; Glycated Hemoglobin A - analysis ; Hemoglobin ; Humans ; Hyperglycemia - prevention & control ; hypoglycaemia-sensitive algorithm ; Hypoglycemia ; Hypoglycemia - chemically induced ; Hypoglycemia - prevention & control ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Insulin ; Insulin Glargine ; Insulin, Isophane - administration & dosage ; Insulin, Isophane - adverse effects ; Insulin, Isophane - therapeutic use ; Insulin, Long-Acting - administration & dosage ; Insulin, Long-Acting - adverse effects ; Insulin, Long-Acting - therapeutic use ; Male ; Metformin ; Metformin - therapeutic use ; Middle Aged ; Middle East ; NPH insulin ; Original ; Protamine ; Protamine sulfate ; South Africa ; Sulfonylurea Compounds - therapeutic use ; Titration</subject><ispartof>Diabetes, obesity & metabolism, 2015-01, Vol.17 (1), p.15-22</ispartof><rights>2014 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.</rights><rights>2015 John Wiley & Sons Ltd</rights><rights>2014. This article is published under http://creativecommons.org/licenses/by-nc-nd/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2014 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5799-e6ea78a69a39c6764e2d47caead9b952ab9100f006ab9bf0c760edda1ba586873</citedby><cites>FETCH-LOGICAL-c5799-e6ea78a69a39c6764e2d47caead9b952ab9100f006ab9bf0c760edda1ba586873</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fdom.12329$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fdom.12329$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,1416,27922,27923,45572,45573</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24957785$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Home, P. D.</creatorcontrib><creatorcontrib>Bolli, G. B.</creatorcontrib><creatorcontrib>Mathieu, C.</creatorcontrib><creatorcontrib>Deerochanawong, C.</creatorcontrib><creatorcontrib>Landgraf, W.</creatorcontrib><creatorcontrib>Candelas, C.</creatorcontrib><creatorcontrib>Pilorget, V.</creatorcontrib><creatorcontrib>Dain, M.-P.</creatorcontrib><creatorcontrib>Riddle, M. C.</creatorcontrib><title>Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes</title><title>Diabetes, obesity & metabolism</title><addtitle>Diabetes Obes Metab</addtitle><description>Aims
To examine whether insulin glargine can lead to better control of glycated haemoglobin (HbA1c) than that achieved by neutral protamine Hagedorn (NPH) insulin, using a protocol designed to limit nocturnal hypoglycaemia.
Methods
The present study, the Least One Oral Antidiabetic Drug Treatment (LANCELOT) Study, was a 36‐week, randomized, open‐label, parallel‐arm study conducted in Europe, Asia, the Middle East and South America. Participants were randomized (1 : 1) to begin glargine or NPH, on background of metformin with glimepiride. Weekly insulin titration aimed to achieve median prebreakfast and nocturnal plasma glucose levels ≤5.5 mmol/l, while limiting values ≤4.4 mmol/l.
Results
The efficacy population (n = 701) had a mean age of 57 years, a mean body mass index of 29.8 kg/m2, a mean duration of diabetes of 9.2 years and a mean HbA1c level of 8.2% (66 mmol/mol). At treatment end, HbA1c values and the proportion of participants with HbA1c <7.0 % (<53 mmol/mol) were not significantly different for glargine [7.1 % (54 mmol/mol) and 50.3%] versus NPH [7.2 % (55 mmol/mol) and 44.3%]. The rate of symptomatic nocturnal hypoglycaemia, confirmed by plasma glucose ≤3.9 or ≤3.1 mmol/l, was 29 and 48% less with glargine than with NPH insulin. Other outcomes were similar between the groups.
