Loading…

Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes

Objective We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy. Study Design We conducted a randomized, controlled noninferiority trial of...

Full description

Saved in:

Bibliographic Details
Published in:	American journal of obstetrics and gynecology 2015-09, Vol.213 (3), p.426.e1-426.e7
Main Authors:	Herrera, Kimberly M., MD, Rosenn, Barak M., MD, Foroutan, Janelle, MD, Bimson, Brianne E., MD, Al Ibraheemi, Zainab, MD, Moshier, Erin L., MS, Brustman, Lois E., MD
Format:	Article
Language:	English
Subjects:	Adolescent Adult Diabetes Mellitus, Type 2 - drug therapy Diabetes, Gestational - drug therapy Drug Administration Schedule Female gestational diabetes Humans Hypoglycemic Agents - therapeutic use Insulin Detemir insulin neutral protamine Hagedorn Insulin, Isophane - therapeutic use Insulin, Long-Acting - therapeutic use Intention to Treat Analysis Obstetrics and Gynecology Pregnancy Pregnancy in Diabetics - drug therapy Treatment Outcome type 2 diabetes Young Adult
Citations:	Items that this one cites Items that cite this one
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

cited_by	cdi_FETCH-LOGICAL-c481t-888b990e389e5c006c9a9f22d1edf74cc9b1730bc2337bf13d0e72d36cd86b173
cites	cdi_FETCH-LOGICAL-c481t-888b990e389e5c006c9a9f22d1edf74cc9b1730bc2337bf13d0e72d36cd86b173
container_end_page	426.e7
container_issue	3
container_start_page	426.e1
container_title	American journal of obstetrics and gynecology
container_volume	213
creator	Herrera, Kimberly M., MD Rosenn, Barak M., MD Foroutan, Janelle, MD Bimson, Brianne E., MD Al Ibraheemi, Zainab, MD Moshier, Erin L., MS Brustman, Lois E., MD
description	Objective We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy. Study Design We conducted a randomized, controlled noninferiority trial of women with GDM and T2DM who entered our Diabetes in Pregnancy Program from March 2013 through October 2014. Exclusion criteria were type 1 diabetes, age
doi_str_mv	10.1016/j.ajog.2015.06.010
format	article
fullrecord	<record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1708899151</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>1_s2_0_S0002937815005931</els_id><sourcerecordid>1708899151</sourcerecordid><originalsourceid>FETCH-LOGICAL-c481t-888b990e389e5c006c9a9f22d1edf74cc9b1730bc2337bf13d0e72d36cd86b173</originalsourceid><addsrcrecordid>eNp9kc1u1TAQhS0EoreFF2CBvGSTMHYax5YQEqqAIlWA-Flbjj1pnSbxxXZalaevo1tYsGDlsX3OkeY7hLxgUDNg4vVYmzFc1hxYW4OogcEjsmOgukpIIR-THQDwSjWdPCLHKY3blSv-lBxxAR0IpXbk-ptZXJj9b3TUhiXHME1lzNGbiYaB-iWtk1-ow4yzj_QGY1oT_fz1nA4h0nyFRYsmz7jkTb-PeLmYMt-G8kRvfb6izpu-2NMz8mQwU8LnD-cJ-fnh_Y-z8-riy8dPZ-8uKnsqWa6klL1SgI1U2FoAYZVRA-eOoRu6U2tVz7oGesubpusH1jjAjrtGWCfF9nVCXh1y9zH8WjFlPftkcZrMgmFNmnUgpVKsZUXKD1IbQ0oRB72PfjbxTjPQG2Q96g2y3iBrELpALqaXD_lrP6P7a_lDtQjeHARYtrzxGHWyHheLzke0Wbvg_5__9h-7LRV4a6ZrvMM0hjUuhZ9mOnEN-vvW69YyawFa1bDmHhZCo7U</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1708899151</pqid></control><display><type>article</type><title>Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes</title><source>ScienceDirect Journals</source><creator>Herrera, Kimberly M., MD ; Rosenn, Barak M., MD ; Foroutan, Janelle, MD ; Bimson, Brianne E., MD ; Al Ibraheemi, Zainab, MD ; Moshier, Erin L., MS ; Brustman, Lois E., MD</creator><creatorcontrib>Herrera, Kimberly M., MD ; Rosenn, Barak M., MD ; Foroutan, Janelle, MD ; Bimson, Brianne E., MD ; Al Ibraheemi, Zainab, MD ; Moshier, Erin L., MS ; Brustman, Lois E., MD</creatorcontrib><description>Objective We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy. Study Design We conducted a randomized, controlled noninferiority trial of women with GDM and T2DM who entered our Diabetes in Pregnancy Program from March 2013 through October 2014. Exclusion criteria were type 1 diabetes, age <18 years, and insulin allergy. Women who failed to achieve good glycemic control (GC) (mean blood glucose [BG] <100 mg/dL) on diet and/or hypoglycemic agents were randomized to receive either IDet or NPH, with short-acting insulin aspart added as needed. Patients were instructed to test BG 4 times a day (fasting and 2-hour postprandial). Targets of GC were fasting BG <90 mg/dL and postprandial BG <120 mg/dL, and insulin was adjusted as needed to achieve the targets. The