Evidence map›Paper›PMID 22432104›Full record

Trial reportDiabetes care2012

Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono).

Vivian A Fonseca, Ricardo Alvarado-Ruiz, Denis Raccah, Gabor Boka, Patrick Miossec, John E Gerich, EFC6018 GetGoal-Mono Study Investigators

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 91 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 12 pooled it
18.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00688701 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 12-week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents

TypeinterventionalSponsorSanofiRan2008 to 2009Enrolled361ConditionsDiabetes Mellitus, Type 2ArmsLixisenatide (AVE0010), Placebo, Pen auto-injector
NCT02308254 phase1 / phase2unknown statusnot on this mapstarted 2013, after this paper: background citation

Effects of Lixisenatide on Gastric Emptying, Glycaemia and 'Postprandial' Blood Pressure in Type 2 Diabetes and Healthy Subjects.

TypeinterventionalSponsorRoyal Adelaide HospitalRan2013 to 2016Enrolled30ConditionsDiabetes Mellitus, GastroparesisArmsLixisenatide, Placebo
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 12 syntheses or guidelines pooled it, 218 citations in OpenAlex.

  1. Pooled it
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  3. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
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  16. Lixisenatide Reduces Chylomicron Triacylglycerol by Increased Clearance.The Journal of clinical endocrinology and metabolism · 2019
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31 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 3 countries.

Vivian A FonsecaDepartment of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, USA. vfonseca@tulane.edu
Ricardo Alvarado-Ruiz
Denis Raccah
Gabor Boka
Patrick Miossec
John E Gerich
EFC6018 GetGoal-Mono Study Investigators
Sanofi (France) · FRDurango Institute of Technology · MXHôpital Sainte-Marguerite · FRTulane University · USUniversity of Rochester · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess efficacy and safety of lixisenatide monotherapy in type 2 diabetes. RESEARCH DESIGN AND

methodsRandomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy (HbA(1c) 7-10%) allocated to one of four once-daily subcutaneous dose increase regimens: lixisenatide 2-step (10 μg for 1 week, 15 μg for 1 week, and then 20 μg; n = 120), lixisenatide 1-step (10 μg for 2 weeks and then 20 μg; n = 119), placebo 2-step (n = 61), or placebo 1-step (n = 61) (placebo groups were combined for analyses). Primary end point was HbA(1c) change from baseline to week 12.

resultsOnce-daily lixisenatide significantly improved HbA(1c) (mean baseline 8.0%) in both groups (least squares mean change vs. placebo: -0.54% for 2-step, -0.66% for 1-step; P < 0.0001). Significantly more lixisenatide patients achieved HbA(1c) <7.0% (52.2% 2-step, 46.5% 1-step) and ≤ 6.5% (31.9% 2-step, 25.4% 1-step) versus placebo (26.8% and 12.5%, respectively; P < 0.01). Lixisenatide led to marked significant improvements of 2-h postprandial glucose levels and blood glucose excursions measured during a standardized breakfast test. A significant decrease in fasting plasma glucose was observed in both lixisenatide groups versus placebo. Mean decreases in body weight (∼2 kg) were observed in all groups. The most common adverse events were gastrointestinal-nausea was the most frequent (lixisenatide 23% overall, placebo 4.1%). Symptomatic hypoglycemia occurred in 1.7% of lixisenatide and 1.6% of placebo patients, with no severe episodes. Safety/tolerability was similar for the two dose regimens.

conclusionsOnce-daily lixisenatide monotherapy significantly improved glycemic control with a pronounced postprandial effect (75% reduction in glucose excursion) and was safe and well tolerated in type 2 diabetes.

Indexed as

AdultAgedAged, 80 and overBlood GlucoseBlood Glucose Self-MonitoringBlood PressureBody Mass IndexDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodFemaleGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsBlood GlucoseGlucagon-Like Peptide-2 ReceptorGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentslixisenatidePeptides

Identifiers

PMID22432104
PMCPMC3357248
OpenAlexW2108122035

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.