Glycemia reduction in type 2 diabetes-Hypoglycemia outcomes: A randomized clinical trial
Hypoglycemia is a major concern in type 2 diabetes (T2DM), but little is known about its likelihood compared across common therapies. We compared the likelihood of hypoglycemia among metformin-treated patients with T2DM randomized to the addition of one of 4 common therapies. Randomized, controlled...
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| Veröffentlicht in: | PloS one 2024-11, Vol.19 (11), p.e0309907 |
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| creator | Seaquist, Elizabeth R Phillips, Lawrence S Ghosh, Alokananda Baker, Chelsea Bergenstal, Richard M Crandall, Jill P Goland, Robin S Gramzinski, Michaela R Hox, Sophia H Hsia, Daniel S Johnson, Mary L Lachin, John M Raskin, Philip Valencia, Willy M Waltje, Andrea H Younes, Naji |
| description | Hypoglycemia is a major concern in type 2 diabetes (T2DM), but little is known about its likelihood compared across common therapies. We compared the likelihood of hypoglycemia among metformin-treated patients with T2DM randomized to the addition of one of 4 common therapies.
Randomized, controlled trial of 5,047 participants with T2DM of |
| doi_str_mv | 10.1371/journal.pone.0309907 |
| format | Article |
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Randomized, controlled trial of 5,047 participants with T2DM of <10 years' duration, hemoglobin A1c (HbA1c) 6.8-8.5% (50.8-69.4 mmol/mol). Randomization to addition of glargine U100, glimepiride, liraglutide, or sitagliptin over 5.0 ± 1.3 (mean ± SD) years. HbA1c was measured quarterly; if a level >7.5% (>58.5 mmol/mol) was confirmed, rescue glargine and/or aspart insulin was added. We conducted a per-protocol analysis of 4,830, who attended at least one post-baseline visit and took at least one dose of assigned study medication. We assessed severe hypoglycemia events reported throughout the entire study. At quarterly visits, all participants were asked about hypoglycemic symptoms within the last 30 days, and those in the glargine and glimepiride groups were asked for any measured glucose <70 mg/dL (3.9 mmol/L) within this time period.
While participants were taking their assigned medications, severe hypoglycemia occurred in 10 (0.8%), 16 (1.3%), 6 (0.5%), and 4 (0.3%), (p<0.05) and hypoglycemic symptoms in 659 (54.2%), 833 (68.3%), 375 (32.4%), and 361 (29.1%) of participants following randomization to glargine, glimepiride, liraglutide, and sitagliptin, respectively (p<0.001).
In metformin-treated patients with T2DM who add a second medication, hypoglycemia is most likely with addition of glimepiride, less with glargine, and least likely with liraglutide and sitagliptin.
ClinicalTrials.gov Identifier: NCT01794143.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0309907</identifier><identifier>PMID: 39546502</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Aged ; Blood glucose ; Blood Glucose - analysis ; Blood Glucose - drug effects ; Body mass index ; Complications and side effects ; Development and progression ; Diabetes ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Diagnosis ; Drug dosages ; Drug therapy ; Female ; Glucose ; Glycated Hemoglobin - analysis ; Glycated Hemoglobin - metabolism ; Glycemic Control ; Hemoglobin ; Humans ; Hypoglycemia ; Hypoglycemia - chemically induced ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Insulin ; Insulin Glargine - administration & dosage ; Insulin Glargine - adverse effects ; Insulin Glargine - therapeutic use ; Liraglutide - adverse effects ; Liraglutide - therapeutic use ; Male ; Metformin ; Metformin - adverse effects ; Metformin - therapeutic use ; Middle Aged ; Probability ; Randomization ; Research design ; Review boards ; Risk factors ; Sitagliptin Phosphate - adverse effects ; Sitagliptin Phosphate - therapeutic use ; Sulfonylurea Compounds - adverse effects ; Sulfonylurea Compounds - therapeutic use ; Treatment Outcome ; Type 2 diabetes</subject><ispartof>PloS one, 2024-11, Vol.19 (11), p.e0309907</ispartof><rights>Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. 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We compared the likelihood of hypoglycemia among metformin-treated patients with T2DM randomized to the addition of one of 4 common therapies.
Randomized, controlled trial of 5,047 participants with T2DM of <10 years' duration, hemoglobin A1c (HbA1c) 6.8-8.5% (50.8-69.4 mmol/mol). Randomization to addition of glargine U100, glimepiride, liraglutide, or sitagliptin over 5.0 ± 1.3 (mean ± SD) years. HbA1c was measured quarterly; if a level >7.5% (>58.5 mmol/mol) was confirmed, rescue glargine and/or aspart insulin was added. We conducted a per-protocol analysis of 4,830, who attended at least one post-baseline visit and took at least one dose of assigned study medication. We assessed severe hypoglycemia events reported throughout the entire study. At quarterly visits, all participants were asked about hypoglycemic symptoms within the last 30 days, and those in the glargine and glimepiride groups were asked for any measured glucose <70 mg/dL (3.9 mmol/L) within this time period.