primary outcome was overall mean BG during insulin treatment; secondary outcomes included overall mean postprandial and fasting BG, median number of weeks to achieve GC, percent of patients with overall GC, maternal weight gain, perinatal/neonatal outcomes, and number of hypoglycemic events. Power analysis (90% power) determined that 88 patients would need to be randomized, assuming a maximal acceptable difference in overall mean BG of 7 mg/dL (SD ± 10 mg/dL). A per protocol analysis was performed. Results In all, 105 women were randomized. Eighteen women were excluded leaving 87 participants for analysis (45 NPH, 42 IDet). Maternal characteristics were similar in both groups. The difference in the mean BG of the groups was 2.1 mg/dL with a 1-sided upper 95% confidence limit of 5.5 mg/dL (less than the maximal acceptable difference of 7 mg/dL; P = .2937). There was no significant difference in the primary outcome when an intent-to-treat analysis was performed or when the T2DM patients were excluded. The time to achieve GC was similar in both groups. There were no differences in perinatal outcomes and maternal weight gain among the groups. There were more hypoglycemic events per patient in the NPH group. Conclusion IDet is noninferior to insulin NPH for the treatment of GDM and T2DM in pregnancy.</description><identifier>ISSN: 0002-9378</identifier><identifier>EISSN: 1097-6868</identifier><identifier>DOI: 10.1016/j.ajog.2015.06.010</identifier><identifier>PMID: 26070699</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes, Gestational - drug therapy ; Drug Administration Schedule ; Female ; gestational diabetes ; Humans ; Hypoglycemic Agents - therapeutic use ; Insulin Detemir ; insulin neutral protamine Hagedorn ; Insulin, Isophane - therapeutic use ; Insulin, Long-Acting - therapeutic use ; Intention to Treat Analysis ; Obstetrics and Gynecology ; Pregnancy ; Pregnancy in Diabetics - drug therapy ; Treatment Outcome ; type 2 diabetes ; Young Adult</subject><ispartof>American journal of obstetrics and gynecology, 2015-09, Vol.213 (3), p.426.e1-426.e7</ispartof><rights>Elsevier Inc.</rights><rights>2015 Elsevier Inc.</rights><rights>Copyright © 2015 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c481t-888b990e389e5c006c9a9f22d1edf74cc9b1730bc2337bf13d0e72d36cd86b173</citedby><cites>FETCH-LOGICAL-c481t-888b990e389e5c006c9a9f22d1edf74cc9b1730bc2337bf13d0e72d36cd86b173</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26070699$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Herrera, Kimberly M., MD</creatorcontrib><creatorcontrib>Rosenn, Barak M., MD</creatorcontrib><creatorcontrib>Foroutan, Janelle, MD</creatorcontrib><creatorcontrib>Bimson, Brianne E., MD</creatorcontrib><creatorcontrib>Al Ibraheemi, Zainab, MD</creatorcontrib><creatorcontrib>Moshier, Erin L., MS</creatorcontrib><creatorcontrib>Brustman, Lois E., MD</creatorcontrib><title>Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes</title><title>American journal of obstetrics and gynecology</title><addtitle>Am J Obstet Gynecol</addtitle><description>Objective We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy. Study Design We conducted a randomized, controlled noninferiority trial of women with GDM and T2DM who entered our Diabetes in Pregnancy Program from March 2013 through October 2014. Exclusion criteria were type 1 diabetes, age <18 years, and insulin allergy. Women who failed to achieve good glycemic control (GC) (mean blood glucose [BG] <100 mg/dL) on diet and/or hypoglycemic agents were randomized to receive either IDet or NPH, with short-acting insulin aspart added as needed. Patients were instructed to test BG 4 times a day (fasting and 2-hour postprandial). Targets of GC were fasting BG <90 mg/dL and postprandial BG <120 mg/dL, and insulin was adjusted as needed to achieve the targets. The primary outcome was overall mean BG during insulin treatment; secondary outcomes included overall mean postprandial and fasting BG, median number of weeks to achieve GC, percent of patients with overall GC, maternal weight gain, perinatal/neonatal outcomes, and number of hypoglycemic events. Power analysis (90% power) determined that 88 patients would need to be randomized, assuming a maximal acceptable difference in overall mean BG of 7 mg/dL (SD ± 10 mg/dL). A