Evidence mapPaperPMID 19491535Full record

Trial reportPostgraduate medicine2009

Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits.

Michael Nauck, Michel Marre

2 registry-linked trialsAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Postgraduate medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00318422. Cited by 13 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 5 pooled it
3.5field-weighted citation impact, top 7% 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.

NCT00318422 phase3completed

Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.

Ran2006Enrolled1,041Registered outcomes5Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsGlimepiride, liraglutide, Rosiglitazone
Open the trial in the graph
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
Open the trial in the graph
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 5 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  3. Pooled it
  4. Glucagon-like peptide analogues for type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2011 · on this map
    Pooled it
  5. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2010 · on this map
    Pooled it
  6. Review
  7. Review
  8. Review
  9. Glucagon-like peptide-1 receptor agonists: a systematic review of comparative effectiveness research.Diabetes, metabolic syndrome and obesity : targets and therapy · 2017
    Review
  10. Incretin hormones and the satiation signal.International journal of obesity (2005) · 2013
    Review
  11. Review
  12. Review
  13. The evolving place of incretin-based therapies in type 2 diabetes.Pediatric nephrology (Berlin, Germany) · 2010
    Review
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

2 authors at 2 institutions in 2 countries.

Michael NauckDiabeteszentrum, Kirchberg 21, Bad Lauterberg im Harz, Germany. nauck@diabeteszentrum.de
Michel Marre
Diabeteszentrum Bad Lauterberg · DEUniversité Claude Bernard Lyon 1 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo examine the options for add-on therapy in patients with type 2 diabetes whose disease is no longer adequately controlled by lifestyle interventions and oral antidiabetic drug (OAD)monotherapy.

methodsThis analysis included a subset of patients receiving prior OAD monotherapy from 2 phase 3, 26-week, randomized, double-blind, double-dummy, active-control, parallel-group, multicenter, multinational trials. Prior to randomization, patients not already receiving either metformin or glimepiride were switched to monotherapy with one of these drugs, and the dose was titrated to defined targets. Patients were then randomized to liraglutide (1.8 mg, 1.2 mg, or 0.6 mg once daily), placebo (OAD monotherapy plus placebo), or active comparator (rosiglitazone or glimepiride). For this analysis, only the liraglutide 1.8-mg dose was included. The primary outcome measure was change in glycosylated hemoglobin (HbA1c) from baseline. Secondary endpoints included in this analysis are percentage of patients achieving HbA1c < 7%, change in fasting plasma glucose, systolic blood pressure, body weight, beta-cell function, hypoglycemic episodes, and nausea.

resultsThere was a significant reduction in HbA1c in patients previously treated with OAD monotherapy (P < 0.0001) and significantly more patients achieved HbA1c < 7% (P = 0.0005) with the addition of liraglutide than with rosiglitazone. In addition, rosiglitazone plus glimepiride was associated with significantly more weight gain (P < 0.0001) than liraglutide plus glimepiride (P = 0.04). For patients on metformin monotherapy, the addition of liraglutide or glimepiride resulted in similar levels of glycemic control; however, patients receiving glimepiride had significantly greater weight gain (P < 0.0001) and higher rates of minor hyperglycemia.

conclusionGiven the combination of effective glycemic control and weight benefits, liraglutide is a good option for early add-on therapy for patients on OAD monotherapy.

Indexed as

Body WeightAdministration, OralBlood GlucoseDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesGlucagon-Like Peptide 1Glycated HemoglobinHumansHypoglycemic AgentsLiraglutideMaleMiddle AgedBlood GlucoseGlucagon-Like Peptide 1Glycated HemoglobinHypoglycemic AgentsLiraglutide

Identifiers

PMID19491535
OpenAlexW2073547913

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.