Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (<50 years) obese patients with type 2 diabetes mellitus
Objective: To compare the efficacy and safety of the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide with the dipeptidyl peptidase-4 inhibitor sitagliptin in patients aged <50 years affected by obesity and type 2 diabetes mellitus (T2DM). Materials and methods: This was...
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| Format: | Article |
| Language: | English |
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Elsevier
2014-06-01
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| Series: | Journal of Clinical & Translational Endocrinology |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2214623714000118 |
| _version_ | 1828973748484571136 |
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| author | Luc Van Gaal Elisabeth Souhami Tianyue Zhou Ronnie Aronson |
| author_facet | Luc Van Gaal Elisabeth Souhami Tianyue Zhou Ronnie Aronson |
| author_sort | Luc Van Gaal |
| collection | DOAJ |
| description | Objective: To compare the efficacy and safety of the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide with the dipeptidyl peptidase-4 inhibitor sitagliptin in patients aged <50 years affected by obesity and type 2 diabetes mellitus (T2DM).
Materials and methods: This was a 24-week, double-blind, randomized, parallel-group study. Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20 μg once-daily injection (n = 158) or once-daily oral sitagliptin 100 mg (n = 161). The primary endpoint was the proportion of patients with a glycated hemoglobin (HbA1c) <7% and ≥5% weight loss at 24 weeks.
Results: The proportion of patients that achieved the primary endpoint was 12.0% for lixisenatide versus 7.5% for sitagliptin; weighted average of proportion difference: 4.6%, p = 0.1696). A total of 40.7% of patients achieved HbA1c <7% with lixisenatide versus 40.0% with sitagliptin. Lixisenatide produced greater reductions in body weight (LS mean difference: −1.3 kg, p = 0.0006) and postprandial plasma glucose after a standardized meal test (LS mean difference: −34.4 mg/dL [−1.9 mmol/L], p = 0.0001) versus sitagliptin. There was a similar incidence of treatment-emergent adverse events (63.9% vs. 60.9%) and serious treatment-emergent adverse events (1.9% vs. 1.9%), with low rates of symptomatic hypoglycemia (0.6% vs. 1.9%) for lixisenatide and sitagliptin, respectively, and no cases of severe hypoglycemia.
Conclusion: In obese patients aged <50 years with T2DM, the proportion of patients with an HbA1c <7% with weight loss ≥5% was similar between groups. Lixisenatide, however, resulted in significantly greater reductions in body weight and postprandial plasma glucose excursions than sitagliptin. Tolerability was similar between groups. |
| first_indexed | 2024-12-14T13:50:42Z |
| format | Article |
| id | doaj.art-74aa8d68fbc84b3cae3cc7f257f99b95 |
| institution | Directory Open Access Journal |
| issn | 2214-6237 |
| language | English |
| last_indexed | 2024-12-14T13:50:42Z |
| publishDate | 2014-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Clinical & Translational Endocrinology |
| spelling | doaj.art-74aa8d68fbc84b3cae3cc7f257f99b952022-12-21T22:59:07ZengElsevierJournal of Clinical & Translational Endocrinology2214-62372014-06-0112313710.1016/j.jcte.2014.03.001Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (<50 years) obese patients with type 2 diabetes mellitusLuc Van Gaal0Elisabeth Souhami1Tianyue Zhou2Ronnie Aronson3Antwerp University Hospital, Department of Endocrinology, Diabetology and Metabolic Diseases, Wilrijkstraat 10, B-2650 Edegem, Antwerp, BelgiumSanofi, Paris, FranceSanofi, Bridgewater, NJ, USALMC Diabetes & Endocrinology, Toronto, Ontario, CanadaObjective: To compare the efficacy and safety of the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide with the dipeptidyl peptidase-4 inhibitor sitagliptin in patients aged <50 years affected by obesity and type 2 diabetes mellitus (T2DM). Materials and methods: This was a 24-week, double-blind, randomized, parallel-group study. Obese patients with T2DM inadequately controlled on metformin were randomized to lixisenatide 20 μg once-daily injection (n = 158) or once-daily oral sitagliptin 100 mg (n = 161). The primary endpoint was the proportion of patients with a glycated hemoglobin (HbA1c) <7% and ≥5% weight loss at 24 weeks. Results: The proportion of patients that achieved the primary endpoint was 12.0% for lixisenatide versus 7.5% for sitagliptin; weighted average of proportion difference: 4.6%, p = 0.1696). A total of 40.7% of patients achieved HbA1c <7% with lixisenatide versus 40.0% with sitagliptin. Lixisenatide produced greater reductions in body weight (LS mean difference: −1.3 kg, p = 0.0006) and postprandial plasma glucose after a standardized meal test (LS mean difference: −34.4 mg/dL [−1.9 mmol/L], p = 0.0001) versus sitagliptin. There was a similar incidence of treatment-emergent adverse events (63.9% vs. 60.9%) and serious treatment-emergent adverse events (1.9% vs. 1.9%), with low rates of symptomatic hypoglycemia (0.6% vs. 1.9%) for lixisenatide and sitagliptin, respectively, and no cases of severe hypoglycemia. Conclusion: In obese patients aged <50 years with T2DM, the proportion of patients with an HbA1c <7% with weight loss ≥5% was similar between groups. Lixisenatide, however, resulted in significantly greater reductions in body weight and postprandial plasma glucose excursions than sitagliptin. Tolerability was similar between groups.http://www.sciencedirect.com/science/article/pii/S2214623714000118Glycated hemoglobin (HbA1c)Body weightPostprandial plasma glucose (PPG) |
| spellingShingle | Luc Van Gaal Elisabeth Souhami Tianyue Zhou Ronnie Aronson Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (<50 years) obese patients with type 2 diabetes mellitus Journal of Clinical & Translational Endocrinology Glycated hemoglobin (HbA1c) Body weight Postprandial plasma glucose (PPG) |
| title | Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (<50 years) obese patients with type 2 diabetes mellitus |
| title_full | Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (<50 years) obese patients with type 2 diabetes mellitus |
| title_fullStr | Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (<50 years) obese patients with type 2 diabetes mellitus |
| title_full_unstemmed | Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (<50 years) obese patients with type 2 diabetes mellitus |
| title_short | Efficacy and safety of the glucagon-like peptide-1 receptor agonist lixisenatide versus the dipeptidyl peptidase-4 inhibitor sitagliptin in young (<50 years) obese patients with type 2 diabetes mellitus |
| title_sort | efficacy and safety of the glucagon like peptide 1 receptor agonist lixisenatide versus the dipeptidyl peptidase 4 inhibitor sitagliptin in young 50 years obese patients with type 2 diabetes mellitus |
| topic | Glycated hemoglobin (HbA1c) Body weight Postprandial plasma glucose (PPG) |
| url | http://www.sciencedirect.com/science/article/pii/S2214623714000118 |
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