Safety and Tolerability of the Treatment of Youth-Onset Type 2 Diabetes: The TODAY experience
Data related to the safety and tolerability of treatments for pediatric type 2 diabetes are limited. The TODAY clinical trial assessed severe adverse events (SAEs) and targeted nonsevere adverse events (AEs) before and after treatment failure, which was the primary outcome (PO). Obese 10- to 17-year...
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| Veröffentlicht in: | Diabetes care 2013-06, Vol.36 (6), p.1765-1771 |
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| description | Data related to the safety and tolerability of treatments for pediatric type 2 diabetes are limited. The TODAY clinical trial assessed severe adverse events (SAEs) and targeted nonsevere adverse events (AEs) before and after treatment failure, which was the primary outcome (PO).
Obese 10- to 17-year-olds (N = 699) with type 2 diabetes for |
| doi_str_mv | 10.2337/dc12-2390 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3661822</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A333331014</galeid><sourcerecordid>A333331014</sourcerecordid><originalsourceid>FETCH-LOGICAL-g429t-e657e2d96db931fa761d50afa3e35c72ca976c866eb7caa5ddf742c08cbdda443</originalsourceid><addsrcrecordid>eNptkctu1DAUhi0EotPCghdAkRDLFN-dsEAateUiVZoFYdEFsk7skxlXiTM4GcS8PR4YLpXGXlj6_Z3_3Ah5weglF8K88Y7xkouaPiILVgtVKiWrx2RBmaxLVdf8jJxP0z2lVMqqekrOuDBUaqMX5Otn6HDeFxB90Yw9JmhDH7IwdsW8waJJCPOAcT4Id-Nu3pSrOOFcNPstFry4DtDijNPbojnQq-vlXYE_tpgCRofPyJMO-gmfH98L8uX9TXP1sbxdffh0tbwt15LXc4laGeS-1r6tBevAaOYVhQ4ECuUMd1Ab7SqtsTUOQHnfGckdrVzrPUgpLsi7377bXTugd7neBL3dpjBA2tsRgn34E8PGrsfvVmjNKs6zwaujQRq_7XCa7f24SzHXbJnQqlKs-pXmSK2hRxtiN2YzN4TJ2aU4HJYnnqnyBLXGmIfbjxG7kOUH_OUJPl-PQ3AnA17-3-3fNv9sNQOvjwBMDvouQXRh-scZSZlSWvwEO4mucw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1365851844</pqid></control><display><type>article</type><title>Safety and Tolerability of the Treatment of Youth-Onset Type 2 Diabetes: The TODAY experience</title><source>Journals@Ovid Ovid Autoload</source><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creatorcontrib>TODAY Study Group</creatorcontrib><description>Data related to the safety and tolerability of treatments for pediatric type 2 diabetes are limited. The TODAY clinical trial assessed severe adverse events (SAEs) and targeted nonsevere adverse events (AEs) before and after treatment failure, which was the primary outcome (PO).
Obese 10- to 17-year-olds (N = 699) with type 2 diabetes for <2 years and hemoglobin A1c (A1C) ≤ 8% on metformin monotherapy were randomized to one of three treatments: metformin, metformin plus rosiglitazone (M + R), or metformin plus lifestyle program (M + L). Participants were followed for 2-6.5 years.
Gastrointestinal (GI) disturbance was the most common AE (41%) and was lower in the M + R group (P = 0.018). Other common AEs included anemia (20% before PO, 14% after PO), abnormal liver transaminases (16, 15%), excessive weight gain (7, 9%), and psychological events (10, 18%); the AEs were similar across treatments. Permanent medication reductions/discontinuations occurred most often because of abnormal liver transaminases and were lowest in the M + R group (P = 0.005). Treatment-emergent SAEs were uncommon and similar across treatments. Most (98%) were unrelated or unlikely related to the study intervention. There were no deaths and only 18 targeted SAEs (diabetic ketoacidosis, n = 12; severe hypoglycemia, n = 5; lactic acidosis, n = 1). There were 62 pregnancies occurring in 45 participants, and 6 infants had congenital anomalies.
