Evidence mapPaperPMID 30869183Full record

Trial reportDiabetes, obesity & metabolism2019

Efficacy and safety of insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Chinese adults with type 2 diabetes: A phase III, open-label, 2:1 randomized, treat-to-target trial.

Wenying Yang, Jianhua Ma, Tianpei Hong, Ming Liu, Heng Miao, Yongde Peng, Changjiang Wang, Xiangjin Xu, Tao Yang, Anne M Nielsen and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
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. It is linked to trial NCT02762578 (A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes BOOST), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT02762578 phase3completednot on this map

A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes BOOST: INTENSIFY PREMIX/ALL 2

TypeinterventionalSponsorNovo Nordisk A/SRan2016 to 2017Enrolled543ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec/insulin aspart, biphasic insulin aspart
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 28 citations in OpenAlex.

  1. Trial
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  6. Observational
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  8. Article
  9. Practical guide in using insulin degludec/insulin aspart: A multidisciplinary approach in Malaysia.Malaysian family physician : the official journal of the Academy of Family Physicians of Malaysia · 2023
    Article
  10. Review
  11. Article
  12. Article
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  15. Review
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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

13 authors at 11 institutions in 3 countries.

Wenying YangChina-Japan Friendship Hospital, Beijing, China.ORCID 0000-0002-7997-9404
Jianhua MaNanjing First Hospital, Nanjing, China.
Tianpei HongPeking University Third Hospital, Beijing, China.ORCID 0000-0002-5744-5129
Ming LiuTianjin Medical University General Hospital, Tianjin, China.
Heng MiaoSecond Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yongde PengShanghai First People's Hospital, Shanghai, China.
Changjiang WangFirst Affiliated Hospital of Anhui Medical University, Hefei, China.
Xiangjin XuFuzhou General Hospital of Nanjing Military Command, Fuzhou, China.
Tao YangJiangsu Province Hospital, Jiangsu, China.
Anne M NielsenMedical & Science Degludec Portfolio, Novo Nordisk A/S, Søborg, Denmark.ORCID 0000-0003-0268-5763
Lili PanNovo Nordisk (China) Pharmaceuticals Co. Ltd, Beijing, China.
Weihong LiuNovo Nordisk (China) Pharmaceuticals Co. Ltd, Beijing, China.
Weigang ZhaoPeking Union Medical College Hospital, Beijing, China.
Novo Nordisk (Switzerland) · CHAnhui Medical University · CNChina-Japan Friendship Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFuzhou General Hospital of Nanjing Military Command · CNJiangsu Province Hospital · CNNovo Nordisk (Denmark) · DKPeking University · CNSecond Affiliated Hospital of Nanjing Medical University · CNShanghai First People's Hospital · CNTianjin Medical University General Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess the efficacy and safety of twice-daily insulin degludec/insulin aspart (IDegAsp) versus biphasic insulin aspart 30 (BIAsp 30) twice daily, both ± metformin, in Chinese adults (N = 543) with type 2 diabetes (T2D) inadequately controlled on premixed/self-mixed or basal insulin ± metformin. MATERIALS AND

methodsWe conducted a 26-week, phase III, open-label, treat-to-target, 2:1 randomized trial. Hierarchical testing was used with non-inferiority of glycated haemoglobin (HbA1c) change from baseline to week 26 as the primary endpoint and superiority for the confirmatory secondary endpoints which were as follows: change from baseline in fasting plasma glucose (FPG); nocturnal confirmed hypoglycaemic episodes (12:01-5:59 am, inclusive); total confirmed hypoglycaemic episodes (severe or plasma glucose <3.1 mmol/L with/without symptoms); body weight; and percentage of responders (HbA1c <53 mmol/mol [<7.0%]) without confirmed hypoglycaemic episodes.

resultsNon-inferiority for change from baseline to week 26 in HbA1c and superiority of IDegAsp twice daily versus BIAsp 30 twice daily for change in FPG, nocturnal confirmed and total confirmed hypoglycaemic episodes, was demonstrated. Estimated rates of nocturnal confirmed and total confirmed hypoglycaemic episodes were 47% and 43% lower, respectively, with IDegAsp twice daily versus BIAsp 30 twice daily. Superiority for change in body weight was not confirmed. Participants were more likely to reach the HbA1c goal of <53 mmol/mol (<7.0%) without confirmed hypoglycaemia with IDegAsp twice daily versus BIAsp 30 twice daily by trial end. No new safety signals were identified.

conclusionsThe efficacy and safety of IDegAsp in Chinese patients with T2D was demonstrated, confirming results from international trials.

Indexed as

Biphasic InsulinsHypoglycemic AgentsInsulin AspartInsulin, IsophaneInsulin, Long-ActingAgedBlood GlucoseBody WeightChinaDiabetes Mellitus, Type 2Drug CombinationsFemaleGlycated HemoglobinHumansHypoglycemiaMaleBiphasic InsulinsBlood GlucoseDrug CombinationsGlycated HemoglobinHypoglycemic AgentsInsulin Aspartinsulin aspart, insulin aspart protamine drug combination 30:70insulin degludec, insulin aspart drug combinationInsulin, IsophaneInsulin, Long-Actingbiphasic insulin aspartinsulin aspartinsulin degludecinsulin treatmentintensive insulin therapytype 2 diabetes

Identifiers

PMID30869183
PMCPMC6617768
OpenAlexW2920856255

What Socratic 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 Socratic graph.