TY  - BOOK
AU  - Ratner, Robert E
TI  - Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S)
SN  - 1056-8727
PY  - 2014///
KW  - *Blood Glucose/me [Metabolism]
KW  - *Diabetes Mellitus, Type 2/dt [Drug Therapy]
KW  - *Hypoglycemia/pc [Prevention & Control]
KW  - *Metformin/tu [Therapeutic Use]
KW  - *Peptides/tu [Therapeutic Use]
KW  - *Postprandial Period
KW  - *Sulfonylurea Compounds/tu [Therapeutic Use]
KW  - Adult
KW  - Aged
KW  - Diabetes Mellitus, Type 2/bl [Blood]
KW  - Dose-Response Relationship, Drug
KW  - Double-Blind Method
KW  - Drug Therapy, Combination
KW  - Female
KW  - Glucagon/bl [Blood]
KW  - Hemoglobin A, Glycosylated/me [Metabolism]
KW  - Humans
KW  - Hypoglycemia/bl [Blood]
KW  - Hypoglycemic Agents/tu [Therapeutic Use]
KW  - Insulin/bl [Blood]
KW  - Internationality
KW  - Male
KW  - Middle Aged
KW  - Treatment Outcome
KW  - MedStar Health Research Institute
KW  - Clinical Trial, Phase III
KW  - Journal Article
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N2  - AIMS: To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) +/- metformin; CONCLUSIONS: Once-daily lixisenatide significantly improved glycemic control, with a pronounced postprandial effect, without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over 24 weeks.Copyright � 2014 The Authors. Published by Elsevier Inc. All rights reserved; METHODS: In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 mug once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs +/- metformin. Primary outcome was change in HbA1c from baseline to Week 24; RESULTS: Lixisenatide provided a significant reduction in HbA1c at Week 24 versus placebo (LS mean: -0.85% vs. -0.10%; p<0.0001) and more patients achieved HbA1c <7.0% (36.4% vs. 13.5%; p<0.0001). Lixisenatide significantly lowered FPG and body weight versus placebo. In breakfast meal test patients, lixisenatide reduced 2-hour PPG versus placebo (LS mean: -111.48 vs. -3.80 mg/dL [-6.19 vs. -0.21 mmol/L]; p<0.0001) and glucose excursion (-94.11 vs. +6.24 mg/dL [-5.22 vs. +0.35 mmol/L]), and reduced 2-hour glucagon, insulin, proinsulin, and C-peptide. The percentage of AEs was 68.3% for lixisenatide and 61.1% for placebo; and for SAEs: 3.5% versus 5.6%, respectively. Lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo (15.3% vs. 12.3%, respectively); one severe episode of hypoglycemia was reported with lixisenatide
UR  - http://dx.doi.org/10.1016/j.jdiacomp.2014.01.012
ER  -