Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial
IMPORTANCE: Randomized trials have not focused on neonatal complications of glyburide for women with gestational diabetes. OBJECTIVE: To compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes. DESIGN, SETTINGS, AND PARTI...
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| Veröffentlicht in: | JAMA : the journal of the American Medical Association 2018-05, Vol.319 (17), p.1773-1780 |
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| creator | Sénat, Marie-Victoire Affres, Helene Letourneau, Alexandra Coustols-Valat, Magali Cazaubiel, Marie Legardeur, Helene Jacquier, Julie Fort Bourcigaux, Nathalie Simon, Emmanuel Rod, Anne Héron, Isabelle Castera, Virginie Sentilhes, Loic Bretelle, Florence Rolland, Catherine Morin, Mathieu Deruelle, Philippe De Carne, Celine Maillot, François Beucher, Gael Verspyck, Eric Desbriere, Raoul Laboureau, Sandrine Mitanchez, Delphine Bouyer, Jean |
| description | IMPORTANCE: Randomized trials have not focused on neonatal complications of glyburide for women with gestational diabetes. OBJECTIVE: To compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes. DESIGN, SETTINGS, AND PARTICIPANTS: The Insulin Daonil trial (INDAO), a multicenter noninferiority randomized trial conducted between May 2012 and November 2016 (end of participant follow-up) in 13 tertiary care university hospitals in France including 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation. INTERVENTIONS: Women who required pharmacologic treatment after 10 days of dietary intervention were randomly assigned to receive glyburide (n=460) or insulin (n=454). The starting dosage for glyburide was 2.5 mg orally once per day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 5 mg every 4 days in 2 morning and evening doses, up to a maximum of 20 mg/d. The starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times per day as necessary and increased according to self-measured blood glucose concentrations. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite criterion including macrosomia, neonatal hypoglycemia, and hyperbilirubinemia. The noninferiority margin was set at 7% based on a 1-sided 97.5% confidence interval. RESULTS: Among the 914 patients who were randomized (mean age, 32.8 [SD, 5.2] years), 98% completed the trial. In a per-protocol analysis, 367 and 442 women and their neonates were analyzed in the glyburide and insulin groups, respectively. The frequency of the primary outcome was 27.6% in the glyburide group and 23.4% in the insulin group, a difference of 4.2% (1-sided 97.5% CI, −∞ to 10.5%; P=.19). CONCLUSION AND RELEVANCE: This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications. These findings do not justify the use of glyburide as a first-line treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01731431 |
| doi_str_mv | 10.1001/jama.2018.4072 |
| format | Article |
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OBJECTIVE: To compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes. DESIGN, SETTINGS, AND PARTICIPANTS: The Insulin Daonil trial (INDAO), a multicenter noninferiority randomized trial conducted between May 2012 and November 2016 (end of participant follow-up) in 13 tertiary care university hospitals in France including 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation. INTERVENTIONS: Women who required pharmacologic treatment after 10 days of dietary intervention were randomly assigned to receive glyburide (n=460) or insulin (n=454). The starting dosage for glyburide was 2.5 mg orally once per day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 5 mg every 4 days in 2 morning and evening doses, up to a maximum of 20 mg/d. The starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times per day as necessary and increased according to self-measured blood glucose concentrations. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite criterion including macrosomia, neonatal hypoglycemia, and hyperbilirubinemia. The noninferiority margin was set at 7% based on a 1-sided 97.5% confidence interval. RESULTS: Among the 914 patients who were randomized (mean age, 32.8 [SD, 5.2] years), 98% completed the trial. In a per-protocol analysis, 367 and 442 women and their neonates were analyzed in the glyburide and insulin groups, respectively. The frequency of the primary outcome was 27.6% in the glyburide group and 23.4% in the insulin group, a difference of 4.2% (1-sided 97.5% CI, −∞ to 10.5%; P=.19). CONCLUSION AND RELEVANCE: This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications. These findings do not justify the use of glyburide as a first-line treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01731431</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.2018.4072</identifier><identifier>PMID: 29715355</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Administration, Oral ; Adult ; Blood glucose ; Blood Glucose - analysis ; Clinical trials ; Complications ; Confidence intervals ; Diabetes ; Diabetes mellitus ; Diabetes, Gestational - blood ; Diabetes, Gestational - drug therapy ; Diet ; Disease prevention ; Dosage ; Female ; Fetal Macrosomia - etiology ; Fetal Macrosomia - prevention & control ; Gestation ; Gestational diabetes ; Glyburide - adverse effects ; Glyburide - therapeutic use ; Human health and pathology ; Humans ; Hyperbilirubinemia ; Hyperbilirubinemia - etiology ; Hyperbilirubinemia - prevention & control ; Hypoglycemia ; Hypoglycemia - chemically induced ; Hypoglycemia - etiology ; Hypoglycemia - prevention & control ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Infant, Newborn ; Infant, Newborn, Diseases - epidemiology ; Infectious diseases ; Injections, Subcutaneous ; Insulin ; Insulin - adverse effects ; Insulin - therapeutic use ; Life Sciences ; Neonates ; Original Investigation ; Pharmacology ; Pregnancy ; Pregnancy Outcome ; Womens health</subject><ispartof>JAMA : the journal of the American Medical Association, 2018-05, Vol.319 (17), p.1773-1780</ispartof><rights>Copyright American Medical Association May 1, 2018</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><rights>Copyright 2018 American Medical Association. All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0003-4861-0783 ; 0000-0003-4273-6553</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.2018.4072$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2018.4072$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,776,780,881,3327,27901,27902,76231,76234</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29715355$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-01791582$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Sénat, Marie-Victoire</creatorcontrib><creatorcontrib>Affres, Helene</creatorcontrib><creatorcontrib>Letourneau, Alexandra</creatorcontrib><creatorcontrib>Coustols-Valat, Magali</creatorcontrib><creatorcontrib>Cazaubiel, Marie</creatorcontrib><creatorcontrib>Legardeur, Helene</creatorcontrib><creatorcontrib>Jacquier, Julie Fort</creatorcontrib><creatorcontrib>Bourcigaux, Nathalie</creatorcontrib><creatorcontrib>Simon, Emmanuel</creatorcontrib><creatorcontrib>Rod, Anne</creatorcontrib><creatorcontrib>Héron, Isabelle</creatorcontrib><creatorcontrib>Castera, Virginie</creatorcontrib><creatorcontrib>Sentilhes, Loic</creatorcontrib><creatorcontrib>Bretelle, Florence</creatorcontrib><creatorcontrib>Rolland, Catherine</creatorcontrib><creatorcontrib>Morin, Mathieu</creatorcontrib><creatorcontrib>Deruelle, Philippe</creatorcontrib><creatorcontrib>De Carne, Celine</creatorcontrib><creatorcontrib>Maillot, François</creatorcontrib><creatorcontrib>Beucher, Gael</creatorcontrib><creatorcontrib>Verspyck, Eric</creatorcontrib><creatorcontrib>Desbriere, Raoul</creatorcontrib><creatorcontrib>Laboureau, Sandrine</creatorcontrib><creatorcontrib>Mitanchez, Delphine</creatorcontrib><creatorcontrib>Bouyer, Jean</creatorcontrib><creatorcontrib>Groupe de Recherche en Obstétrique et Gynécologie (GROG)</creatorcontrib><creatorcontrib>for the Groupe de Recherche en Obstétrique et Gynécologie (GROG)</creatorcontrib><title>Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>IMPORTANCE: Randomized trials have not focused on neonatal complications of glyburide for women with gestational diabetes. OBJECTIVE: To compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes. DESIGN, SETTINGS, AND PARTICIPANTS: The Insulin Daonil trial (INDAO), a multicenter noninferiority randomized trial conducted between May 2012 and November 2016 (end of participant follow-up) in 13 tertiary care university hospitals in France including 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation. INTERVENTIONS: Women who required pharmacologic treatment after 10 days of dietary intervention were randomly assigned to receive glyburide (n=460) or insulin (n=454). The starting dosage for glyburide was 2.5 mg orally once per day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 5 mg every 4 days in 2 morning and evening doses, up to a maximum of 20 mg/d. The starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times per day as necessary and increased according to self-measured blood glucose concentrations. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite criterion including macrosomia, neonatal hypoglycemia, and hyperbilirubinemia. The noninferiority margin was set at 7% based on a 1-sided 97.5% confidence interval. RESULTS: Among the 914 patients who were randomized (mean age, 32.8 [SD, 5.2] years), 98% completed the trial. In a per-protocol analysis, 367 and 442 women and their neonates were analyzed in the glyburide and insulin groups, respectively. The frequency of the primary outcome was 27.6% in the glyburide group and 23.4% in the insulin group, a difference of 4.2% (1-sided 97.5% CI, −∞ to 10.5%; P=.19). CONCLUSION AND RELEVANCE: This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications. These findings do not justify the use of glyburide as a first-line treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01731431</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Blood glucose</subject><subject>Blood Glucose - analysis</subject><subject>Clinical trials</subject><subject>Complications</subject><subject>Confidence intervals</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes, Gestational - blood</subject><subject>Diabetes, Gestational - drug therapy</subject><subject>Diet</subject><subject>Disease prevention</subject><subject>Dosage</subject><subject>Female</subject><subject>Fetal Macrosomia - etiology</subject><subject>Fetal