Evidence map›Paper›PMID 23564915›Full record

Trial reportDiabetes care2013

Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1).

Matthew C Riddle, Thomas Forst, Ronnie Aronson, Leobardo Sauque-Reyna, Elisabeth Souhami, Louise Silvestre, Lin Ping, Julio Rosenstock

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

Trial report in Diabetes care, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00975286. Cited by 118 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
118citing papers in PubMed, 18 pooled it
26.2field-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.

NCT00975286 phase3completed

A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin

Ran2009Enrolled446Registered outcomes13Posted comparisons1ConditionsType 2 Diabetes MellitusArmsInsulin glargine, Lixisenatide (AVE0010), Metformin, Pen auto-injector, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

118 citing papers in PubMed, 18 syntheses or guidelines pooled it, 250 citations in OpenAlex.

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58 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

8 authors at 6 institutions in 4 countries.

Matthew C RiddleOregon Health and Science University, Portland, Oregon, USA. riddlem@ohsu.edu
Thomas Forst
Ronnie Aronson
Leobardo Sauque-Reyna
Elisabeth Souhami
Louise Silvestre
Lin Ping
Julio Rosenstock
Sanofi (France) · FRDallas Diabetes Research Center · USInstitut für Klinische Forschung und Entwicklung · DELMC Diabetes & Endocrinology (Canada) · CAOregon Health & Science University · USSanofi (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWhen oral therapy for type 2 diabetes is ineffective, adding basal insulin improves glycemic control. However, when glycated hemoglobin (HbA1c) remains elevated because of postprandial hyperglycemia, the next therapeutic step is controversial. We examined the efficacy and safety of lixisenatide in patients with HbA1c still elevated after initiation of insulin glargine. RESEARCH DESIGN AND

methodsThis double-blind, parallel-group trial enrolled patients with HbA1c 7-10% despite oral therapy. Insulin glargine was added and systematically titrated during a 12-week run-in, after which candidates with fasting glucose ≤ 7.8 mmol/L and HbA1c 7-9% were randomized to lixisenatide 20 µg or placebo for 24 weeks while insulin titration continued. The primary end point was HbA1c change after randomization.

resultsThe randomized population (n = 446) had mean diabetes duration of 9.2 years, BMI 31.8 kg/m(2), and daily glargine dosage of 44 units. HbA1c had decreased during run-in from 8.6 to 7.6%; adding lixisenatide further reduced HbA1c by 0.71 vs. 0.40% with placebo (least squares mean difference, -0.32%; 95% CI, -0.46 to -0.17; P < 0.0001). More participants attained HbA1c <7% with lixisenatide (56 vs. 39%; P < 0.0001). Lixisenatide reduced plasma glucose 2 h after a standardized breakfast (difference vs. placebo -3.2 mmol/L; P < 0.0001) and had a favorable effect on body weight (difference vs. placebo -0.89 kg; P = 0.0012). Nausea, vomiting, and symptomatic hypoglycemia <3.3 mmol/L were more common with lixisenatide.

conclusionsAdding lixisenatide to insulin glargine improved overall and postprandial hyperglycemia and deserves consideration as an alternative to prandial insulin for patients not reaching HbA1c goals with recently initiated basal insulin.

Indexed as

AgedBlood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodDrug Administration ScheduleFemaleGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemic AgentsInsulin GlargineInsulin, Long-ActingMaleMiddle AgedPeptidesTreatment OutcomeBlood GlucoseGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHypoglycemic AgentsInsulin GlargineInsulin, Long-ActinglixisenatidePeptides

Identifiers

PMID23564915
PMCPMC3747901
OpenAlexW2135064706

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.