Evidence map›Paper›PMID 31144427›Full record

Trial reportDiabetes, obesity & metabolism2019

A pre-specified statistical analysis plan for the VERIFY study: Vildagliptin efficacy in combination with metformin for early treatment of T2DM.

David R Matthews, Päivi M Paldánius, Michael Stumvoll, Jackie Han, Giovanni Bader, YannTong Chiang, Pieter Proot, Stefano Del Prato

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Adjusting the Use of Glucose-Lowering Agents in the Real-World Clinical Management of People with Type 2 Diabetes: A Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Review
  5. Article
  6. 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

8 authors at 4 institutions in 5 countries.

David R MatthewsOxford Centre for Diabetes Endocrinology and Metabolism, Radcliffe Department of Medicine, Oxford, UK.ORCID 0000-0001-6504-0036
Päivi M PaldániusDepartment of Cardiovascular Metabolism, Novartis Pharma AG, Basel, Switzerland.
Michael StumvollDivisions of Endocrinology and Diabetes, University Hospital Leipzig, Leipzig, Germany.
Jackie HanClinical Development and Analytics, Novartis Pharmaceutical Corporation, East Hanover, New Jersey.
Giovanni BaderDepartment of Cardiovascular Metabolism, Novartis Pharma AG, Basel, Switzerland.
YannTong ChiangClinical Development and Analytics, Novartis Pharmaceutical Corporation, East Hanover, New Jersey.
Pieter ProotDepartment of Cardiovascular Metabolism, Novartis Pharma AG, Basel, Switzerland.
Stefano Del PratoDepartment of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Pisa, Italy.ORCID 0000-0002-5388-0270
Novartis (Switzerland) · CHUniversity Hospital Leipzig · DEUniversity of Oxford · GBUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo ensure the integrity of the planned analyses and maximize the clinical utility of the VERIFY study results by describing the detailed concepts behind its statistical analysis plan (SAP) before completion of data collection and study database lock. The SAP will be adhered to for the final primary data analysis of the VERIFY trial. MATERIALS AND

methodsVildagliptin efficacy in combination with metformin for early treatment of T2DM (VERIFY) is an ongoing, multicentre, randomized controlled trial aiming to demonstrate the clinical benefits of glycaemic durability and glucose control achieved with an early combination therapy in newly-diagnosed type 2 diabetes (T2DM) patients.

resultsThe SAP was initially designed at the study protocol conception phase and later modified, as reported here, in collaboration between the steering committee members, statisticians, and the VERIFY study leadership team. All authors were blinded to treatment allocation. An independent statistician has additionally retrieved and presented unblinded data to the independent data safety monitoring committee. An overview of the trial design with a focus on describing the fine-tuning of the analysis plan for the primary efficacy endpoint, risk of initial treatment failure, and secondary, exploratory and pre-specified subgroup analyses is provided here.

conclusionAccording to optimal trial practice, the details of the statistical analysis and data-handling plan prior to locking the database are reported here. The SAP accords with high-quality standards of internal validity to minimize analysis bias and will enhance the utility of the reported results for improved outcomes in the management of T2DM.

Indexed as

Blood GlucoseData Interpretation, StatisticalDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleHumansHypoglycemic AgentsMaleMetforminMiddle AgedTreatment OutcomeVildagliptinBlood GlucoseHypoglycemic AgentsMetforminVildagliptinglycaemic durabilityrandomized controlled trialstatistical analysis plantype 2 diabetes mellitusVERIFY studyvildagliptin

Identifiers

PMID31144427
PMCPMC6771473
OpenAlexW2947701365

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.