Conclusion
Insulin glargine was not superior to NPH insulin in improving glycaemic control. The insulin dosing algorithm was not sufficient to equalize nocturnal hypoglycaemia between the two insulins. This study confirms, in a globally heterogeneous population, the reduction achieved in nocturnal hypoglycaemia while attaining good glycaemic control with insulin glargine compared with NPH, even when titrating basal insulin to prevent nocturnal hypoglycaemia rather than treating according to normal fasting glucose levels.</description><subject>Aged</subject><subject>Algorithms</subject><subject>Asia</subject><subject>Blood Glucose Self-Monitoring</subject><subject>Body mass index</subject><subject>Circadian Rhythm</subject><subject>Diabetes</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Dosage</subject><subject>Drug Dosage Calculations</subject><subject>Drug Resistance</subject><subject>Drug Therapy, Combination - adverse effects</subject><subject>Europe</subject><subject>Female</subject><subject>Glucose</subject><subject>Glycated Hemoglobin A - analysis</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hyperglycemia - prevention & control</subject><subject>hypoglycaemia-sensitive algorithm</subject><subject>Hypoglycemia</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemia - prevention & control</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin</subject><subject>Insulin Glargine</subject><subject>Insulin, Isophane - administration & dosage</subject><subject>Insulin, Isophane - adverse effects</subject><subject>Insulin, Isophane - therapeutic use</subject><subject>Insulin, Long-Acting - administration & dosage</subject><subject>Insulin, Long-Acting - adverse effects</subject><subject>Insulin, Long-Acting - therapeutic use</subject><subject>Male</subject><subject>Metformin</subject><subject>Metformin - therapeutic use</subject><subject>Middle Aged</subject><subject>Middle East</subject><subject>NPH insulin</subject><subject>Original</subject><subject>Protamine</subject><subject>Protamine sulfate</subject><subject>South Africa</subject><subject>Sulfonylurea Compounds - therapeutic use</subject><subject>Titration</subject><issn>1462-8902</issn><issn>1463-1326</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp9ksFu1DAQQCMEoqVw4AeQJU4c0jp2YscckMoCXaSWSqjA0Zoks6lLYgc72bJfxZU7P4a320ZwAEuWR5o3TzPyJMnTjB5m8Rw1rj_MGGfqXrKf5YKnGWfi_k3M0lJRtpc8CuGKUprzUj5M9liuCinLYj_5eeaaqYPROEvcihgbps5Y0riAZDSj32WmYGxLgFxuBtd2mxqwN5AGtMGMZo0EutZ5M172L2dD24FvjUWyRh-mQCxO0daRwbsR-m1iCS02ztu5xMxhauHXj-gd0A0dkuuoJuNmQMJIY6DCEcPj5MEKuoBPbt-D5NO7txeLZXp6fvJ-cXya1oVUKkWBIEsQCriqhRQ5siaXcQBoVKUKBpXKKF1RKmJUrWgtBcWmgayCohSl5AfJq513mKoemxrtdgw9eNOD32gHRv-dseZSt26tc1YyWWRR8PxW4N23CcOor9zkbexZc1qoPP4FL_9HZYLnXORlySL1YkfV3oXgcTX3kVG9XQUdV0HfrEJkn_3Z-Eze_X0EjnbAtelw82-TfnN-dqdMdxUmjPh9rgD_VQvJZaG_fDiJd7n4-PrzhS74bz651Cg</recordid><startdate>201501</startdate><enddate>201501</enddate><creator>Home, P. D.</creator><creator>Bolli, G. B.</creator><creator>Mathieu, C.</creator><creator>Deerochanawong, C.</creator><creator>Landgraf, W.</creator><creator>Candelas, C.</creator><creator>Pilorget, V.</creator><creator>Dain, M.-P.</creator><creator>Riddle, M. C.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>24P</scope><scope>WIN</scope><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>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>5PM</scope></search><sort><creationdate>201501</creationdate><title>Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes</title><author>Home, P. D. ; Bolli, G. B. ; Mathieu, C. ; Deerochanawong, C. ; Landgraf, W. ; Candelas, C. ; Pilorget, V. ; Dain, M.-P. ; Riddle, M. C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5799-e6ea78a69a39c6764e2d47caead9b952ab9100f006ab9bf0c760edda1ba586873</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Aged</topic><topic>Algorithms</topic><topic>Asia</topic><topic>Blood Glucose Self-Monitoring</topic><topic>Body mass index</topic><topic>Circadian Rhythm</topic><topic>Diabetes</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Dosage</topic><topic>Drug Dosage Calculations</topic><topic>Drug Resistance</topic><topic>Drug Therapy, Combination - adverse effects</topic><topic>Europe</topic><topic>Female</topic><topic>Glucose</topic><topic>Glycated Hemoglobin A - analysis</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hyperglycemia - prevention & control</topic><topic>hypoglycaemia-sensitive algorithm</topic><topic>Hypoglycemia</topic><topic>Hypoglycemia - chemically induced</topic><topic>Hypoglycemia - prevention & control</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Insulin</topic><topic>Insulin Glargine</topic><topic>Insulin, Isophane - administration & dosage</topic><topic>Insulin, Isophane - adverse effects</topic><topic>Insulin, Isophane - therapeutic use</topic><topic>Insulin, Long-Acting - administration & dosage</topic><topic>Insulin, Long-Acting - adverse effects</topic><topic>Insulin, Long-Acting - therapeutic use</topic><topic>Male</topic><topic>Metformin</topic><topic>Metformin - therapeutic use</topic><topic>Middle Aged</topic><topic>Middle East</topic><topic>NPH insulin</topic><topic>Original</topic><topic>Protamine</topic><topic>Protamine sulfate</topic><topic>South Africa</topic><topic>Sulfonylurea Compounds - therapeutic use</topic><topic>Titration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Home, P. D.