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Real-World Evaluation of Once-Weekly Subcutaneous Semaglutide in Patients with Type 2 Diabetes Mellitus in Spain (SEMA-RW Study)
Open accessAbstract
Although, in randomized clinical trials, once-weekly subcutaneous semaglutide (OW s.c.) has demonstrated superior efficacy in comparison with placebo and active controls in terms of glycemic control and body weight reduction in patients with type 2 diabetes mellitus (T2DM), these results need to be confirmed in a real-world (RW) setting. An RW ambispective study (6 months retrospective and 6 months prospective) was conducted in 10 tertiary hospitals in Spain. We evaluated changes in HbA1c and body weight in patients with T2DM treated with semaglutide OW s.c. Additionally, we analyzed different subgroups of patients treated with semaglutide OW s.c. as an add-on to glucose-lowering therapy. A total of 752 patients with a mean age of 60.2 years, a mean HbA1c level of 8.5%, a mean body weight of 101.6 kg, and a mean T2DM duration of 10 years were included. At 12 months, compared with baseline, there was a mean difference of −2.1% in HbA1c levels (p < 0.001) and a mean difference of 9.2 kg in body weight (p < 0.001). Moreover, there were statistically significant differences (p < 0.001) between baseline and month 12 in both HbA1c and body weight in the four subgroups receiving semaglutide OW s.c. as an add-on to glucose-lowering therapy. Semaglutide OW s.c. was well tolerated, with gastrointestinal disorders being the most commonly reported side effects. In this RW study, 12 months of treatment with semaglutide OW s.c. in patients with T2DM was associated with significant and clinically relevant improvements in glycemic control and weight loss, regardless of the glucose-lowering therapy received, and the overall safety profile was positive.
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Selection bias is a frequent concern in real-world studies of GLP-1RA that only include 'drug survivors' (those retaining treatment over a prolonged period) or that restrict analyses to high-dose users.
“Areas of particular focus are how to avoid selection bias, which is a frequent concern in studies that only include ‘drug survivors’, 53 , 55 , 58 , 60 , 61 , 62 , 65 , 67 , 70 , 71 that is, those retaining treatment over a prolonged period, or those restricting their analyses to high‐dose users. 57”
From Real‐world evidence on the utilization, clinical and comparative effectiveness, and adverse effects of newer GLP ‐ 1RA ‐based weight‐loss therapies (2025) · cites this paper as [62]
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Cited by
Sorted by citations
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Metadata
- Authors
- Caballero Mateos, I., García de Lucas, M. D., Doulatram-Gamgaram, V. K., Moreno-Moreno, P., Jimenez-Millan, A. I., Botana-López, M., Merino-Torres, J. F., Soto-Gónzalez, A., Fernández-García, J. C., & Morales-Portillo, C.
- Affiliations
- Endocrinology and Nutrition Department, Virgen Macarena University Hospital and Vithas Hospital, 41009 Sevilla, Spain
- Internal Medicine Department, Hospital Costa del Sol, 29603 Marbella, Spain
- Department of Endocrinology and Nutrition, Regional University Hospital of Malaga, Biomedical Research Institute of Malaga (IBIMA), Faculty of Medicine, University of Malaga, 29016 Malaga, Spain
- Hospital Universitario Reina Sofía (ES)
- Endocrinology and Nutrition Department, University Hospital, 11510 Puerto Real, Spain
- Hospital Universitario Lucus Augusti (ES)
- Hospital Universitari i Politècnic La Fe (ES)
- Endocrinology and Nutrition Department, A Coruña University Hospital Complex, 15006 A Coruña, Spain
- ORCID
- Venue
- Nutrients
- Publisher
- MDPI AG
- Published
- 2024-08-03
- Volume
- 16
- Issue
- 15
- Pages
- 2545
- ISSN
- 2072-6643 (ISSN-L)
- PMC
- PMC11314012
- OpenAlex
- W4401330181
- Cited by
- 8
- References
- 9
- Citations by year
- 2026: 4 · 2025: 4
- FWCI
- 2.63
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Nutrients (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Repository of Digital Objects for Teaching Research and Culture (University of Valencia) (submittedVersion, cc-by-nc)
- Funders
- ISCIII (INT21/00078)
- 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 (medical) › Pharmacology and Obesity Treatment
- Keywords
- semaglutide, type 2 diabetes, glycemic control, HbA1c, weight loss, GLP-1 receptor agonists, real-world evidence, drug safety, gastrointestinal adverse effects
- MeSH terms
- Glycemic Control, Semaglutide, Aged, Blood Glucose, Body Weight, Diabetes Mellitus, Type 2, Drug Administration Schedule, Glucagon-Like Peptides, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Injections, Subcutaneous, Male, Middle Aged, Prospective Studies, Retrospective Studies, Spain, Weight Loss, Treatment Outcome
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