The TODAY study represents extensive experience managing type 2 diabetes in youth and found that the three treatment approaches were generally safe and well tolerated. Adding rosiglitazone to metformin may reduce GI side effects and hepatotoxicity.</description><identifier>ISSN: 0149-5992</identifier><identifier>EISSN: 1935-5548</identifier><identifier>DOI: 10.2337/dc12-2390</identifier><identifier>PMID: 23704676</identifier><identifier>CODEN: DICAD2</identifier><language>eng</language><publisher>Alexandria, VA: American Diabetes Association</publisher><subject>Adolescent ; Biological and medical sciences ; Blood Glucose - drug effects ; Care and treatment ; Child ; Children & youth ; Clinical trials ; Committees ; Diabetes ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - metabolism ; Diabetes therapy ; Diabetes. Impaired glucose tolerance ; Disease ; Drug Combinations ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Female ; Glycated Hemoglobin A - metabolism ; Heart attacks ; Heart failure ; Hemoglobin ; Humans ; Hypoglycemia ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Insulin ; Male ; Medical sciences ; Metabolic diseases ; Metformin - adverse effects ; Metformin - therapeutic use ; Miscellaneous ; Mortality ; Original Research ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Teenagers ; Thiazoles - adverse effects ; Thiazoles - therapeutic use ; Type 2 diabetes ; Youth</subject><ispartof>Diabetes care, 2013-06, Vol.36 (6), p.1765-1771</ispartof><rights>2014 INIST-CNRS</rights><rights>COPYRIGHT 2013 American Diabetes Association</rights><rights>Copyright American Diabetes Association Jun 2013</rights><rights>2013 by the American Diabetes Association. 2013</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27401556$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23704676$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>TODAY Study Group</creatorcontrib><title>Safety and Tolerability of the Treatment of Youth-Onset Type 2 Diabetes: The TODAY experience</title><title>Diabetes care</title><addtitle>Diabetes Care</addtitle><description>Data related to the safety and tolerability of treatments for pediatric type 2 diabetes are limited. The TODAY clinical trial assessed severe adverse events (SAEs) and targeted nonsevere adverse events (AEs) before and after treatment failure, which was the primary outcome (PO).
Obese 10- to 17-year-olds (N = 699) with type 2 diabetes for <2 years and hemoglobin A1c (A1C) ≤ 8% on metformin monotherapy were randomized to one of three treatments: metformin, metformin plus rosiglitazone (M + R), or metformin plus lifestyle program (M + L). Participants were followed for 2-6.5 years.
Gastrointestinal (GI) disturbance was the most common AE (41%) and was lower in the M + R group (P = 0.018). Other common AEs included anemia (20% before PO, 14% after PO), abnormal liver transaminases (16, 15%), excessive weight gain (7, 9%), and psychological events (10, 18%); the AEs were similar across treatments. Permanent medication reductions/discontinuations occurred most often because of abnormal liver transaminases and were lowest in the M + R group (P = 0.005). Treatment-emergent SAEs were uncommon and similar across treatments. Most (98%) were unrelated or unlikely related to the study intervention. There were no deaths and only 18 targeted SAEs (diabetic ketoacidosis, n = 12; severe hypoglycemia, n = 5; lactic acidosis, n = 1). There were 62 pregnancies occurring in 45 participants, and 6 infants had congenital anomalies.
The TODAY study represents extensive experience managing type 2 diabetes in youth and found that the three treatment approaches were generally safe and well tolerated. Adding rosiglitazone to metformin may reduce GI side effects and hepatotoxicity.</description><subject>Adolescent</subject><subject>Biological and medical sciences</subject><subject>Blood Glucose - drug effects</subject><subject>Care and treatment</subject><subject>Child</subject><subject>Children & youth</subject><subject>Clinical trials</subject><subject>Committees</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - metabolism</subject><subject>Diabetes therapy</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Disease</subject><subject>Drug Combinations</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinopathies</subject><subject>Etiopathogenesis. Screening. Investigations. Target tissue resistance</subject><subject>Female</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Heart attacks</subject><subject>Heart failure</subject><subject>Hemoglobin</subject><subject>Humans</subject><subject>Hypoglycemia</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Metabolic diseases</subject><subject>Metformin - adverse effects</subject><subject>Metformin - therapeutic use</subject><subject>Miscellaneous</subject><subject>Mortality</subject><subject>Original Research</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Teenagers</subject><subject>Thiazoles - adverse effects</subject><subject>Thiazoles - therapeutic use</subject><subject>Type 2 diabetes</subject><subject>Youth</subject><issn>0149-5992</issn><issn>1935-5548</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNptkctu1DAUhi0EotPCghdAkRDLFN-dsEAateUiVZoFYdEFsk7skxlXiTM4GcS8PR4YLpXGXlj6_Z3_3Ah5weglF8K88Y7xkouaPiILVgtVKiWrx2RBmaxLVdf8jJxP0z2lVMqqekrOuDBUaqMX5Otn6HDeFxB90Yw9JmhDH7IwdsW8waJJCPOAcT4Id-Nu3pSrOOFcNPstFry4DtDijNPbojnQq-vlXYE_tpgCRofPyJMO-gmfH98L8uX9TXP1sbxdffh0tbwt15LXc4laGeS-1r6tBevAaOYVhQ4ECuUMd1Ab7SqtsTUOQHnfGckdrVzrPUgpLsi7377bXTugd7neBL3dpjBA2tsRgn34E8PGrsfvVmjNKs6zwaujQRq_7XCa7f24SzHXbJnQqlKs-pXmSK2hRxtiN2YzN4TJ2aU4HJYnnqnyBLXGmIfbjxG7kOUH_OUJPl-PQ3AnA17-3-3fNv9sNQOvjwBMDvouQXRh-scZSZlSWvwEO4mucw</recordid><startdate>20130601</startdate><enddate>20130601</enddate><creator>TODAY Study Group</creator><general>American Diabetes Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>3V.