PubMed:24117597 JSONTXT

{"project":"PubmedHPO","denotations":[{"id":"T1","span":{"begin":282,"end":299},"obj":"HP_0000819"}],"text":"Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1).\nAIMS: To assess the efficacy and safety of one- and two-step dose-increase regimens of lixisenatide once daily in participants with Type 2 diabetes mellitus insufficiently controlled with metformin.\nMETHODS: This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin. Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period. Primary outcome was HbA1c reduction at week 24.\nRESULTS: Lixisenatide one-/two-step once daily significantly improved HbA1c at week 24 compared with placebo (P \u003c 0.0001) and allowed more participants to achieve HbA1c \u003c 53 mmol/mol (\u003c 7.0%) (P ≤ 0.0005). Improvements were observed in fasting plasma glucose (-0.5/-0.6 vs. +0.1 mmol/l; P \u003c 0.001) and body weight (-2.6/-2.7 vs. -1.6 kg; P \u003c 0.005). At week 24, adverse events were reported by 67.7/70.8/65.6% of participants treated with lixisenatide one-/two-step/placebo, respectively--nausea and vomiting being reported most frequently. Symptomatic hypoglycaemia occurred in 1.9/2.5% of participants on one-/two-step lixisenatide and 0.6% with placebo, with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable double-blind extension period of at least 52 weeks.\nCONCLUSIONS: Lixisenatide one- or two-step dose-increase regimens significantly improved glycaemic control and decreased body weight over 24 weeks and during a long-term extension period without increasing hypoglycaemia. The study confirmed that tolerability in the one-step group was at least similar to the two-step dose increase, with nausea/vomiting and hypoglycaemia frequency being lower in the one-step regimen."}

{"project":"PCI_RCT","denotations":[{"id":"T1","span":{"begin":23,"end":35},"obj":"CI"},{"id":"T2","span":{"begin":74,"end":89},"obj":"DP"},{"id":"T3","span":{"begin":471,"end":486},"obj":"DP"},{"id":"T4","span":{"begin":275,"end":290},"obj":"DP"},{"id":"T5","span":{"begin":641,"end":648},"obj":"CI"},{"id":"T6","span":{"begin":568,"end":580},"obj":"CI"},{"id":"T7","span":{"begin":1447,"end":1459},"obj":"CI"},{"id":"T8","span":{"begin":774,"end":786},"obj":"CI"},{"id":"T9","span":{"begin":230,"end":242},"obj":"CI"},{"id":"T10","span":{"begin":1204,"end":1216},"obj":"CI"},{"id":"T11","span":{"begin":1386,"end":1398},"obj":"CI"},{"id":"T12","span":{"begin":1592,"end":1604},"obj":"CI"},{"id":"T13","span":{"begin":51,"end":58},"obj":"CI"},{"id":"T14","span":{"begin":388,"end":395},"obj":"CI"},{"id":"T15","span":{"begin":866,"end":873},"obj":"CI"},{"id":"T16","span":{"begin":1231,"end":1238},"obj":"CI"},{"id":"T17","span":{"begin":1413,"end":1420},"obj":"CI"}],"text":"Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1).\nAIMS: To assess the efficacy and safety of one- and two-step dose-increase regimens of lixisenatide once daily in participants with Type 2 diabetes mellitus insufficiently controlled with metformin.\nMETHODS: This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin. Participants were randomized to receive either lixisenatide in a one-step dose increase or a two-step dose increase vs. placebo for 24 weeks, followed by a ≥ 52-week variable double blind period. Primary outcome was HbA1c reduction at week 24.\nRESULTS: Lixisenatide one-/two-step once daily significantly improved HbA1c at week 24 compared with placebo (P \u003c 0.0001) and allowed more participants to achieve HbA1c \u003c 53 mmol/mol (\u003c 7.0%) (P ≤ 0.0005). Improvements were observed in fasting plasma glucose (-0.5/-0.6 vs. +0.1 mmol/l; P \u003c 0.001) and body weight (-2.6/-2.7 vs. -1.6 kg; P \u003c 0.005). At week 24, adverse events were reported by 67.7/70.8/65.6% of participants treated with lixisenatide one-/two-step/placebo, respectively--nausea and vomiting being reported most frequently. Symptomatic hypoglycaemia occurred in 1.9/2.5% of participants on one-/two-step lixisenatide and 0.6% with placebo, with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable double-blind extension period of at least 52 weeks.\nCONCLUSIONS: Lixisenatide one- or two-step dose-increase regimens significantly improved glycaemic control and decreased body weight over 24 weeks and during a long-term extension period without increasing hypoglycaemia. The study confirmed that tolerability in the one-step group was at least similar to the two-step dose increase, with nausea/vomiting and hypoglycaemia frequency being lower in the one-step regimen."}