Gastrointestinal adverse events with insulin glargine/lixisenatide fixed‐ratio combination versus glucagon‐like peptide‐1 receptor agonist s in people with type 2 diabetes mellitus: A network meta‐analysis
Open accessAbstract
Aims: Glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) are the recommended first injectable therapy in type 2 diabetes. However, long‐term persistence is suboptimal and partly attributable to gastrointestinal tolerability, particularly during initiation/escalation. Gradual titration of fixed‐ratio combination GLP‐1 RA/insulin therapies may improve GLP‐1 RA gastrointestinal tolerability. We compared gastrointestinal adverse event (AE) rates for iGlarLixi versus GLP‐1 RAs during the first 12 weeks of therapy, including a sensitivity analysis with IDegLira. Materials and methods: The PICO framework was used to identify studies from MEDLINE, EMBASE and CENTRAL searches using a proprietary, web‐based, standardized tool with single data extraction. Gastrointestinal AEs were modelled using a Bayesian network meta‐analysis (NMA), using fixed and random effects for each recommended dose (treatment‐specific NMA) and class (drug‐class NMA). Results: Treatment‐specific NMA included 17 trials (n = 9030; 3665 event‐weeks). Nausea rates were significantly lower with iGlarLixi versus exenatide 10 μg twice daily (rate ratio: 0.32; 95% credible interval: 0.15, 0.66), once‐daily lixisenatide 20 μg (0.35; 0.24, 0.50) and liraglutide 1.8 mg once daily (0.48; 0.23, 0.98). Rates were numerically, but not statistically, lower versus once‐weekly semaglutide 1 mg (0.60; 0.30, 1.23) and dulaglutide 1.5 mg (0.60; 0.29, 1.26), and numerically, but not statistically, higher versus once‐weekly exenatide (1.91; 0.91, 4.03). Sensitivity analysis results were similar. In a naïve, pooled analysis, vomiting was lower with iGlarLixi versus other GLP‐1 RAs. Conclusions: During the first 12 weeks of treatment, iGlarLixi was generally associated with less nausea and vomiting than single‐agent GLP‐1 RAs. Enhanced gastrointestinal tolerability with fixed‐ratio combinations may favour treatment persistence.
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The findings are consistent with prior research in diabetic populations.
“Nausea was the most frequently reported symptom, besides vomiting and diarrhea, findings consistent with prior research in diabetic populations [51–56].”
From Gastrointestinal adverse events associated with GLP-1 RA in non-diabetic patients with overweight or obesity: a systematic review and network meta-analysis (2025) · cites this paper as [55]
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Cites
GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus
Meier, J. J. (2012) · Nature Reviews Endocrinology · doi:10.1038/nrendo.2012.140 · Cited by 1,311 · cited 2× · see citing works
“In reviews of clinical trials involving GLP-1 RA therapy, nausea was reported to occur in 24%-60% of participants, vomiting 5%-15% and diarrhoea 9%-20%.(11,12) In a survey of 443 physicians who reported on patient discontinuation of GLP-1 RA therapy in the previous 6 months, nausea/vomiting was considered to be the ca…”
BackgroundDesign of Treatment Trials for Functional Gastrointestinal Disorders
Irvine, E. J., Tack, J., Crowell, M. D., Gwee, K. A., Ke, M., Schmulson, M. J., Whitehead, W. E., & Spiegel, B. (2016) · Gastroenterology · doi:10.1053/j.gastro.2016.02.010 · Cited by 550 · cited 1× · see citing works
“Limitations include both the variability in definitions of GI AEs and the self-reporting of GI AEs, which may be influenced either by the expectation that they will occur (nocebo effect) or by an opinion that one treatment is less likely to cause GI AEs than another (precebo effect).(43) Other limitations include the…”
Hunter, K., & Hölscher, C. (2012) · BMC Neuroscience · doi:10.1186/1471-2202-13-33 · Cited by 504 · see citing works
Ahrén, B., Masmiquel, L., Kumar, H., Sargin, M., Karsbøl, J. D., Jacobsen, S. H., & Chow, F. (2017) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(17)30092-x · Cited by 495 · see citing works
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“GI AEs are known to occur early after initiation of therapy and during treatment escalation.(13,14) Although GI AEs may sometimes persist with long-term use, there is evidence showing that after initiation of exenatide twice daily, the incidence of nausea peaked at weeks 4-6 and declined thereafter, and that after ini…”
BackgroundNauck, M. A., Petrie, J. R., Sesti, G., Mannucci, E., Courrèges, J.-P., Lindegaard, M. L., Jensen, C. B., & Atkin, S. L. (2016) · Diabetes Care · doi:10.2337/dc15-0165 · Cited by 233 · see citing works
Horowitz, M., Aroda, V. R., Han, J., Hardy, E., & Rayner, C. K. (2017) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.12872 · Cited by 79 · see citing works
Self-citationFederici, M. O., McQuillan, J., Biricolti, G., Losi, S., Lebrec, J., Richards, C., Miglio, C., & Norrbacka, K. (2018) · Diabetes Therapy · doi:10.1007/s13300-018-0396-2 · Cited by 37 · cited 1× · see citing works
“Over the entire follow-up, median persistence varied from 73 days with exenatide twice daily to >300 days with dulaglutide.(27) The lack of persistence with GLP-1 RA therapy is thought, at least in part, to be attributable to GI AEs, which are the most frequently”
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Liu, L., Chen, J., Wang, L., Chen, C., & Chen, L. (2022) · Frontiers in Endocrinology · doi:10.3389/fendo.2022.1043789 · Cited by 258 · see citing works
Ismaiel, A., Scarlata, G. G. M., Boitos, I., Leucuta, D.-C., Popa, S.-L., Al Srouji, N., Abenavoli, L., & Dumitrascu, D. L. (2025) · International Journal of Obesity · doi:10.1038/s41366-025-01859-6 · Cited by 99 · see citing works
- Authors
- Rayner, C. K., Wu, T., Aroda, V. R., Whittington, C., Kanters, S., Guyot, P., Shaunik, A., & Horowitz, M.
- Affiliations
- The University of Adelaide (AU)
- Brigham and Women's Hospital (US)
- Doctor Evidence Santa Monica California USA
- Sanofi (France) (FR)
- Sanofi (United States) (US)
- Corresponding author
- Rayner, Christopher K.
- ORCID
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2020-10-22
- Volume
- 23
- Issue
- 1
- Pages
- 136-146
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- PMC
- PMC7756611
- OpenAlex
- W3089552518
- Cited by
- 23
- References
- 9
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 4 · 2023: 3 · 2022: 4 · 2021: 4 · 2020: 1
- FWCI
- 2.26
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Obesity and Metabolism (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Sanofi
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- iGlarLixi, GLP-1 receptor agonists, type 2 diabetes, gastrointestinal adverse effects, nausea, vomiting, exenatide, liraglutide, semaglutide, dulaglutide, fixed-ratio combination therapy, treatment tolerability
- MeSH terms
- Glucagon-Like Peptide-1 Receptor, Glucagon-Like Peptide-2 Receptor, Insulin Glargine, Network Meta-Analysis, Bayes Theorem, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Peptides
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