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
Authors' conclusion
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.
Study context
- Population
- Adults with T2D observing fast during Ramadan, Gulf countries; mean age 58.1 years, 54.4% male, mean diabetes duration 13.3 years234 eligible followed in Ramadan
- Participants
- 241 adults
- Primary endpoint
- Proportion of participants with ≥1 episode of severe and/or symptomatic documented (<70 mg/dL [<3.9 mmol/L]) hypoglycemia
- Follow-up
- Fasting hours during Ramadan
Methodological detailsplanned subgroup analysis, multinational, non-interventional, real-world
- Planned subgroup analysis
- Multinational
- Non-interventional
- Real-world
Primary result
As reported in the abstract
≥1 episode of severe and/or symptomatic documented (<70 mg/dL [<3.9 mmol/L]) hypoglycemia during fasting hours · Ramadan
Participants with primary endpoint during fasting hours during Ramadan
1
0.5%
Further findings
Fasting during Ramadan
- Participants who broke fast due to hypoglycemia
- 0
- All 234 eligible participants fasted ≥25 days
HbA1c change · pre- to post-Ramadan
- Mean ± SD change in HbA1c
- −1.0 ± 1.0% [−11 ± 10 mmol/mol]
FPG change · pre- to post-Ramadan
- Mean ± SD change in FPG
- −22.5 ± 29.7 mg/dL
Body weight change · pre- to post-Ramadan
- Mean ± SD change in body weight
- −1.5 ± 2.0 kg
Safety
Adverse events
- Adverse event (AE) of any cause
- 3 (1.2 %)
- Gastrointestinal AE
- 1 (0.4%)
Original publication
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. Diabetes Res Clin Pract. Published 9 February 2024. doi:10.
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