Evidence map›Paper›PMID 30474818›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2019

Efficacy and Safety of IDegAsp Versus BIAsp 30, Both Twice Daily, in Elderly Patients with Type 2 Diabetes: Post Hoc Analysis of Two Phase 3 Randomized Controlled BOOST Trials.

Greg Fulcher, Roopa Mehta, Edmond G Fita, Magnus Ekelund, Stephen C Bain

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.

NCT01009580 phase3completednot on this map

A 26-week, Randomised, Open-labelled, Two-arm, Parallel-group, Treat-to-target Trial Comparing Efficacy and Safety of Soluble Insulin Analogue Combination (SIAC) Twice Daily (BID) With Biphasic Insulin Aspart (BIAsp) 30 BID, With or Without Metformin, With or Without DPP-4 Inhibitor, With or Without Pioglitazone in Subjects With Type 2 Diabetes in Inadequate Glycaemic Control on Once or Twice Daily Premixed or Self-mixed Insulin Regimen With or Without OADs (BOOST™: Intensify Premix 1)

TypeinterventionalSponsorNovo Nordisk A/SRan2009 to 2010Enrolled447ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec/insulin aspart, biphasic insulin aspart 30
NCT01059812 phase3completednot on this map

A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™: INTENSIFY ALL)

TypeinterventionalSponsorNovo Nordisk A/SRan2010 to 2010Enrolled424ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec/insulin aspart, biphasic insulin aspart 30
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
  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

5 authors.

Greg FulcherRoyal North Shore Hospital, University of Sydney, Sydney, NSW, Australia. greg.fulcher@sydney.edu.au.
Roopa MehtaUnidad de Investigación en Enfermedades Metabólicas, Departamento de Endocrinología y Metabolismo, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Edmond G FitaNovo Nordisk A/S, Søborg, Denmark.
Magnus EkelundNovo Nordisk A/S, Søborg, Denmark.
Stephen C BainDiabetes Research Unit Cymru, Swansea University, ABM University Health Board, Swansea, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe majority of elderly patients (≥ 65 years of age) with type 2 diabetes mellitus (T2DM) will eventually require insulin therapy, but they are particularly vulnerable to hypoglycemia and challenging to treat. Insulin degludec/insulin aspart (IDegAsp) is a novel co-formulation of 70% insulin degludec and 30% insulin aspart administered in a single injection, either once or twice daily with main meals.

methodsA combined analysis of the phase 3 BOOST INTENSIFY PREMIX I (NCT01009580) and BOOST INTENSIFY ALL (NCT01059812) trials has previously reported lower rates of hypoglycemia during the maintenance period in patients with T2DM treated with IDegAsp twice daily (BID) versus biphasic insulin aspart 30 (BIAsp 30) BID. This post hoc analysis examined the safety and efficacy of IDegAsp versus BIAsp 30 in elderly patients from the global population of these two trials, and also from the Japanese cohort of BOOST INTENSIFY ALL.

resultsChange in HbA

conclusionThe results described here are consistent with those of the overall trial populations, demonstrating that IDegAsp BID is efficacious in elderly patients and suggesting that there is no need for special safety precautions.

fundingNovo Nordisk.

trial registrationClinicalTrials.gov identifiers, NCT01009580 and NCT01059812. Plain language summary available for this article.

Indexed as

ElderlyInsulin degludec/insulin aspartType 2 diabetes

Identifiers

PMID30474818
PMCPMC6349271

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.