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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.
J Clin Transl Endocrinol. 2014 Jun; 1(2):31-37.JC

Abstract

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.

Authors+Show Affiliations

Antwerp University Hospital, Department of Endocrinology, Diabetology and Metabolic Diseases, Wilrijkstraat 10, B-2650 Edegem, Antwerp, Belgium.Sanofi, Paris, France.Sanofi, Bridgewater, NJ, USA.LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29159080

Citation

Van Gaal, Luc, et al. "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, vol. 1, no. 2, 2014, pp. 31-37.
Van Gaal L, Souhami E, Zhou T, et al. 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. 2014;1(2):31-37.
Van Gaal, L., Souhami, E., Zhou, T., & Aronson, R. (2014). 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, 1(2), 31-37. https://doi.org/10.1016/j.jcte.2014.03.001
Van Gaal L, et al. 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. 2014;1(2):31-37. PubMed PMID: 29159080.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Van Gaal,Luc, AU - Souhami,Elisabeth, AU - Zhou,Tianyue, AU - Aronson,Ronnie, Y1 - 2014/04/11/ PY - 2014/01/08/received PY - 2014/03/11/revised PY - 2014/03/23/accepted PY - 2017/11/22/entrez PY - 2014/4/11/pubmed PY - 2014/4/11/medline KW - AE, adverse event KW - BMI, body mass index KW - Body weight KW - DPP-4, dipeptidyl peptidase-4 KW - FPG, fasting plasma glucose KW - GI, gastrointestinal KW - GLP-1, glucagon-like peptide-1 KW - Glycated hemoglobin (HbA1c) KW - HbA1c, glycated hemoglobin KW - LOCF, last observation carried forward KW - LS, least squares KW - PPG, postprandial plasma glucose KW - Postprandial plasma glucose (PPG) KW - T2DM, type 2 diabetes mellitus KW - TEAE, treatment-emergent adverse event SP - 31 EP - 37 JF - Journal of clinical & translational endocrinology VL - 1 IS - 2 N2 - 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. SN - 2214-6237 UR - https://www.unboundmedicine.com/medline/citation/29159080/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2214-6237(14)00011-8 DB - PRIME DP - Unbound Medicine ER -
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