Efficacy and safety of lixisenatide once daily vs. placebo in people with type 2 diabetes insufficiently controlled on metformin (GetGoal-F1)
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Aims: To assess the efficacy and safety of one‐ and two‐step dose‐increase regimens of lixisenatide once daily in participants with Type 2 diabetes mellitus insufficiently controlled with metformin. Methods: This was a randomized, double‐blind, placebo‐controlled, parallel‐group, multi‐centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin. Participants were randomized to receive either lixisenatide in a one‐step dose increase or a two‐step dose increase vs. placebo for 24 weeks, followed by a ≥ 52‐week variable double blind period. Primary outcome was HbA 1c reduction at week 24. Results: Lixisenatide one‐/two‐step once daily significantly improved HbA 1c at week 24 compared with placebo (P < 0.0001) and allowed more participants to achieve HbA 1c < 53 mmol/mol (< 7.0%) (P ≤ 0.0005). Improvements were observed in fasting plasma glucose (–0.5/–0.6 vs. +0.1 mmol/l; P < 0.001) and body weight (–2.6/–2.7 vs. –1.6 kg; P < 0.005). At week 24, adverse events were reported by 67.7/70.8/65.6% of participants treated with lixisenatide one‐/two‐step/placebo, respectively—nausea and vomiting being reported most frequently. Symptomatic hypoglycaemia occurred in 1.9/2.5% of participants on one‐/two‐step lixisenatide and 0.6% with placebo, with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable double‐blind extension period of at least 52 weeks. Conclusions: Lixisenatide one‐ or two‐step dose‐increase regimens significantly improved glycaemic control and decreased body weight over 24 weeks and during a long‐term extension period without increasing hypoglycaemia. The study confirmed that tolerability in the one‐step group was at least similar to the two‐step dose increase, with nausea/vomiting and hypoglycaemia frequency being lower in the one‐step regimen.
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GetGoal-S subanalysis found LIXI significantly reduced body weight (−1.76 ± 0.20 kg; -1.12 kg; -2.6/2.7 kg).
“In GetGoal-S, a subanalysis of GetGoal-S and GetGoal-F1 studies, they found that LIXI could significantly reduce subjects’ body weight (− 1.76 ± 0.20 kg;-1.12 kg; -2.6/2.7 kg), respectively (72–74).”
From GLP−1 receptor agonists for the treatment of obesity: Role as a promising approach (2023) · cites this paper as [73]
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- Authors
- Bolli, G. B., Munteanu, M., Dotsenko, S., Niemoeller, E., Boka, G., Wu, Y., & Hanefeld, M.
- Affiliations
- University of Perugia (IT)
- Victor Babeș University of Medicine and Pharmacy Timișoara (RO)
- Zaporizhzhia State Medical and Pharmaceutical University (UA)
- Sanofi (Germany) (DE)
- Sanofi (France) (FR)
- Sanofi (United States) (US)
- Centre for Clinical Studies GWT‐TUD GmbH Dresden Germany
- Corresponding author
- Bolli, G. B.
- Venue
- Diabetic Medicine
- Publisher
- Wiley
- Published
- 2013-10-24
- Volume
- 31
- Issue
- 2
- Pages
- 176-184
- ISSN
- 0742-3071 (ISSN-L)
- 1464-5491
- OpenAlex
- W2003415509
- Cited by
- 144
- References
- 21
- Citations by year
- 2026: 6 · 2025: 11 · 2024: 4 · 2023: 7 · 2022: 4 · 2021: 5 · 2020: 6 · 2019: 6 · 2018: 9 · 2017: 16 · 2016: 21 · 2015: 10 · 2014: 23 · 2013: 15 · 2012: 1
- FWCI
- 18.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetic Medicine (publishedVersion)
- PubMed (publishedVersion)
- 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
- lixisenatide, type 2 diabetes, GLP-1 receptor agonists, HbA1c reduction, dose escalation, glycemic control, weight loss, hypoglycemia, nausea and vomiting, long-term tolerability
- MeSH terms
- Glucagon-Like Peptide-2 Receptor, Adult, Aged, Diabetes Mellitus, Type 2, Drug Administration Schedule, Female, Humans, Hypoglycemic Agents, Male, Metformin, Middle Aged, Peptides, Placebos, Treatment Outcome, Treatment Failure, Young Adult
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