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.

Aim: To investigate safety and effectiveness of iGlarLixi in adults with type 2 diabetes mellitus (T2DM) observing fast during Ramadan from Gulf countries.
Methods: 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.
Results: 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.
Conclusions: 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.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Mohamed Hassanein reports administrative support, article publishing charges, equipment, drugs, or supplies, statistical analysis, and writing assistance were provided by Sanofi. Adel El Naggar reports administrative support, article publishing charges, equipment, drugs, or supplies, statistical analysis, and writing assistance were provided by Sanofi. Abdulrahman Al Sheikh reports administrative support, article publishing charges, equipment, drugs, or supplies, statistical analysis, and writing assistance were provided by Sanofi. Lydie Melas-Melt reports administrative support, article publishing charges, and writing assistance were provided by Sanofi. Saud AlSifri reports administrative support, article publishing charges, equipment, drugs, or supplies, statistical analysis, and writing assistance were provided by Sanofi. Mohamed Hassanein reports a relationship with Sanofi, Boehringer Ingelheim, and Novo Nordisk that includes: board membership. Mohamed Hassanein reports a relationship with Sanofi, Novo Nordisk, Eli Lilly and Company, Merck Sharp and Dohme, Janssen, and LifeScan that includes: speaking and lecture fees. Adel El Naggar reports a relationship with Sanofi, Novo Nordisk, and Merck & Co that includes: board membership. Adel El Naggar reports a relationship with Sanofi, Novo Nordisk, AstraZeneca, MSD, Organon & Co., Boehringer Ingelheim, Eli Lilly and Company, and Novartis that includes: speaking and lecture fees. Khier Djaballah reports a relationship with Sanofi that includes: employment and equity or stocks. Mohamed Saeed reports a relationship with Sanofi that includes: employment. Lydie Melas-Melt reports a relationship with IVIDATA Life Sciences that includes: employment. Saud AlSifri reports a relationship with Sanofi that includes: board membership. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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