Evidence map›Paper›PMID 28742225›Full record

Trial reportDiabetes, obesity & metabolism2018

Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial.

Wenying Yang, Kyungwan Min, Zhiguang Zhou, Ling Li, XiangJin Xu, Dalong Zhu, A Venkateshwar Rao, Laxminarayanappa Sreenivasa Murthy, Nianxian Zhang, Ivy Li and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01632163 (A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin), which is not on this map. Cited by 21 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 9 pooled it
2.1field-weighted citation impact, top 12% 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.

NCT01632163 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 Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

TypeinterventionalSponsorSanofiRan2012 to 2015Enrolled447ConditionsType 2 Diabetes MellitusArmsLixisenatide (AVE0010), Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 9 syntheses or guidelines pooled it, 32 citations in OpenAlex.

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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

12 authors at 10 institutions in 4 countries.

Wenying YangChina-Japan Friendship Hospital, Beijing, China.
Kyungwan MinEulji General Hospital, Seoul, South Korea.
Zhiguang ZhouThe Second Xiangya Hospital of Central South University, Changsha, China.
Ling LiShengjing Hospital of China Medical University, Shenyang, China.
XiangJin XuFuzhou General Hospital, Fuzhou, China.
Dalong ZhuNanjing Gulou Hospital, Nanjing, China.
A Venkateshwar RaoMaxCure Hospital, Hyderabad, India.
Laxminarayanappa Sreenivasa MurthyCauvery Medical Centre, Bengaluru, India.
Nianxian ZhangSanofi, Shanghai, China.
Ivy LiSanofi, Shanghai, China.
Elisabeth NiemoellerDiabetes Division, Sanofi, Frankfurt, Germany.
Shuhua ShangSanofi, Shanghai, China.
Sanofi (China) · CNBangalore Diabetes Centre · INCentral South University · CNChina-Japan Friendship Hospital · CNChina Medical University · CNEulji General Hospital · KRFuzhou General Hospital of Nanjing Military Command · CNMaxCure Hospitals · INNanjing Traditional Chinese Medicine Hospital · CNSanofi (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess the effects on glycaemic control of lixisenatide vs placebo as add-on treatment to basal insulin (BI) ± metformin and effects on glycated haemoglobin (HbA1c) reduction in patients with insufficiently controlled type 2 diabetes (T2D).

methodsPatients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L). The primary endpoint was absolute change in HbA1c from baseline to week 24. Secondary efficacy endpoints included: percentage of responders; changes in 2-hour postprandial plasma glucose (PPG); 7-point SMPG (daily average); body weight (BW); total daily BI dose; fasting plasma glucose; and safety assessments.

resultsBaseline demographics were similar in the two treatment groups. After insulin optimization during run-in, lixisenatide was superior to placebo in mean change from baseline (7.9% [standard deviation {s.d.}, 0.66] and 7.9% [0.70], respectively) to week 24 in HbA1c (least squares mean [standard error {s.e.}] change -0.62% [0.09] vs -0.11% [0.09]; P < .0001, respectively) and higher proportions of patients achieved HbA1c targets. Two-hour PPG, daily mean SMPG and mean BW were reduced further and daily BI dose was lower with lixisenatide than placebo (-1.12 kg vs 0.04 kg [P < .0001]; -3.0 U vs -1.9 U [P = .0033], respectively). Treatment-emergent adverse events were greater with lixisenatide than placebo (63.8% vs 40.8%, respectively). The incidence of symptomatic hypoglycaemia was similar (lixisenatide 15.6% vs placebo 13.5%).

conclusionsIn Asian patients insufficiently controlled on BI ± metformin, lixisenatide was superior to placebo in glycaemic control, with a tolerability profile in line with other glucagon-like peptide-1 receptor agonists. CLINICAL TRIAL NUMBER: NCT01632163 (clinicaltrials.gov).

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsInsulin ResistanceAdultAsiaBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHyperglycemiaBlood GlucoseGLP1R protein, humanGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like Peptide-2 ReceptorGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinlixisenatidePeptidesGLP-1incretinsincretin therapyrandomized trial

Identifiers

PMID28742225
PMCPMC5813270
OpenAlexW2738799702

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.