per protocol analysis was performed. Results In all, 105 women were randomized. Eighteen women were excluded leaving 87 participants for analysis (45 NPH, 42 IDet). Maternal characteristics were similar in both groups. The difference in the mean BG of the groups was 2.1 mg/dL with a 1-sided upper 95% confidence limit of 5.5 mg/dL (less than the maximal acceptable difference of 7 mg/dL; P = .2937). There was no significant difference in the primary outcome when an intent-to-treat analysis was performed or when the T2DM patients were excluded. The time to achieve GC was similar in both groups. There were no differences in perinatal outcomes and maternal weight gain among the groups. There were more hypoglycemic events per patient in the NPH group. Conclusion IDet is noninferior to insulin NPH for the treatment of GDM and T2DM in pregnancy.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes, Gestational - drug therapy</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>gestational diabetes</subject><subject>Humans</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin Detemir</subject><subject>insulin neutral protamine Hagedorn</subject><subject>Insulin, Isophane - therapeutic use</subject><subject>Insulin, Long-Acting - therapeutic use</subject><subject>Intention to Treat Analysis</subject><subject>Obstetrics and Gynecology</subject><subject>Pregnancy</subject><subject>Pregnancy in Diabetics - drug therapy</subject><subject>Treatment Outcome</subject><subject>type 2 diabetes</subject><subject>Young Adult</subject><issn>0002-9378</issn><issn>1097-6868</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><recordid>eNp9kc1u1TAQhS0EoreFF2CBvGSTMHYax5YQEqqAIlWA-Flbjj1pnSbxxXZalaevo1tYsGDlsX3OkeY7hLxgUDNg4vVYmzFc1hxYW4OogcEjsmOgukpIIR-THQDwSjWdPCLHKY3blSv-lBxxAR0IpXbk-ptZXJj9b3TUhiXHME1lzNGbiYaB-iWtk1-ow4yzj_QGY1oT_fz1nA4h0nyFRYsmz7jkTb-PeLmYMt-G8kRvfb6izpu-2NMz8mQwU8LnD-cJ-fnh_Y-z8-riy8dPZ-8uKnsqWa6klL1SgI1U2FoAYZVRA-eOoRu6U2tVz7oGesubpusH1jjAjrtGWCfF9nVCXh1y9zH8WjFlPftkcZrMgmFNmnUgpVKsZUXKD1IbQ0oRB72PfjbxTjPQG2Q96g2y3iBrELpALqaXD_lrP6P7a_lDtQjeHARYtrzxGHWyHheLzke0Wbvg_5__9h-7LRV4a6ZrvMM0hjUuhZ9mOnEN-vvW69YyawFa1bDmHhZCo7U</recordid><startdate>20150901</startdate><enddate>20150901</enddate><creator>Herrera, Kimberly M., MD</creator><creator>Rosenn, Barak M., MD</creator><creator>Foroutan, Janelle, MD</creator><creator>Bimson, Brianne E., MD</creator><creator>Al Ibraheemi, Zainab, MD</creator><creator>Moshier, Erin L., MS</creator><creator>Brustman, Lois E., MD</creator><general>Elsevier Inc</general><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>7X8</scope></search><sort><creationdate>20150901</creationdate><title>Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes</title><author>Herrera, Kimberly M., MD ; Rosenn, Barak M., MD ; Foroutan, Janelle, MD ; Bimson, Brianne E., MD ; Al Ibraheemi, Zainab, MD ; Moshier, Erin L., MS ; Brustman, Lois E., MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c481t-888b990e389e5c006c9a9f22d1edf74cc9b1730bc2337bf13d0e72d36cd86b173</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes, Gestational - drug therapy</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>gestational diabetes</topic><topic>Humans</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Insulin Detemir</topic><topic>insulin neutral protamine Hagedorn</topic><topic>Insulin, Isophane - therapeutic use</topic><topic>Insulin, Long-Acting - therapeutic use</topic><topic>Intention to Treat Analysis</topic><topic>Obstetrics and Gynecology</topic><topic>Pregnancy</topic><topic>Pregnancy in Diabetics - drug therapy</topic><topic>Treatment Outcome</topic><topic>type 2 diabetes</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Herrera, Kimberly M., MD</creatorcontrib><creatorcontrib>Rosenn, Barak M., MD</creatorcontrib><creatorcontrib>Foroutan, Janelle, MD</creatorcontrib><creatorcontrib>Bimson, Brianne E., MD</creatorcontrib><creatorcontrib>Al Ibraheemi, Zainab, MD</creatorcontrib><creatorcontrib>Moshier, Erin L., MS</creatorcontrib><creatorcontrib>Brustman, Lois E., MD</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>American journal of obstetrics and gynecology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Herrera, Kimberly M., MD</au><au>Rosenn, Barak M., MD</au><au>Foroutan, Janelle, MD</au><au>Bimson, Brianne