Evidence map›Paper›PMID 22985213›Full record

ReviewDiabetes, obesity & metabolism2013

Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study.

M Nauck, A Frid, K Hermansen, A B Thomsen, M During, N Shah, T Tankova, I Mitha, D R Matthews

2 registry-linked trialsAbstract readComparative StudyReview
PubMed Publisher
In one paragraph

Review in Diabetes, obesity & metabolism, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00318461. Cited by 72 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 10 pooled it
9.1field-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.

NCT00318461 phase3completed

Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes

Ran2006Enrolled1,091Registered outcomes14Posted comparisons74ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsGlimepiride, liraglutide, Metformin, Placebo
PMID 21883806PMID 19491535PMID 23010561PMID 22055210PMID 21883438PMID 18931095PMID 22193143PMID 19491536PMID 25504028PMID 23186975PMID 21450987PMID 19245711other papers from this trial
Open the trial in the graph
NCT04272359 unknown statusnot on this mapstarted 2019, after this paper: background citation

Prospective, Parallel Goups Study, Aimed to Evaluating Possible Benefits of the Treatment of New Generation Hypoglycaemic Drugs Compared to Sulphonylureas for the Tratment of Type 2 Diabetes Mellitus

Typeobservational_patient_registrySponsorUniversity of MilanRan2019 to 2021Enrolled138ConditionsT2DM (Type 2 Diabetes Mellitus), Diet, Healthy, Renal Function Disorder, AlbuminuriaArmsSulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 10 syntheses or guidelines pooled it, 140 citations in OpenAlex.

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12 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

9 authors at 6 institutions in 5 countries.

M NauckDiabeteszentrum Bad Lauterberg, Bad Lauterberg im Harz, Bad Lauterberg, Germany. nauck@diabeteszentrum.de
A Frid
K Hermansen
A B Thomsen
M During
N Shah
T Tankova
I Mitha
D R Matthews
Novo Nordisk (Denmark) · DKAarhus University Hospital · DKDiabeteszentrum Bad Lauterberg · DEMedical University of Sofia · BGOxford Centre for Diabetes, Endocrinology and Metabolism · GBSkåne University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo investigate efficacy and safety of dual therapy with liraglutide and metformin in comparison to glimepiride and metformin, and metformin monotherapy over 2 years in patients with type 2 diabetes.

methodsIn the 26-week the Liraglutide Effect and Action in Diabetes (LEAD)-2 core trial, patients (n = 1091) were randomized (2 : 2 : 2 : 1: 2) to liraglutide (0.6, 1.2 or 1.8 mg once-daily), placebo or glimepiride; all with metformin. Patients were enrolled if they were 18-80 years old with HbA1c 7.0-11.0% (previous monotherapy ≥3 months), or 7.0-10.0% (previous combination therapy ≥3 months), and body mass index ≤40 kg/m(2) . Patients completing the 26-week double-blinded phase could enter an 18-month open-label extension.

resultsHbA1c decreased significantly with liraglutide (0.4% with 0.6 mg, 0.6% with 1.2 and 1.8 mg) versus 0.3% increase with metformin monotherapy (p < 0.0001). HbA1c decrease with liraglutide was non-inferior versus 0.5% decrease with glimepiride. Liraglutide groups experienced significant weight loss (2.1, 3.0 and 2.9 kg with 0.6, 1.2 and 1.8 mg, respectively) compared to weight gain (0.7 kg) with glimepiride (p < 0.0001). Weight loss with liraglutide 1.2 and 1.8 mg was significantly greater than with metformin monotherapy (1.8 kg; p = 0.0185 and p = 0.0378 for 1.2 and 1.8 mg, respectively). The occurrence of minor hypoglycaemia was <5.0% in all liraglutide groups, significantly less than with glimepiride (24.0%; p < 0.0001). Liraglutide was well tolerated overall: gastrointestinal events were more common than with glimepiride or metformin monotherapy, but occurrence decreased with time.

conclusionsLiraglutide provided sustained glycaemic control over 2 years comparable to that provided by glimepiride. Liraglutide was well tolerated, and was associated with weight loss and a low rate of hypoglycaemia.

Indexed as

AdolescentAdultAgedAged, 80 and overBlood GlucoseBody Mass IndexDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlucagon-Like Peptide 1Glycated HemoglobinHumansHypoglycemic AgentsLiraglutideMaleBlood GlucoseglimepirideGlucagon-Like Peptide 1Glycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsLiraglutideMetforminSulfonylurea Compounds

Identifiers

PMID22985213
OpenAlexW1998281835

What Socratic holds

Texttitle and abstract
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.