24-Week, Randomized, Treat-to-Target Trial Comparing Initiation of Insulin Glargine Once-Daily With Insulin Detemir Twice-Daily in Patients With Type 2 Diabetes Inadequately Controlled on Oral Glucose-Lowering Drugs

OBJECTIVE: To determine whether glargine is noninferior to detemir regarding the percentage of patients reaching A1C

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Veröffentlicht in:Diabetes care 2010-06, Vol.33 (6), p.1176-1178
Hauptverfasser: Swinnen, Sanne G, Dain, Marie-Paule, Aronson, Ronnie, Davies, Melanie, Gerstein, Hertzel C, Pfeiffer, Andreas F, Snoek, Frank J, DeVries, J. Hans, Hoekstra, Joost B, Holleman, Frits
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container_end_page 1178
container_issue 6
container_start_page 1176
container_title Diabetes care
container_volume 33
creator Swinnen, Sanne G
Dain, Marie-Paule
Aronson, Ronnie
Davies, Melanie
Gerstein, Hertzel C
Pfeiffer, Andreas F
Snoek, Frank J
DeVries, J. Hans
Hoekstra, Joost B
Holleman, Frits
description OBJECTIVE: To determine whether glargine is noninferior to detemir regarding the percentage of patients reaching A1C
doi_str_mv 10.2337/dc09-2294
format Article
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Hans ; Hoekstra, Joost B ; Holleman, Frits</creator><creatorcontrib>Swinnen, Sanne G ; Dain, Marie-Paule ; Aronson, Ronnie ; Davies, Melanie ; Gerstein, Hertzel C ; Pfeiffer, Andreas F ; Snoek, Frank J ; DeVries, J. Hans ; Hoekstra, Joost B ; Holleman, Frits</creatorcontrib><description>OBJECTIVE: To determine whether glargine is noninferior to detemir regarding the percentage of patients reaching A1C &lt;7% without symptomatic hypoglycemia [less-than or equal to]3.1 mmol/l. RESEARCH DESIGN AND METHODS: In this 24-week trial, 973 insulin-naive type 2 diabetic patients on stable oral glucose-lowering drugs with A1C 7.0-10.5% were randomized to glargine once daily or detemir twice daily. Insulin doses were systematically titrated. RESULTS: 27.5 and 25.6% of patients reached the primary outcome with glargine and detemir, respectively, demonstrating the noninferiority of glargine. Improvements in A1C were -1.46 ± 1.09% for glargine and -1.54 ± 1.11% for detemir (P = 0.149), with similar proportions of patients achieving A1C &lt;7% (P = 0.254) but more detemir-treated patients reaching A1C &lt;6.5% (P = 0.017). Hypoglycemia risk was similar. Weight gain was higher for glargine (difference: 0.77 kg, P &lt; 0.001). Glargine doses were lower than detemir doses: 43.5 ± 29.0 vs. 76.5 ± 50.5 units/day (P &lt; 0.001). CONCLUSIONS: In insulin-naive type 2 diabetic patients, glargine reached similar control as detemir, with more weight gain, but required significantly lower doses.</description><identifier>ISSN: 0149-5992</identifier><identifier>EISSN: 1935-5548</identifier><identifier>DOI: 10.2337/dc09-2294</identifier><identifier>PMID: 20200301</identifier><identifier>CODEN: DICAD2</identifier><language>eng</language><publisher>Alexandria, VA: American Diabetes Association</publisher><subject>Administration, Oral ; Biological and medical sciences ; Clinical trials ; Comparative analysis ; Diabetes ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - metabolism ; Diabetes. Impaired glucose tolerance ; Dosage and administration ; Drug Administration Schedule ; Drug therapy ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Glycated Hemoglobin A - metabolism ; Humans ; Hypoglycemic Agents - administration &amp; dosage ; Hypoglycemic Agents - pharmacology ; Insulin - administration &amp; dosage ; Insulin - analogs &amp; derivatives ; Insulin - pharmacology ; Insulin - therapeutic use ; Insulin Detemir ; Insulin Glargine ; Insulin, Long-Acting ; Medical sciences ; Metabolic diseases ; Miscellaneous ; Original Research ; Patient outcomes ; Public health. Hygiene ; Public health. 