Safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus from Gulf countries during Ramadan holy month: A subgroup analysis of the SoliRam observational study
•This subanalysis of the SoliRam study was conducted in people with type 2 diabetes mellitus receiving iGlarLixi during Ramadan in Gulf countries.•iGlarLixi was associated with low risk of hypoglycemia, including during Ramadan fasting.•Improvements were observed in HbA1c, FPG and body weight from p...
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| container_title | Diabetes research and clinical practice |
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| creator | Hassanein, Mohamed El Naggar, Adel Al Sheikh, Abdulrahman Djaballah, Khier Saeed, Mohamed Melas-Melt, Lydie AlSifri, Saud |
| description | •This subanalysis of the SoliRam study was conducted in people with type 2 diabetes mellitus receiving iGlarLixi during Ramadan in Gulf countries.•iGlarLixi was associated with low risk of hypoglycemia, including during Ramadan fasting.•Improvements were observed in HbA1c, FPG and body weight from pre-Ramadan to post-Ramadan.•The benefits of iGlarLixi were seen both during and post-Ramadan.
To investigate safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus (T2DM) observing fast during Ramadan from Gulf countries.
This planned subgroup analysis of the SoliRam – a multinational, prospective, non-interventional, real-world, observational study – focused on participants from Gulf countries. Primary endpoint was proportion of participants experiencing ≥1 episode of severe and/or symptomatic documented ( |
| doi_str_mv | 10.1016/j.diabres.2024.111567 |
| format | Article |
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To investigate safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus (T2DM) observing fast during Ramadan from Gulf countries.
This planned subgroup analysis of the SoliRam – a multinational, prospective, non-interventional, real-world, observational study – focused on participants from Gulf countries. Primary endpoint was proportion of participants experiencing ≥1 episode of severe and/or symptomatic documented (<70 mg/dL [<3.9 mmol/L]) hypoglycemia.
A total of 241 individuals with T2DM (mean age: 58.1 years; male: 54.4%; mean duration of diabetes: 13.3 years) were included. All 234 eligible participants followed during Ramadan were able to fast for ≥25 days and no participants broke fast due to hypoglycemia. Primary endpoint was reported in one participant (0.5%) during fasting hours during Ramadan. Improvements (mean ± SD change) in HbA1c (–1.0 ± 1.0% [–11 ± 10 mmol/mol]), FPG (–22.5 ± 29.7 mg/dL), and body weight (–1.5 ± 2.0 kg) were observed from pre-Ramadan to post-Ramadan. Three participants (1.2 %) reported an adverse event (AE) of any cause and one (0.4%) reported a gastrointestinal AE.
iGlarLixi is an effective and well-tolerated treatment in people with T2DM from Gulf countries, including during Ramadan fasting, and is associated with low risk of hypoglycemia.</description><identifier>ISSN: 0168-8227</identifier><identifier>EISSN: 1872-8227</identifier><identifier>DOI: 10.1016/j.diabres.2024.111567</identifier><identifier>PMID: 38341039</identifier><language>eng</language><publisher>Ireland: Elsevier B.V</publisher><subject>Adult ; Blood Glucose ; Diabetes Mellitus, Type 2 - chemically induced ; Diabetes Mellitus, Type 2 - drug therapy ; Fasting - adverse effects ; Gulf countries ; Humans ; Hypoglycemia ; Hypoglycemia - chemically induced ; Hypoglycemia - epidemiology ; Hypoglycemic Agents - adverse effects ; iGlarLixi ; Islam ; Male ; Middle Aged ; Prospective Studies ; Ramadan fasting ; Type 2 diabetes mellitus</subject><ispartof>Diabetes research and clinical practice, 2024-03, Vol.209, p.111567-111567, Article 111567</ispartof><rights>2024 The Authors</rights><rights>Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c360t-a21e81a5b854e07019b585c0cc59565a65dac83e4ffa132c1bc9b251f10709cd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0168822724000500$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38341039$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hassanein, Mohamed</creatorcontrib><creatorcontrib>El Naggar, Adel</creatorcontrib><creatorcontrib>Al Sheikh, Abdulrahman</creatorcontrib><creatorcontrib>Djaballah, Khier</creatorcontrib><creatorcontrib>Saeed, Mohamed</creatorcontrib><creatorcontrib>Melas-Melt, Lydie</creatorcontrib><creatorcontrib>AlSifri, Saud</creatorcontrib><title>Safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus from Gulf countries during Ramadan holy month: A subgroup analysis of the SoliRam observational study</title><title>Diabetes research and clinical practice</title><addtitle>Diabetes Res Clin Pract</addtitle><description>•This subanalysis of the SoliRam study was conducted in people with type 2 diabetes mellitus receiving iGlarLixi during Ramadan in Gulf countries.•iGlarLixi was associated with low risk of hypoglycemia, including during Ramadan fasting.•Improvements were observed in HbA1c, FPG and body weight from pre-Ramadan to post-Ramadan.•The benefits of iGlarLixi were seen both during and post-Ramadan.
