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).
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).
- 2014
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.
English
1056-8727
*Blood Glucose/me [Metabolism]
*Diabetes Mellitus, Type 2/dt [Drug Therapy]
*Hypoglycemia/pc [Prevention & Control]
*Metformin/tu [Therapeutic Use]
*Peptides/tu [Therapeutic Use]
*Postprandial Period
*Sulfonylurea Compounds/tu [Therapeutic Use]
Adult
Aged
Diabetes Mellitus, Type 2/bl [Blood]
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Female
Glucagon/bl [Blood]
Hemoglobin A, Glycosylated/me [Metabolism]
Humans
Hypoglycemia/bl [Blood]
Hypoglycemic Agents/tu [Therapeutic Use]
Insulin/bl [Blood]
Internationality
Male
Middle Aged
Treatment Outcome
MedStar Health Research Institute
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
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.
English
1056-8727
*Blood Glucose/me [Metabolism]
*Diabetes Mellitus, Type 2/dt [Drug Therapy]
*Hypoglycemia/pc [Prevention & Control]
*Metformin/tu [Therapeutic Use]
*Peptides/tu [Therapeutic Use]
*Postprandial Period
*Sulfonylurea Compounds/tu [Therapeutic Use]
Adult
Aged
Diabetes Mellitus, Type 2/bl [Blood]
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Female
Glucagon/bl [Blood]
Hemoglobin A, Glycosylated/me [Metabolism]
Humans
Hypoglycemia/bl [Blood]
Hypoglycemic Agents/tu [Therapeutic Use]
Insulin/bl [Blood]
Internationality
Male
Middle Aged
Treatment Outcome
MedStar Health Research Institute
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't