Macrosomia - prevention & control</subject><subject>Gestation</subject><subject>Gestational diabetes</subject><subject>Glyburide - adverse effects</subject><subject>Glyburide - therapeutic use</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Hyperbilirubinemia</subject><subject>Hyperbilirubinemia - etiology</subject><subject>Hyperbilirubinemia - 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Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sénat, Marie-Victoire</au><au>Affres, Helene</au><au>Letourneau, Alexandra</au><au>Coustols-Valat, Magali</au><au>Cazaubiel, Marie</au><au>Legardeur, Helene</au><au>Jacquier, Julie Fort</au><au>Bourcigaux, Nathalie</au><au>Simon, Emmanuel</au><au>Rod, Anne</au><au>Héron, Isabelle</au><au>Castera, Virginie</au><au>Sentilhes, Loic</au><au>Bretelle, Florence</au><au>Rolland, Catherine</au><au>Morin, Mathieu</au><au>Deruelle, Philippe</au><au>De Carne, Celine</au><au>Maillot, François</au><au>Beucher, Gael</au><au>Verspyck, Eric</au><au>Desbriere, Raoul</au><au>Laboureau, Sandrine</au><au>Mitanchez, Delphine</au><au>Bouyer, Jean</au><aucorp>Groupe de Recherche en Obstétrique et Gynécologie (GROG)</aucorp><aucorp>for the Groupe de Recherche en Obstétrique et Gynécologie (GROG)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2018-05-01</date><risdate>2018</risdate><volume>319</volume><issue>17</issue><spage>1773</spage><epage>1780</epage><pages>1773-1780</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><abstract>IMPORTANCE: Randomized trials have not focused on neonatal complications of glyburide for women with gestational diabetes. OBJECTIVE: To compare oral glyburide vs subcutaneous insulin in prevention of perinatal complications in newborns of women with gestational diabetes. DESIGN, SETTINGS, AND PARTICIPANTS: The Insulin Daonil trial (INDAO), a multicenter noninferiority randomized trial conducted between May 2012 and November 2016 (end of participant follow-up) in 13 tertiary care university hospitals in France including 914 women with singleton pregnancies and gestational diabetes diagnosed between 24 and 34 weeks of gestation. INTERVENTIONS: Women who required pharmacologic treatment after 10 days of dietary intervention were randomly assigned to receive glyburide (n=460) or insulin (n=454). The starting dosage for glyburide was 2.5 mg orally once per day and could be increased if necessary 4 days later by 2.5 mg and thereafter by 5 mg every 4 days in 2 morning and evening doses, up to a maximum of 20 mg/d. The starting dosage for insulin was 4 IU to 20 IU given subcutaneously 1 to 4 times per day as necessary and increased according to self-measured blood glucose concentrations. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite criterion including macrosomia, neonatal hypoglycemia, and hyperbilirubinemia. The noninferiority margin was set at 7% based on a 1-sided 97.5% confidence interval. RESULTS: Among the 914 patients who were randomized (mean age, 32.8 [SD, 5.2] years), 98% completed the trial. In a per-protocol analysis, 367 and 442 women and their neonates were analyzed in the glyburide and insulin groups, respectively. The frequency of the primary outcome was 27.6% in the glyburide group and 23.4% in the insulin group, a difference of 4.2% (1-sided 97.5% CI, −∞ to 10.5%; P=.19). CONCLUSION AND RELEVANCE: This study of women with gestational diabetes failed to show that use of glyburide compared with subcutaneous insulin does not result in a greater frequency of perinatal complications. These findings do not justify the use of glyburide as a first-line treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01731431</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>29715355</pmid><doi>10.1001/jama.2018.4072</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-4861-0783</orcidid><orcidid>https://orcid.org/0000-0003-4273-6553</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0098-7484 |
| ispartof | JAMA : the journal of the American Medical Association, 2018-05, Vol.319 (17), p.1773-1780 |
| issn | 0098-7484 1538-3598 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6583037 |
| source | MEDLINE; American Medical Association Journals |
| subjects | Administration, Oral Adult Blood glucose Blood Glucose - analysis Clinical trials Complications Confidence intervals Diabetes Diabetes mellitus Diabetes, Gestational - blood Diabetes, Gestational - drug therapy Diet Disease prevention Dosage Female Fetal Macrosomia - etiology Fetal Macrosomia - prevention & control Gestation Gestational diabetes Glyburide - adverse effects Glyburide - therapeutic use Human health and pathology Humans Hyperbilirubinemia Hyperbilirubinemia - etiology Hyperbilirubinemia - prevention & control Hypoglycemia Hypoglycemia - chemically induced Hypoglycemia - etiology Hypoglycemia - prevention & control Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Infant, Newborn Infant, Newborn, Diseases - epidemiology Infectious diseases Injections, Subcutaneous Insulin Insulin - adverse effects Insulin - therapeutic use Life Sciences Neonates Original Investigation Pharmacology Pregnancy Pregnancy Outcome Womens health |
| title | Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial |
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