To investigate safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus (T2DM) observing fast during Ramadan from Gulf countries.
This planned subgroup analysis of the SoliRam – a multinational, prospective, non-interventional, real-world, observational study – focused on participants from Gulf countries. Primary endpoint was proportion of participants experiencing ≥1 episode of severe and/or symptomatic documented (<70 mg/dL [<3.9 mmol/L]) hypoglycemia.
A total of 241 individuals with T2DM (mean age: 58.1 years; male: 54.4%; mean duration of diabetes: 13.3 years) were included. All 234 eligible participants followed during Ramadan were able to fast for ≥25 days and no participants broke fast due to hypoglycemia. Primary endpoint was reported in one participant (0.5%) during fasting hours during Ramadan. Improvements (mean ± SD change) in HbA1c (–1.0 ± 1.0% [–11 ± 10 mmol/mol]), FPG (–22.5 ± 29.7 mg/dL), and body weight (–1.5 ± 2.0 kg) were observed from pre-Ramadan to post-Ramadan. Three participants (1.2 %) reported an adverse event (AE) of any cause and one (0.4%) reported a gastrointestinal AE.
iGlarLixi is an effective and well-tolerated treatment in people with T2DM from Gulf countries, including during Ramadan fasting, and is associated with low risk of hypoglycemia.</description><subject>Adult</subject><subject>Blood Glucose</subject><subject>Diabetes Mellitus, Type 2 - chemically induced</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Fasting - adverse effects</subject><subject>Gulf countries</subject><subject>Humans</subject><subject>Hypoglycemia</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemia - epidemiology</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>iGlarLixi</subject><subject>Islam</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Ramadan fasting</subject><subject>Type 2 diabetes mellitus</subject><issn>0168-8227</issn><issn>1872-8227</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcuO0zAUhiMEYsrAI4DOkk2LL3GasEGjERSkSkgMrC3HPp66SuLiS4c8Fy-IOy1sWdmSv9__Ofqq6jUlK0po826_Mk71AeOKEVavKKWiWT-pFrRds2XL2PpptShc-3i_ql7EuCeENLwWz6sr3vKaEt4tqt93ymKaQU0G0FrUyR1xwhjBW3CbQYWt--XATaBMHlKEB5d2kOYDAoPTBJgwwojD4FKOYIMfYZMHC9rnKQVXHk0ObrqHb2pURk2w88MMo5_S7j3cQMz9ffD5UAZQwxzdY2_aIdz5wZUI-D5iOKrkfAEgpmzml9Uzq4aIry7ndfXj08fvt5-X26-bL7c326XmDUlLxSi2VIm-FTWSNaFdL1qhidaiE41QjTBKtxxraxXlTNNedz0T1NICd9rw6-rt-d9D8D8zxiRHF3VZVU3oc5SsY4JwTlhbUHFGdfAxBrTyENyowiwpkSdfci8vvuTJlzz7Krk3l4rcj2j-pf4KKsCHM4Bl0aPDIKN2OGk0LhRZ0nj3n4o_TKysyw</recordid><startdate>202403</startdate><enddate>202403</enddate><creator>Hassanein, Mohamed</creator><creator>El Naggar, Adel</creator><creator>Al Sheikh, Abdulrahman</creator><creator>Djaballah, Khier</creator><creator>Saeed, Mohamed</creator><creator>Melas-Melt, Lydie</creator><creator>AlSifri, Saud</creator><general>Elsevier B.V</general><scope>6I.</scope><scope>AAFTH</scope><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>202403</creationdate><title>Safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus from Gulf countries during Ramadan holy month: A subgroup analysis of the SoliRam observational study</title><author>Hassanein, Mohamed ; El Naggar, Adel ; Al Sheikh, Abdulrahman ; Djaballah, Khier ; Saeed, Mohamed ; Melas-Melt, Lydie ; AlSifri, Saud</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c360t-a21e81a5b854e07019b585c0cc59565a65dac83e4ffa132c1bc9b251f10709cd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Blood Glucose</topic><topic>Diabetes Mellitus, Type 2 - chemically induced</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Fasting - adverse effects</topic><topic>Gulf countries</topic><topic>Humans</topic><topic>Hypoglycemia</topic><topic>Hypoglycemia - chemically induced</topic><topic>Hypoglycemia - epidemiology</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>iGlarLixi</topic><topic>Islam</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Ramadan