While participants were taking their assigned medications, severe hypoglycemia occurred in 10 (0.8%), 16 (1.3%), 6 (0.5%), and 4 (0.3%), (p<0.05) and hypoglycemic symptoms in 659 (54.2%), 833 (68.3%), 375 (32.4%), and 361 (29.1%) of participants following randomization to glargine, glimepiride, liraglutide, and sitagliptin, respectively (p<0.001).
In metformin-treated patients with T2DM who add a second medication, hypoglycemia is most likely with addition of glimepiride, less with glargine, and least likely with liraglutide and sitagliptin.
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C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</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>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Seaquist, Elizabeth R</au><au>Phillips, Lawrence S</au><au>Ghosh, Alokananda</au><au>Baker, Chelsea</au><au>Bergenstal, Richard M</au><au>Crandall, Jill P</au><au>Goland, Robin S</au><au>Gramzinski, Michaela R</au><au>Hox, Sophia H</au><au>Hsia, Daniel S</au><au>Johnson, Mary L</au><au>Lachin, John M</au><au>Raskin, Philip</au><au>Valencia, Willy M</au><au>Waltje, Andrea H</au><au>Younes, Naji</au><aucorp>GRADE Research Group</aucorp><aucorp>for the GRADE Research Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Glycemia reduction in type 2 diabetes-Hypoglycemia outcomes: A randomized clinical trial</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2024-11-15</date><risdate>2024</risdate><volume>19</volume><issue>11</issue><spage>e0309907</spage><pages>e0309907-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Hypoglycemia is a major concern in type 2 diabetes (T2DM), but little is known about its likelihood compared across common therapies. We compared the likelihood of hypoglycemia among metformin-treated patients with T2DM randomized to the addition of one of 4 common therapies.
Randomized, controlled trial of 5,047 participants with T2DM of <10 years' duration, hemoglobin A1c (HbA1c) 6.8-8.5% (50.8-69.4 mmol/mol). Randomization to addition of glargine U100, glimepiride, liraglutide, or sitagliptin over 5.0 ± 1.3 (mean ± SD) years. HbA1c was measured quarterly; if a level >7.5% (>58.5 mmol/mol) was confirmed, rescue glargine and/or aspart insulin was added. We conducted a per-protocol analysis of 4,830, who attended at least one post-baseline visit and took at least one dose of assigned study medication. We assessed severe hypoglycemia events reported throughout the entire study. At quarterly visits, all participants were asked about hypoglycemic symptoms within the last 30 days, and those in the glargine and glimepiride groups were asked for any measured glucose <70 mg/dL (3.9 mmol/L) within this time period.
While participants were taking their assigned medications, severe hypoglycemia occurred in 10 (0.8%), 16 (1.3%), 6 (0.5%), and 4 (0.3%), (p<0.05) and hypoglycemic symptoms in 659 (54.2%), 833 (68.3%), 375 (32.4%), and 361 (29.1%) of participants following randomization to glargine, glimepiride, liraglutide, and sitagliptin, respectively (p<0.001).
In metformin-treated patients with T2DM who add a second medication, hypoglycemia is most likely with addition of glimepiride, less with glargine, and least likely with liraglutide and sitagliptin.
ClinicalTrials.gov Identifier: NCT01794143.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>39546502</pmid><doi>10.1371/journal.pone.0309907</doi><tpages>e0309907</tpages><orcidid>https://orcid.org/0000-0002-9807-7115</orcidid><orcidid>https://orcid.org/0000-0002-9050-5584</orcidid><orcidid>https://orcid.org/0000-0003-2832-3429</orcidid><orcidid>https://orcid.org/0000-0002-1945-1034</orcidid><orcidid>https://orcid.org/0009-0001-1662-7196</orcidid><orcidid>https://orcid.org/0000-0001-5311-056X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2024-11, Vol.19 (11), p.e0309907 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_3128949504 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Free Full-Text Journals in Chemistry; Public Library of Science (PLoS) |
| subjects | Aged Blood glucose Blood Glucose - analysis Blood Glucose - drug effects Body mass index Complications and side effects Development and progression Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Diagnosis Drug dosages Drug therapy Female Glucose Glycated Hemoglobin - analysis Glycated Hemoglobin - metabolism Glycemic Control Hemoglobin Humans Hypoglycemia Hypoglycemia - chemically induced Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Insulin Insulin Glargine - administration & dosage Insulin Glargine - adverse effects Insulin Glargine - therapeutic use Liraglutide - adverse effects Liraglutide - therapeutic use Male Metformin Metformin - adverse effects Metformin - therapeutic use Middle Aged Probability Randomization Research design Review boards Risk factors Sitagliptin Phosphate - adverse effects Sitagliptin Phosphate - therapeutic use Sulfonylurea Compounds - adverse effects Sulfonylurea Compounds - therapeutic use Treatment Outcome Type 2 diabetes |
| title | Glycemia reduction in type 2 diabetes-Hypoglycemia outcomes: A randomized clinical trial |
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