PMID- 29159080 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220310 IS - 2214-6237 (Electronic) IS - 2214-6237 (Linking) VI - 1 IP - 2 DP - 2014 Jun TI - 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. PG - 31-37 LID - 10.1016/j.jcte.2014.03.001 [doi] AB - 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 mug 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 (HbA(1c)) <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 HbA(1c) <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 HbA(1c) <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. FAU - Van Gaal, Luc AU - Van Gaal L AD - Antwerp University Hospital, Department of Endocrinology, Diabetology and Metabolic Diseases, Wilrijkstraat 10, B-2650 Edegem, Antwerp, Belgium. FAU - Souhami, Elisabeth AU - Souhami E AD - Sanofi, Paris, France. FAU - Zhou, Tianyue AU - Zhou T AD - Sanofi, Bridgewater, NJ, USA. FAU - Aronson, Ronnie AU - Aronson R AD - LMC Diabetes & Endocrinology, Toronto, Ontario, Canada. LA - eng PT - Journal Article DEP - 20140411 PL - Netherlands TA - J Clin Transl Endocrinol JT - Journal of clinical & translational endocrinology JID - 101629335 PMC - PMC5685032 OTO - NOTNLM OT - AE, adverse event OT - BMI, body mass index OT - Body weight OT - DPP-4, dipeptidyl peptidase-4 OT - FPG, fasting plasma glucose OT - GI, gastrointestinal OT - GLP-1, glucagon-like peptide-1 OT - Glycated hemoglobin (HbA1c) OT - HbA1c, glycated hemoglobin OT - LOCF, last observation carried forward OT - LS, least squares OT - PPG, postprandial plasma glucose OT - Postprandial plasma glucose (PPG) OT - T2DM, type 2 diabetes mellitus OT - TEAE, treatment-emergent adverse event EDAT- 2014/04/11 00:00 MHDA- 2014/04/11 00:01 PMCR- 2014/04/11 CRDT- 2017/11/22 06:00 PHST- 2014/01/08 00:00 [received] PHST- 2014/03/11 00:00 [revised] PHST- 2014/03/23 00:00 [accepted] PHST- 2017/11/22 06:00 [entrez] PHST- 2014/04/11 00:00 [pubmed] PHST- 2014/04/11 00:01 [medline] PHST- 2014/04/11 00:00 [pmc-release] AID - S2214-6237(14)00011-8 [pii] AID - 10.1016/j.jcte.2014.03.001 [doi] PST - epublish SO - J Clin Transl Endocrinol. 2014 Apr 11;1(2):31-37. doi: 10.1016/j.jcte.2014.03.001. eCollection 2014 Jun.