Evidence mapPaperPMID 19504715Full record

Trial reportInternational journal of clinical practice2009

Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix 30) can improve glycaemic control in patients treated with basal insulins: a subgroup analysis of the IMPROVE observational study.

J Gumprecht, M Benroubi, V Borzi, R Kawamori, J Shaban, S Shah, M Shestakova, Y Wenying, R Ligthelm, P Valensi and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in International journal of clinical practice, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00659282 (Observational Study of Safety and Effectiveness of NovoMix® 30), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 7% 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.

NCT00659282 completednot on this map

Observational Study of Safety and Effectiveness of NovoMix® 30 (Biphasic Insulin Aspart) for the Treatment of Diabetes Mellitus

TypeobservationalSponsorNovo Nordisk A/SRan2006 to 2008Enrolled57,610ConditionsDiabetes, Diabetes Mellitus, Type 2Armsbiphasic insulin aspart
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Safety and Effectiveness of Switching from a Basal-only to Biphasic Insulin Aspart 30 Insulin Regimen.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2013
    Article
  10. 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

11 authors at 8 institutions in 8 countries.

J GumprechtDepartment of Internal Diseases, Diabetology and Nephrology, Medical University of Silesia, Zabrze, Poland.
M Benroubi
V Borzi
R Kawamori
J Shaban
S Shah
M Shestakova
Y Wenying
R Ligthelm
P Valensi
IMPROVE Study Group Expert Panel
Medical University of Silesia · PLAssistance Publique – Hôpitaux de Paris · FRAzienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele · ITBhatia Hospital · INChina-Japan Friendship Hospital · CNJuntendo University · JPPolyclinic General Hospital · GRWindsor Regional Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe international IMPROVE observational study investigated the safety profile and effectiveness of biphasic insulin aspart 30/70 (BIAsp 30) in the routine treatment of patients with type 2 diabetes. We present analyses for the subgroup of patients who switched from basal insulin to BIAsp 30.

methodsPatients in routine care who started insulin therapy with or switched to BIAsp 30 from existing insulin regimens were eligible for this 26-week study. This analysis includes only patients previously treated with basal insulin. Outcomes including adverse events, hypoglycaemic events and glycaemic profile were recorded from patients' notes, recall and diaries.

resultsOf the 748 patients included (age 59.7+/-11.8 years, diabetes duration 11.4+/-7.3 years, baseline HbA1c 9.1+/-1.6%), 497 were previously using human neutral protamine Hagedorn (NPH) insulin and 245 analogue basal insulin. Overall, major and minor hypoglycaemia rates decreased from baseline to final visit (major: 0.171 to 0.011; minor: 9.70 to 5.89 events/patient-year) and were similar between the subgroups. HbA1c and fasting blood glucose were significantly reduced from baseline (NPH prestudy: -1.6%, -2.4 mmol/l; analogue basal prestudy: -1.8%, -2.4 mmol/l), as was postprandial blood glucose, with 33.8% of patients achieving the HbA1c target < 7% without hypoglycaemia. Insulin dose increased slightly from prestudy (0.33+/-0.21 U/kg), baseline (0.40+/-0.20 U/kg) to final visit (0.52+/-0.26 U/kg); most patients (76%) followed a twice-daily regimen at final visit. Body weight did not change significantly and treatment satisfaction increased.

conclusionsPatients with type 2 diabetes inadequately controlled on basal insulins may improve their glycaemic control by intensification to BIAsp 30 therapy.

Indexed as

Biphasic InsulinsBlood GlucoseDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulinInsulin AspartInsulin, IsophaneMaleMiddle AgedPatient SatisfactionTreatment OutcomeBiphasic InsulinsBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinInsulin Aspartinsulin aspart, insulin aspart protamine drug combination 30:70Insulin, Isophane

Identifiers

PMID19504715
PMCPMC2734926
OpenAlexW1978357328

What Socratic holds

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LicenceCC BY
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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.