Evidence map›Paper›PMID 22564709›Full record

Trial reportDiabetes, obesity & metabolism2012

Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia).

Y Seino, K W Min, E Niemoeller, A Takami, EFC10887 GETGOAL-L Asia Study Investigators

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00866658 (A Randomized, Double-Blind, Placebo-Controlled, 2-arm Parallel-group, Multicenter Study With a 24-Week Treatment Period Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Sulfonylurea), which is not on this map. Cited by 123 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
123citing papers in PubMed, 21 pooled it
20.7field-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.

NCT00866658 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, 2-arm Parallel-group, Multicenter Study With a 24-Week Treatment Period Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Sulfonylurea

TypeinterventionalSponsorSanofiRan2009 to 2010Enrolled311ConditionsDiabetes Mellitus, Type 2ArmsLixisenatide (AVE0010), Placebo, Pen auto-injector, Sulfonylurea, Basal Insulin
3 · Its place in the literature

Who cites it

123 citing papers in PubMed, 21 syntheses or guidelines pooled it, 252 citations in OpenAlex.

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63 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

5 authors at 4 institutions in 3 countries.

Y SeinoKansai Electric Power Hospital, Osaka, Japan. seino.yutaka@e2.kepco.co.jp
K W Min
E Niemoeller
A Takami
EFC10887 GETGOAL-L Asia Study Investigators
Eulji General Hospital · KRKansai Electric Power Hospital · JPSanofi (Germany) · DESanofi (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess the efficacy and safety of once-daily lixisenatide versus placebo in Asian patients with type 2 diabetes insufficiently controlled on basal insulin ± sulfonylurea.

methodsIn this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily. The primary endpoint was HbA(1c) change from baseline to week 24.

resultsOnce-daily lixisenatide significantly improved HbA(1c) versus placebo (LS mean difference vs. placebo = -0.88% [95%CI= -1.116, -0.650]; p < 0.0001), and allowed more patients to achieve HbA(1c) <7.0% (35.6 vs. 5.2%) and ≤ 6.5% (17.8 vs. 1.3%). Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose. Lixisenatide was well tolerated; 86% of patients on lixisenatide completed the study versus 92% on placebo. Ten (6.5%) lixisenatide and 9 (5.7%) placebo patients experienced serious adverse events. More lixisenatide patients [14 (9.1%)] discontinued for adverse events versus placebo [5 (3.2%)], mainly with gastrointestinal causes. Nausea and vomiting were reported in 39.6 and 18.2% of patients on lixisenatide versus 4.5 and 1.9% on placebo. Symptomatic hypoglycaemia was more frequent with lixisenatide (42.9%) versus placebo (23.6%), but was similar between groups (32.6 vs. 28.3%, respectively), in those not receiving sulfonylureas. No severe hypoglycaemia was reported.

conclusionsIn an Asian type 2 diabetes population insufficiently controlled by basal insulin  ±  sulfonylurea, once-daily lixisenatide significantly improved glycaemic control, with a pronounced postprandial effect, and was well tolerated.

Indexed as

Asian PeopleAdolescentAdultAgedAged, 80 and overBlood GlucoseBody Mass IndexDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinBlood GlucoseGLP1R protein, humanGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-2 ReceptorGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinlixisenatidePeptidesReceptors, GlucagonSulfonylurea Compounds

Identifiers

PMID22564709
PMCPMC3466411
OpenAlexW1584571461

What Socratic holds

Textmetadata
LicenceCC BY
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.