Evidence map›Paper›PMID 35797241›Full record

ArticleDiabetic medicine : a journal of the British Diabetic Association2022

INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA).

Jukka Kero, Jaakko J Koskenniemi, Sara Karsikas, Tytti Pokka, Olivia Lou, Jorma Toppari, Riitta Veijola

3 registry-linked trialsOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetic medicine : a journal of the British Diabetic Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02908087. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 33% 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.

NCT02908087 phase2completed

Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

Ran2016Enrolled13Registered outcomes5Posted comparisons0ConditionsType 1 DiabetesArmsPlacebo, Victoza® (liraglutide)
Open the trial in the graph
NCT02611232 phase2unknown statusnot on this map

Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

TypeinterventionalSponsorUniversity of OuluRan2015 to 2024Enrolled42ConditionsType 1 DiabetesArmsVictoza®, Placebo
NCT02898506 phase2completednot on this map

Incretin-based Therapy in Late Preclinical Type 1 Diabetes

TypeinterventionalSponsorUniversity of OuluRan2016 to 2021Enrolled13ConditionsType 1 DiabetesArmsVictoza®, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Article
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

7 authors at 4 institutions in 3 countries.

Jukka KeroResearch Centre for Integrative Physiology and Pharmacology, Institute of Biomedicine, University of Turku, Turku, Finland.
Jaakko J KoskenniemiResearch Centre for Integrative Physiology and Pharmacology, Institute of Biomedicine, University of Turku, Turku, Finland.
Sara KarsikasDepartment of Paediatrics, Turku University Hospital, Turku, Finland.
Tytti PokkaDepartment for Children and Adolescents, Oulu University Hospital, Oulu, Finland.
Olivia LouJDRF, New York, New York, USA.
Jorma ToppariResearch Centre for Integrative Physiology and Pharmacology, Institute of Biomedicine, University of Turku, Turku, Finland.
Riitta VeijolaDepartment for Children and Adolescents, Oulu University Hospital, Oulu, Finland.ORCID 0000-0002-6557-270X
University of Turku · FIOulu University Hospital · FIBreakthrough T1D · USTurku University Hospital · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsβ-cell stress and dysfunction may contribute to islet autoimmunity and progression to clinical type 1 diabetes. We present a protocol of three randomised controlled trials assessing the effects of glucagon-like peptide 1 (GLP - 1) analogue liraglutide in three early stages of type 1 diabetes.

methodsWe will test 10- to 30-year-old people with multiple islet autoantibodies for their glucose metabolism and randomise participants with stage 1 (multiple islet autoantibodies and normoglycaemia), stage 2 (multiple islet autoantibodies and dysglycaemia) and early stage 3 (clinical diagnosis) type 1 diabetes, 10-14 persons in each, to a 6-month intervention with liraglutide or placebo with 6-month follow-up in the stage 2 and stage 3 trials and 18-month follow-up in the stage 1 trial. Primary efficacy outcome in the stage 1 and stage 2 trials is a first-phase insulin response in an intravenous glucose tolerance test and C-peptide area under the curve in a 2-h mixed-meal tolerance test in the stage 3 trial. In addition, safety and tolerability of liraglutide treatment will be assessed.

conclusionsMost prevention trials of type 1 diabetes have targeted the immune system. Treatment with GLP-1 analogue liraglutide supports the pancreatic β-cells, which should likewise attenuate islet autoimmunity. Our innovative study design allows simultaneous investigation of an intervention in three groups of people who represent various early stages of type 1 diabetes and maximises the eligibility to participate.

trial registrationNCT02611232 (stage 1 trial), NCT02898506 (stage 2 trial), NCT02908087 (stage 3 trial).

Indexed as

Diabetes Mellitus, Type 1IncretinsAdolescentAdultAutoantibodiesChildDouble-Blind MethodGlucagon-Like Peptide-1 ReceptorHumansHypoglycemic AgentsLiraglutideRandomized Controlled Trials as TopicYoung AdultAutoantibodiesGlucagon-Like Peptide-1 ReceptorHypoglycemic AgentsIncretinsLiraglutidediabetes preventionglucagon-like peptide 1 analogueislet autoantibodyliraglutidetype 1 diabetes

Identifiers

PMID35797241
PMCPMC9540026
OpenAlexW4284680501

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.