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Hans</creatorcontrib><creatorcontrib>Hoekstra, Joost B</creatorcontrib><creatorcontrib>Holleman, Frits</creatorcontrib><title>24-Week, Randomized, Treat-to-Target Trial Comparing Initiation of Insulin Glargine Once-Daily With Insulin Detemir Twice-Daily in Patients With Type 2 Diabetes Inadequately Controlled on Oral Glucose-Lowering Drugs</title><title>Diabetes care</title><addtitle>Diabetes Care</addtitle><description>OBJECTIVE: To determine whether glargine is noninferior to detemir regarding the percentage of patients reaching A1C &lt;7% without symptomatic hypoglycemia [less-than or equal to]3.1 mmol/l. RESEARCH DESIGN AND METHODS: In this 24-week trial, 973 insulin-naive type 2 diabetic patients on stable oral glucose-lowering drugs with A1C 7.0-10.5% were randomized to glargine once daily or detemir twice daily. Insulin doses were systematically titrated. RESULTS: 27.5 and 25.6% of patients reached the primary outcome with glargine and detemir, respectively, demonstrating the noninferiority of glargine. Improvements in A1C were -1.46 ± 1.09% for glargine and -1.54 ± 1.11% for detemir (P = 0.149), with similar proportions of patients achieving A1C &lt;7% (P = 0.254) but more detemir-treated patients reaching A1C &lt;6.5% (P = 0.017). Hypoglycemia risk was similar. Weight gain was higher for glargine (difference: 0.77 kg, P &lt; 0.001). Glargine doses were lower than detemir doses: 43.5 ± 29.0 vs. 76.5 ± 50.5 units/day (P &lt; 0.001). CONCLUSIONS: In insulin-naive type 2 diabetic patients, glargine reached similar control as detemir, with more weight gain, but required significantly lower doses.</description><subject>Administration, Oral</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Comparative analysis</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - metabolism</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Dosage and administration</subject><subject>Drug Administration Schedule</subject><subject>Drug therapy</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Etiopathogenesis. Screening. Investigations. Target tissue resistance</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Humans</subject><subject>Hypoglycemic Agents - administration &amp; dosage</subject><subject>Hypoglycemic Agents - pharmacology</subject><subject>Insulin - administration &amp; dosage</subject><subject>Insulin - analogs &amp; derivatives</subject><subject>Insulin - pharmacology</subject><subject>Insulin - therapeutic use</subject><subject>Insulin Detemir</subject><subject>Insulin Glargine</subject><subject>Insulin, Long-Acting</subject><subject>Medical sciences</subject><subject>Metabolic diseases</subject><subject>Miscellaneous</subject><subject>Original Research</subject><subject>Patient outcomes</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Quality of life</subject><subject>Studies</subject><subject>Treatment Outcome</subject><subject>Type 2 diabetes</subject><subject>Weight Gain - drug effects</subject><issn>0149-5992</issn><issn>1935-5548</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNpt0lFv0zAQAOAIgdgoPPAHIBpCCGkZjmM38QvS1EKZVKkIOu3Rcp1L5pHYnZ0wlT_K3-FCS2GoykNk-_P5fL4oep6SM5pl-btSE5FQKtiD6DgVGU84Z8XD6JikTCRcCHoUPQnhhhDCWFE8jo4ooYRkJD2OflKWXAF8O42_KFu61vyA8jReelBd0rlkqXwNHY6NauKJa9fKG1vHF9Z0RnXG2dhVOAp9Y2w8a1AbC_HCakimyjSb-Mp013swhQ5a4-PlndkDnP6MkcB2YYuXmzXENJ4atUIecLMq4bZXHaCeONt51zRQxnj2wmNWs6bXLkAyd3fwO7mp7-vwNHpUqSbAs91_FF1-_LCcfErmi9nF5HyeaD4mXVKlfCwKIJpqTqjgLCNYGl5wlTPKCSiiyxKyjFe6XDGiBIMUskIQpDxneTaK3m_jrvtVC6XGe2BScu1Nq_xGOmXk_RVrrmXtvkta5JzhY42iN7sA3t32EDrZmqChaZQF1weZZ1lKxuMiRXnyn7xxvbd4OzlGgZ1AhnCvtqhWDUhjK4en6iGkPKcUE8drDyo5oGqwgCk6C5XB6Xv-7IDHr8T31Ac3vN1u0N6F4KHaVyQlcuhZOfSsHHoW7Yt_S7iXf5oUwesdUEGrpvLKahP-OixlIThH93LrKuWkqj2ay68UA5C0YLnAYv8C2Bn8vA</recordid><startdate>20100601</startdate><enddate>20100601</enddate><creator>Swinnen, Sanne G</creator><creator>Dain, Marie-Paule</creator><creator>Aronson, Ronnie</creator><creator>Davies, Melanie</creator><creator>Gerstein, Hertzel C</creator><creator>Pfeiffer, Andreas F</creator><creator>Snoek, Frank J</creator><creator>DeVries, J. 