</scope><scope>7RV</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0K</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M2P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope><scope>5PM</scope></search><sort><creationdate>20130601</creationdate><title>Safety and Tolerability of the Treatment of Youth-Onset Type 2 Diabetes: The TODAY experience</title></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-g429t-e657e2d96db931fa761d50afa3e35c72ca976c866eb7caa5ddf742c08cbdda443</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adolescent</topic><topic>Biological and medical sciences</topic><topic>Blood Glucose - drug effects</topic><topic>Care and treatment</topic><topic>Child</topic><topic>Children & youth</topic><topic>Clinical trials</topic><topic>Committees</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - metabolism</topic><topic>Diabetes therapy</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Disease</topic><topic>Drug Combinations</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinopathies</topic><topic>Etiopathogenesis. Screening. Investigations. Target tissue resistance</topic><topic>Female</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Heart attacks</topic><topic>Heart failure</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hypoglycemia</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Insulin</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Metabolic diseases</topic><topic>Metformin - adverse effects</topic><topic>Metformin - therapeutic use</topic><topic>Miscellaneous</topic><topic>Mortality</topic><topic>Original Research</topic><topic>Public health. Hygiene</topic><topic>Public health. Hygiene-occupational medicine</topic><topic>Teenagers</topic><topic>Thiazoles - adverse effects</topic><topic>Thiazoles - therapeutic use</topic><topic>Type 2 diabetes</topic><topic>Youth</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>TODAY Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Agricultural Science Database</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</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>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Diabetes care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><aucorp>TODAY Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and Tolerability of the Treatment of Youth-Onset Type 2 Diabetes: The TODAY experience</atitle><jtitle>Diabetes care</jtitle><addtitle>Diabetes Care</addtitle><date>2013-06-01</date><risdate>2013</risdate><volume>36</volume><issue>6</issue><spage>1765</spage><epage>1771</epage><pages>1765-1771</pages><issn>0149-5992</issn><eissn>1935-5548</eissn><coden>DICAD2</coden><abstract>Data related to the safety and tolerability of treatments for pediatric type 2 diabetes are limited. The TODAY clinical trial assessed severe adverse events (SAEs) and targeted nonsevere adverse events (AEs) before and after treatment failure, which was the primary outcome (PO).
Obese 10- to 17-year-olds (N = 699) with type 2 diabetes for <2 years and hemoglobin A1c (A1C) ≤ 8% on metformin monotherapy were randomized to one of three treatments: metformin, metformin plus rosiglitazone (M + R), or metformin plus lifestyle program (M + L). Participants were followed for 2-6.5 years.
Gastrointestinal (GI) disturbance was the most common AE (41%) and was lower in the M + R group (P = 0.018). Other common AEs included anemia (20% before PO, 14% after PO), abnormal liver transaminases (16, 15%), excessive weight gain (7, 9%), and psychological events (10, 18%); the AEs were similar across treatments. Permanent medication reductions/discontinuations occurred most often because of abnormal liver transaminases and were lowest in the M + R group (P = 0.005). Treatment-emergent SAEs were uncommon and similar across treatments. Most (98%) were unrelated or unlikely related to the study intervention. There were no deaths and only 18 targeted SAEs (diabetic ketoacidosis, n = 12; severe hypoglycemia, n = 5; lactic acidosis, n = 1). There were 62 pregnancies occurring in 45 participants, and 6 infants had congenital anomalies.
The TODAY study represents extensive experience managing type 2 diabetes in youth and found that the three treatment approaches were generally safe and well tolerated. Adding rosiglitazone to metformin may reduce GI side effects and hepatotoxicity.</abstract><cop>Alexandria, VA</cop><pub>American Diabetes Association</pub><pmid>23704676</pmid><doi>10.2337/dc12-2390</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0149-5992 |
| ispartof | Diabetes care, 2013-06, Vol.36 (6), p.1765-1771 |
| issn | 0149-5992 1935-5548 |
| language | eng |
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| source | Journals@Ovid Ovid Autoload; MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Adolescent Biological and medical sciences Blood Glucose - drug effects Care and treatment Child Children & youth Clinical trials Committees Diabetes Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - metabolism Diabetes therapy Diabetes. Impaired glucose tolerance Disease Drug Combinations Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance Female Glycated Hemoglobin A - metabolism Heart attacks Heart failure Hemoglobin Humans Hypoglycemia Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Insulin Male Medical sciences Metabolic diseases Metformin - adverse effects Metformin - therapeutic use Miscellaneous Mortality Original Research Public health. Hygiene Public health. Hygiene-occupational medicine Teenagers Thiazoles - adverse effects Thiazoles - therapeutic use Type 2 diabetes Youth |
| title | Safety and Tolerability of the Treatment of Youth-Onset Type 2 Diabetes: The TODAY experience |
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