Evidence map›Paper›PMID 26179619›Full record

Trial reportDiabetes, obesity & metabolism2015

Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial.

A Ahmann, H W Rodbard, J Rosenstock, J T Lahtela, L de Loredo, K Tornøe, A Boopalan, M A Nauck, NN2211-3917 Study Group

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01617434. Cited by 55 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 14 pooled it
9.6field-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.

NCT01617434 phase3completed

The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

Ran2012Enrolled451Registered outcomes9Posted comparisons6ConditionsDiabetes, Diabetes Mellitus, Type 2Armsliraglutide, Placebo
PMID 26582052other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 14 syntheses or guidelines pooled it, 100 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

9 authors at 7 institutions in 6 countries.

A AhmannOregon Health and Science University, Portland, OR, USA.
H W RodbardEndocrine and Metabolic Consultants, Rockville, MD, USA.
J RosenstockDallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA.
J T LahtelaUniversity Hospital, Tampere University, Tampere, Finland.
L de LoredoServicio Diabetología y Nutrición, Hospital Privado de Córdoba S.A., Córdoba, Argentina.
K TornøeMedical and Science, GLP-1 and Obesity, Novo Nordisk A/S, Søborg, Denmark.
A BoopalanNovo Nordisk Service Centre, India Pvt Ltd, Bangalore, India.
M A NauckDivision of Diabetology, Medical Department I, St. Josef-Hospital (Ruhr-Universität Bochum), Bochum, Germany.
NN2211-3917 Study Group
Dallas Diabetes Research Center · USHospital Privado · ARNovo Nordisk (Denmark) · DKNovo Nordisk (India) · INOregon Health & Science University · USSt. Josef-Hospital · DETampere University Hospital · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo confirm the superiority, compared with placebo, of adding liraglutide to pre-existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0-10.0% (53-86 mmol/mol)].

methodsIn this 26-week, double-blind, parallel-group study, conducted in clinics or hospitals, 451 subjects were randomized 1 : 1 to once-daily liraglutide 1.8 mg (dose escalated from 0.6 and 1.2 mg/day, respectively, for 1 week each; n = 226) or placebo (n = 225) added to their pre-existing basal insulin analogue (≥20 U/day) ± metformin (≥1500 mg/day). After randomization, insulin adjustments above the pre-study dose were not allowed. The primary endpoint was HbA1c change.

resultsAfter 26 weeks, HbA1c decreased more with liraglutide [-1.3% (-14.2 mmol/mol)] than with placebo [-0.1% (-1.2 mmol/mol); p < 0.0001]. More subjects on liraglutide reached HbA1c targets: <7.0% (59% vs 14%; p < 0.0001) and ≤6.5% (43% vs 4%; p < 0.0001) using slightly less insulin (35.8 IU vs 40.1 IU). Greater decreases from baseline (estimated treatment differences vs placebo; p < 0.0001) occurred in fasting plasma glucose (-1.3 mmol/l), seven-point glucose profiles (-1.6 mmol/l), body weight (-3.1 kg) and systolic blood pressure (-5.0 mmHg). Transient gastrointestinal adverse events (nausea: 22.2% vs 3.1%) and minor hypoglycaemia (18.2% vs 12.4%) were more frequent with liraglutide than placebo, and pulse increased (4.5 beats/min) compared with placebo. No severe hypoglycaemia or pancreatitis occurred.

conclusionsAdding liraglutide to a basal insulin analogue ± metformin significantly improved glycaemic control, body weight and systolic blood pressure compared with placebo. Typical gastrointestinal symptoms and minor hypoglycaemia were more frequent with liraglutide.

Indexed as

AgedBlood GlucoseBlood PressureBody WeightDiabetes Mellitus, Type 2Double-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFastingFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulinsLiraglutideBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinsLiraglutideMetforminGLP-1 analogueglycaemic controlincretin therapyinsulin therapyrandomised trialweight loss therapy

Identifiers

PMID26179619
PMCPMC5054929
OpenAlexW1826263849

What Socratic holds

Texttitle and abstract
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.