</creatorcontrib><creatorcontrib>Bolli, G. B.</creatorcontrib><creatorcontrib>Mathieu, C.</creatorcontrib><creatorcontrib>Deerochanawong, C.</creatorcontrib><creatorcontrib>Landgraf, W.</creatorcontrib><creatorcontrib>Candelas, C.</creatorcontrib><creatorcontrib>Pilorget, V.</creatorcontrib><creatorcontrib>Dain, M.-P.</creatorcontrib><creatorcontrib>Riddle, M. C.</creatorcontrib><collection>Istex</collection><collection>Wiley-Blackwell Open Access Titles</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetes, obesity & metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Home, P. D.</au><au>Bolli, G. B.</au><au>Mathieu, C.</au><au>Deerochanawong, C.</au><au>Landgraf, W.</au><au>Candelas, C.</au><au>Pilorget, V.</au><au>Dain, M.-P.</au><au>Riddle, M. C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes</atitle><jtitle>Diabetes, obesity & metabolism</jtitle><addtitle>Diabetes Obes Metab</addtitle><date>2015-01</date><risdate>2015</risdate><volume>17</volume><issue>1</issue><spage>15</spage><epage>22</epage><pages>15-22</pages><issn>1462-8902</issn><eissn>1463-1326</eissn><coden>DOMEF6</coden><abstract>Aims
To examine whether insulin glargine can lead to better control of glycated haemoglobin (HbA1c) than that achieved by neutral protamine Hagedorn (NPH) insulin, using a protocol designed to limit nocturnal hypoglycaemia.
Methods
The present study, the Least One Oral Antidiabetic Drug Treatment (LANCELOT) Study, was a 36‐week, randomized, open‐label, parallel‐arm study conducted in Europe, Asia, the Middle East and South America. Participants were randomized (1 : 1) to begin glargine or NPH, on background of metformin with glimepiride. Weekly insulin titration aimed to achieve median prebreakfast and nocturnal plasma glucose levels ≤5.5 mmol/l, while limiting values ≤4.4 mmol/l.
Results
The efficacy population (n = 701) had a mean age of 57 years, a mean body mass index of 29.8 kg/m2, a mean duration of diabetes of 9.2 years and a mean HbA1c level of 8.2% (66 mmol/mol). At treatment end, HbA1c values and the proportion of participants with HbA1c <7.0 % (<53 mmol/mol) were not significantly different for glargine [7.1 % (54 mmol/mol) and 50.3%] versus NPH [7.2 % (55 mmol/mol) and 44.3%]. The rate of symptomatic nocturnal hypoglycaemia, confirmed by plasma glucose ≤3.9 or ≤3.1 mmol/l, was 29 and 48% less with glargine than with NPH insulin. Other outcomes were similar between the groups.
Conclusion
Insulin glargine was not superior to NPH insulin in improving glycaemic control. The insulin dosing algorithm was not sufficient to equalize nocturnal hypoglycaemia between the two insulins. This study confirms, in a globally heterogeneous population, the reduction achieved in nocturnal hypoglycaemia while attaining good glycaemic control with insulin glargine compared with NPH, even when titrating basal insulin to prevent nocturnal hypoglycaemia rather than treating according to normal fasting glucose levels.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>24957785</pmid><doi>10.1111/dom.12329</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Algorithms Asia Blood Glucose Self-Monitoring Body mass index Circadian Rhythm Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Dosage Drug Dosage Calculations Drug Resistance Drug Therapy, Combination - adverse effects Europe Female Glucose Glycated Hemoglobin A - analysis Hemoglobin Humans Hyperglycemia - prevention & control hypoglycaemia-sensitive algorithm Hypoglycemia Hypoglycemia - chemically induced Hypoglycemia - prevention & control Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Insulin Insulin Glargine Insulin, Isophane - administration & dosage Insulin, Isophane - adverse effects Insulin, Isophane - therapeutic use Insulin, Long-Acting - administration & dosage Insulin, Long-Acting - adverse effects Insulin, Long-Acting - therapeutic use Male Metformin Metformin - therapeutic use Middle Aged Middle East NPH insulin Original Protamine Protamine sulfate South Africa Sulfonylurea Compounds - therapeutic use Titration |
| title | Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes |
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