E., MD</au><au>Al Ibraheemi, Zainab, MD</au><au>Moshier, Erin L., MS</au><au>Brustman, Lois E., MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes</atitle><jtitle>American journal of obstetrics and gynecology</jtitle><addtitle>Am J Obstet Gynecol</addtitle><date>2015-09-01</date><risdate>2015</risdate><volume>213</volume><issue>3</issue><spage>426.e1</spage><epage>426.e7</epage><pages>426.e1-426.e7</pages><issn>0002-9378</issn><eissn>1097-6868</eissn><abstract>Objective We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy. Study Design We conducted a randomized, controlled noninferiority trial of women with GDM and T2DM who entered our Diabetes in Pregnancy Program from March 2013 through October 2014. Exclusion criteria were type 1 diabetes, age <18 years, and insulin allergy. Women who failed to achieve good glycemic control (GC) (mean blood glucose [BG] <100 mg/dL) on diet and/or hypoglycemic agents were randomized to receive either IDet or NPH, with short-acting insulin aspart added as needed. Patients were instructed to test BG 4 times a day (fasting and 2-hour postprandial). Targets of GC were fasting BG <90 mg/dL and postprandial BG <120 mg/dL, and insulin was adjusted as needed to achieve the targets. The primary outcome was overall mean BG during insulin treatment; secondary outcomes included overall mean postprandial and fasting BG, median number of weeks to achieve GC, percent of patients with overall GC, maternal weight gain, perinatal/neonatal outcomes, and number of hypoglycemic events. Power analysis (90% power) determined that 88 patients would need to be randomized, assuming a maximal acceptable difference in overall mean BG of 7 mg/dL (SD ± 10 mg/dL). A per protocol analysis was performed. Results In all, 105 women were randomized. Eighteen women were excluded leaving 87 participants for analysis (45 NPH, 42 IDet). Maternal characteristics were similar in both groups. The difference in the mean BG of the groups was 2.1 mg/dL with a 1-sided upper 95% confidence limit of 5.5 mg/dL (less than the maximal acceptable difference of 7 mg/dL; P = .2937). There was no significant difference in the primary outcome when an intent-to-treat analysis was performed or when the T2DM patients were excluded. The time to achieve GC was similar in both groups. There were no differences in perinatal outcomes and maternal weight gain among the groups. There were more hypoglycemic events per patient in the NPH group. Conclusion IDet is noninferior to insulin NPH for the treatment of GDM and T2DM in pregnancy.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26070699</pmid><doi>10.1016/j.ajog.2015.06.010</doi></addata></record>
fulltext	fulltext
identifier	ISSN: 0002-9378
ispartof	American journal of obstetrics and gynecology, 2015-09, Vol.213 (3), p.426.e1-426.e7
issn	0002-9378 1097-6868
language	eng
recordid	cdi_proquest_miscellaneous_1708899151
source	ScienceDirect Journals
subjects	Adolescent Adult Diabetes Mellitus, Type 2 - drug therapy Diabetes, Gestational - drug therapy Drug Administration Schedule Female gestational diabetes Humans Hypoglycemic Agents - therapeutic use Insulin Detemir insulin neutral protamine Hagedorn Insulin, Isophane - therapeutic use Insulin, Long-Acting - therapeutic use Intention to Treat Analysis Obstetrics and Gynecology Pregnancy Pregnancy in Diabetics - drug therapy Treatment Outcome type 2 diabetes Young Adult
title	Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes
url	http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-01T17%3A15%3A42IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Randomized%20controlled%20trial%20of%20insulin%20detemir%20versus%20NPH%20for%20the%20treatment%20of%20pregnant%20women%20with%20diabetes&rft.jtitle=American%20journal%20of%20obstetrics%20and%20gynecology&rft.au=Herrera,%20Kimberly%20M.,%20MD&rft.date=2015-09-01&rft.volume=213&rft.issue=3&rft.spage=426.e1&rft.epage=426.e7&rft.pages=426.e1-426.e7&rft.issn=0002-9378&rft.eissn=1097-6868&rft_id=info:doi/10.1016/j.ajog.2015.06.010&rft_dat=%3Cproquest_cross%3E1708899151%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c481t-888b990e389e5c006c9a9f22d1edf74cc9b1730bc2337bf13d0e72d36cd86b173%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=1708899151&rft_id=info:pmid/26070699&rfr_iscdi=true