Evidence map›Paper›PMID 30014302›Full record

Trial reportEuropean journal of pediatrics2018

A 26-week, randomized trial of insulin detemir versus NPH insulin in children and adolescents with type 2 diabetes (iDEAt2).

Mark D Wheeler, Margarita Barrientos-Perez, Fu-Sung Lo, Bo Liang, Alison Lunsford, Ólöf Thórisdóttir, Nehama Zuckerman-Levin

Registry-linked trialOpen access · hybridFull text readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of pediatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02131272 (A 26-week Open Label, Randomised, 2-armed, Parallel Group, Multi-centre Trial Investigating Efficacy and Safety of Insulin Detemir Versus Insulin Neutral Protamine Hagedorn in Combination With the Maximum Tolerated Dose of Metformin and Diet/Exercise on Glycaemic Control in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on the Maximum Tolerated Dose of Metformin ± Other Oral Antidiabetic Drug), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 32% 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.

NCT02131272 phase3terminatednot on this map

A 26-week Open Label, Randomised, 2-armed, Parallel Group, Multi-centre Trial Investigating Efficacy and Safety of Insulin Detemir Versus Insulin Neutral Protamine Hagedorn in Combination With the Maximum Tolerated Dose of Metformin and Diet/Exercise on Glycaemic Control in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on the Maximum Tolerated Dose of Metformin ± Other Oral Antidiabetic Drug(s) ± Basal Insulin

TypeinterventionalSponsorNovo Nordisk A/SRan2014 to 2016Enrolled42ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsInsulin detemir, Insulin NPH, Diet/exercise
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. A Review of Interventional Trials in Youth-Onset Type 2 Diabetes: Challenges and Opportunities.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021
    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

7 authors at 5 institutions in 4 countries.

Mark D WheelerThe University of Arizona Department of Pediatrics, 1501 N. Campbell Avenue, Room 3301, PO Box 245073, Tucson, AZ, 85724, USA. mwheeler@peds.arizona.edu.ORCID http://orcid.org/0000-0001-5838-9758
Margarita Barrientos-PerezServicio de Endocrinología Pediátrica, Hospital Angeles de Puebla, Av. Kepler 2143, Cons. 715 B, Col. Reserva Territorial Atlixcayotl, Puebla, CP 72190, Puebla, Mexico.
Fu-Sung LoDivision of Pediatric Endocrinology & Genetics, Department of Pediatrics, Chang Gung Memorial Hospital, Chung Gung University College of Medicine, No. 5 Fusing Street, Gueishan, Taoyuan County, 333, Taiwan.
Bo LiangNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Alison LunsfordDepartment of Pediatrics, Texas Tech University Health Sciences Center, 1400 S Coulter Street, Amarillo, TX, 79106, USA.
Ólöf ThórisdóttirNovo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.
Nehama Zuckerman-LevinPediatric Diabetes Clinic, Institute of Endocrinology, Diabetes and Metabolism, Rambam Health Care Campus, 31096, Haifa, Israel.
Novo Nordisk (Denmark) · DKChang Gung University · TWRambam Health Care Campus · ILTexas Tech University · USUniversity of Arizona · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There are limited studies evaluating the safety and efficacy of treatments in young people with type 2 diabetes (T2D). This study compared the efficacy and safety of insulin detemir versus neutral protamine Hagedorn (NPH) insulin, both in combination with metformin and lifestyle intervention, in children and adolescents with T2D. This randomized, open-label, phase 3 trial recruited patients (n = 42) aged 10-17 years diagnosed with T2D already receiving metformin ± other oral antidiabetic drugs ± basal insulin. Patients were randomized (1:1) to receive either insulin detemir or NPH insulin, both with the maximum tolerated dose of metformin, and lifestyle intervention, over 26 weeks. Enrollment terminated prematurely after 17 months due to a very slow recruitment rate (12% of the target met). After 26 weeks, the observed mean HbA

conclusionNo safety issues were revealed with either basal insulin. Due to the low number of patients recruited, no efficacy conclusions could be drawn. ClinicalTrials.gov identifier: NCT02131272. What is known: • There is a growing worldwide epidemic of type 2 diabetes in children and adolescents. • There is a lack of research and limited treatment options currently available in this population. What is new: • No safety issues with insulin detemir or neutral protamine Hagedorn insulin in children and adolescents with type 2 diabetes were observed. • Improving clinical trial recruitment, along with providing early, efficacious, and safe treatment options, in this population is critical.

Indexed as

AdolescentBlood GlucoseChildDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulin DetemirInsulin, IsophaneLife StyleMaleMetforminBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulin DetemirInsulin, IsophaneMetforminAdolescentsChildrenInsulin detemirNPH insulinType 2 diabetes

Identifiers

PMID30014302
PMCPMC6153598
OpenAlexW2884666203

What OpenQuestion holds

Textfull text, public
LicenceCC BY
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.