fasting</topic><topic>Type 2 diabetes mellitus</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hassanein, Mohamed</creatorcontrib><creatorcontrib>El Naggar, Adel</creatorcontrib><creatorcontrib>Al Sheikh, Abdulrahman</creatorcontrib><creatorcontrib>Djaballah, Khier</creatorcontrib><creatorcontrib>Saeed, Mohamed</creatorcontrib><creatorcontrib>Melas-Melt, Lydie</creatorcontrib><creatorcontrib>AlSifri, Saud</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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>Diabetes research and clinical practice</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hassanein, Mohamed</au><au>El Naggar, Adel</au><au>Al Sheikh, Abdulrahman</au><au>Djaballah, Khier</au><au>Saeed, Mohamed</au><au>Melas-Melt, Lydie</au><au>AlSifri, Saud</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus from Gulf countries during Ramadan holy month: A subgroup analysis of the SoliRam observational study</atitle><jtitle>Diabetes research and clinical practice</jtitle><addtitle>Diabetes Res Clin Pract</addtitle><date>2024-03</date><risdate>2024</risdate><volume>209</volume><spage>111567</spage><epage>111567</epage><pages>111567-111567</pages><artnum>111567</artnum><issn>0168-8227</issn><eissn>1872-8227</eissn><abstract>•This subanalysis of the SoliRam study was conducted in people with type 2 diabetes mellitus receiving iGlarLixi during Ramadan in Gulf countries.•iGlarLixi was associated with low risk of hypoglycemia, including during Ramadan fasting.•Improvements were observed in HbA1c, FPG and body weight from pre-Ramadan to post-Ramadan.•The benefits of iGlarLixi were seen both during and post-Ramadan.
To investigate safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus (T2DM) observing fast during Ramadan from Gulf countries.
This planned subgroup analysis of the SoliRam – a multinational, prospective, non-interventional, real-world, observational study – focused on participants from Gulf countries. Primary endpoint was proportion of participants experiencing ≥1 episode of severe and/or symptomatic documented (<70 mg/dL [<3.9 mmol/L]) hypoglycemia.
A total of 241 individuals with T2DM (mean age: 58.1 years; male: 54.4%; mean duration of diabetes: 13.3 years) were included. All 234 eligible participants followed during Ramadan were able to fast for ≥25 days and no participants broke fast due to hypoglycemia. Primary endpoint was reported in one participant (0.5%) during fasting hours during Ramadan. Improvements (mean ± SD change) in HbA1c (–1.0 ± 1.0% [–11 ± 10 mmol/mol]), FPG (–22.5 ± 29.7 mg/dL), and body weight (–1.5 ± 2.0 kg) were observed from pre-Ramadan to post-Ramadan. Three participants (1.2 %) reported an adverse event (AE) of any cause and one (0.4%) reported a gastrointestinal AE.
iGlarLixi is an effective and well-tolerated treatment in people with T2DM from Gulf countries, including during Ramadan fasting, and is associated with low risk of hypoglycemia.</abstract><cop>Ireland</cop><pub>Elsevier B.V</pub><pmid>38341039</pmid><doi>10.1016/j.diabres.2024.111567</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0168-8227 |
| ispartof | Diabetes research and clinical practice, 2024-03, Vol.209, p.111567-111567, Article 111567 |
| issn | 0168-8227 1872-8227 |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Adult Blood Glucose Diabetes Mellitus, Type 2 - chemically induced Diabetes Mellitus, Type 2 - drug therapy Fasting - adverse effects Gulf countries Humans Hypoglycemia Hypoglycemia - chemically induced Hypoglycemia - epidemiology Hypoglycemic Agents - adverse effects iGlarLixi Islam Male Middle Aged Prospective Studies Ramadan fasting Type 2 diabetes mellitus |
| title | Safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus from Gulf countries during Ramadan holy month: A subgroup analysis of the SoliRam observational study |
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