Evidence map›Paper›PMID 26435365›Full record

Trial reportDiabetic medicine : a journal of the British Diabetic Association2016

Twice-daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin-naïve adults with Type 2 diabetes.

E Franek, M Haluzík, S Canecki Varžić, M Sargin, S Macura, J Zacho, J S Christiansen

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01513590 (A 26-week, Randomised, Open-label, Multinational, Treat-to-target Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart), which is not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT01513590 phase3completednot on this map

A 26-week, Randomised, Open-label, Multinational, Treat-to-target Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart (IDegAsp) Twice Daily (BID) and BIAsp 30 BID Both With Metformin in Insulin naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy or Metformin in Combination With One Additional Oral Antidiabetic Drug (OAD)

TypeinterventionalSponsorNovo Nordisk A/SRan2012 to 2012Enrolled394ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec/insulin aspart
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  2. Pooled it
  3. Pooled it
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  11. Review
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  14. 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
  15. Review
  16. 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

7 authors at 6 institutions in 5 countries.

E FranekMossakowski Medical Research Centre, Polish Academy of Sciences and Department of Internal Diseases, Endocrinology and Diabetology, Central Clinical Hospital MSW, Warsaw, Poland.
M HaluzíkThird Department of Medicine, First Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic.
S Canecki VaržićClinical Hospital Center Osijek, Osijek, Croatia.
M SarginKartal Training and Research Hospital, Istanbul, Turkey.
S MacuraNovo Nordisk A/S, Søborg, Denmark.
J ZachoNovo Nordisk A/S, Søborg, Denmark.
J S ChristiansenAarhus University Hospital, Aarhus, Denmark.
Novo Nordisk (Denmark) · DKAarhus University Hospital · DKDr Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi · TRGeneral University Hospital in Prague · CZKlinički bolnički centar Osijek · HRMossakowski Medical Research Institute, Polish Academy of Sciences · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the efficacy and safety of twice-daily insulin degludec/insulin aspart vs. twice-daily biphasic insulin aspart 30 in people with Type 2 diabetes mellitus who were naïve to insulin.

methodsIn this 26-week, multinational, open-label, controlled, two-arm, parallel-group, treat-to-target trial, participants [mean (± sd) age 58.9 (±8.9) years, duration of diabetes 9.5 (±5.9) years, HbA1c 68 (±8.7) mmol/mol or 8.4 (±0.8)% and BMI 31.2 (±4.2) kg/m(2) ) were randomized (1:1) to insulin degludec/insulin aspart (n = 197) or biphasic insulin aspart 30 (n = 197), administered with breakfast and the main evening meal, titrated to a self-monitored plasma glucose target > 3.9 and ≤ 5.0 mmol/l.

resultsThe mean HbA1c was reduced to 49 mmol/mol (6.6%) with insulin degludec/insulin aspart and 48 mmol/mol (6.5%) with biphasic insulin aspart 30. Insulin degludec/insulin aspart achieved the prespecified non-inferiority margin (estimated treatment difference 0.02%; 95% CI -0.12, 0.17). Insulin degludec/insulin aspart was superior in lowering fasting plasma glucose (estimated treatment difference -1.00 mmol/l; 95% CI -1.4, -0.6; P < 0.001) and reducing overall and nocturnal confirmed hypoglycaemia at a similar overall insulin dose compared with biphasic insulin aspart 30. Similar proportions of participants in each arm experienced severe hypoglycaemia. Adverse events were equally distributed.

conclusionsConsistent with previous findings, insulin degludec/insulin aspart twice daily effectively improved long-term glycaemic control, with superior reductions in FPG, and significantly less overall and nocturnal confirmed hypoglycaemia compared with biphasic insulin aspart 30 in people with Type 2 diabetes who were insulin-naïve.

Indexed as

AgedBiphasic InsulinsBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 2Drug Administration ScheduleDrug CombinationsDrug MonitoringFemaleGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsInsulin AspartInsulin, IsophaneBiphasic InsulinsBlood GlucoseDrug CombinationsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin Aspartinsulin aspart, insulin aspart protamine drug combination 30:70insulin degludec, insulin aspart drug combinationInsulin, IsophaneInsulin, Long-Acting

Identifiers

PMID26435365
PMCPMC5063147
OpenAlexW1871019915

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.