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Hans</au><au>Hoekstra, Joost B</au><au>Holleman, Frits</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>24-Week, Randomized, Treat-to-Target Trial Comparing Initiation of Insulin Glargine Once-Daily With Insulin Detemir Twice-Daily in Patients With Type 2 Diabetes Inadequately Controlled on Oral Glucose-Lowering Drugs</atitle><jtitle>Diabetes care</jtitle><addtitle>Diabetes Care</addtitle><date>2010-06-01</date><risdate>2010</risdate><volume>33</volume><issue>6</issue><spage>1176</spage><epage>1178</epage><pages>1176-1178</pages><issn>0149-5992</issn><eissn>1935-5548</eissn><coden>DICAD2</coden><abstract>OBJECTIVE: To determine whether glargine is noninferior to detemir regarding the percentage of patients reaching A1C &lt;7% without symptomatic hypoglycemia [less-than or equal to]3.1 mmol/l. RESEARCH DESIGN AND METHODS: In this 24-week trial, 973 insulin-naive type 2 diabetic patients on stable oral glucose-lowering drugs with A1C 7.0-10.5% were randomized to glargine once daily or detemir twice daily. Insulin doses were systematically titrated. RESULTS: 27.5 and 25.6% of patients reached the primary outcome with glargine and detemir, respectively, demonstrating the noninferiority of glargine. Improvements in A1C were -1.46 ± 1.09% for glargine and -1.54 ± 1.11% for detemir (P = 0.149), with similar proportions of patients achieving A1C &lt;7% (P = 0.254) but more detemir-treated patients reaching A1C &lt;6.5% (P = 0.017). Hypoglycemia risk was similar. Weight gain was higher for glargine (difference: 0.77 kg, P &lt; 0.001). Glargine doses were lower than detemir doses: 43.5 ± 29.0 vs. 76.5 ± 50.5 units/day (P &lt; 0.001). CONCLUSIONS: In insulin-naive type 2 diabetic patients, glargine reached similar control as detemir, with more weight gain, but required significantly lower doses.</abstract><cop>Alexandria, VA</cop><pub>American Diabetes Association</pub><pmid>20200301</pmid><doi>10.2337/dc09-2294</doi><tpages>3</tpages><oa>free_for_read</oa></addata></record>
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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
subjects Administration, Oral
Biological and medical sciences
Clinical trials
Comparative analysis
Diabetes
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - metabolism
Diabetes. Impaired glucose tolerance
Dosage and administration
Drug Administration Schedule
Drug therapy
Endocrine pancreas. Apud cells (diseases)
Endocrinopathies
Etiopathogenesis. Screening. Investigations. Target tissue resistance
Glycated Hemoglobin A - metabolism
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - pharmacology
Insulin - administration & dosage
Insulin - analogs & derivatives
Insulin - pharmacology
Insulin - therapeutic use
Insulin Detemir
Insulin Glargine
Insulin, Long-Acting
Medical sciences
Metabolic diseases
Miscellaneous
Original Research
Patient outcomes
Public health. Hygiene
Public health. Hygiene-occupational medicine
Quality of life
Studies
Treatment Outcome
Type 2 diabetes
Weight Gain - drug effects
title 24-Week, Randomized, Treat-to-Target Trial Comparing Initiation of Insulin Glargine Once-Daily With Insulin Detemir Twice-Daily in Patients With Type 2 Diabetes Inadequately Controlled on Oral Glucose-Lowering Drugs
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