Evidence map›Paper›PMID 19246588›Full record

Trial reportDiabetes care2009

Effects of prandial versus fasting glycemia on cardiovascular outcomes in type 2 diabetes: the HEART2D trial.

Itamar Raz, Peter W F Wilson, Krzysztof Strojek, Irina Kowalska, Velimir Bozikov, Anselm K Gitt, György Jermendy, Barbara N Campaigne, Lisa Kerr, Zvonko Milicevic and 1 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2009. 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 114 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 11 pooled it
22.5field-weighted citation impact, top 1% 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.

NCT02879409 naactive not recruitingstarted 2016, after this paper: background citation

Does Glycated Hemoglobin Variability in Type 2 Diabetes Differ Depending on the Diabetes Treatment Threshold Used in the Qatari Population: Implication on Diabetes Complication Risk?

Ran2016Enrolled150Registered outcomes4Posted comparisons0ConditionsDiabetes Mellitus Type 2Armsdapagliflozin, Gliclazide, human insulin, liraglutide, Metformin
PMID 9742977PMID 19092145PMID 9886743PMID 9742976PMID 10938048PMID 12020338PMID 14694008PMID 15189396PMID 15921524PMID 16004665PMID 16801566PMID 17490424other papers from this trial
Open the trial in the graph
NCT00191282 phase4completednot on this map

Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes (HEART2D)

TypeinterventionalSponsorEli Lilly and CompanyRan2002 to 2007Enrolled1,116ConditionsDiabetes Mellitus, Type 2, Acute Myocardial InfarctionArmsInsulin lispro, Human insulin isophane suspension (NPH), Insulin glargine, Human insulin isophane suspension, Human insulin 30/70
3 · Its place in the literature

Who cites it

114 citing papers in PubMed, 11 syntheses or guidelines pooled it, 353 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. Pooled it
  9. Guideline
  10. Pooled it
  11. Standards of medical care in diabetes--2010.Diabetes care · 2010 · on this map
    Guideline
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

54 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 5 countries.

Itamar RazInternal Medicine, Hadassah Hospital, Jerusalem, Israel.
Peter W F Wilson
Krzysztof Strojek
Irina Kowalska
Velimir Bozikov
Anselm K Gitt
György Jermendy
Barbara N Campaigne
Lisa Kerr
Zvonko Milicevic
Scott J Jacober
Eli Lilly (United States) · USBajcsy-Zsilinszky Kórház és Rendelőintézet · HUEmory University · USKlinikum Ludwigshafen · DEMedical University of Białystok · PLSilesian Center for Heart Disease · PLUniversity Hospital Dubrava · HR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveHyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus (HEART2D) is a multinational, randomized, controlled trial designed to compare the effects of prandial versus fasting glycemic control on risk for cardiovascular outcomes in patients with type 2 diabetes after acute myocardial infarction (AMI). RESEARCH DESIGN AND

methodsPatients (type 2 diabetes, aged 30-75 years) were randomly assigned within 21 days after AMI to the 1) prandial strategy (PRANDIAL) (three premeal doses of insulin lispro targeting 2-h postprandial blood glucose <7.5 mmol/l) or the 2) basal strategy (BASAL) (NPH twice daily or insulin glargine once daily targeting fasting/premeal blood glucose <6.7 mmol/l).

resultsA total of 1,115 patients were randomly assigned (PRANDIAL n = 557; BASAL n = 558), and the mean patient participation after randomization was 963 days (range 1-1,687 days). The trial was stopped for lack of efficacy. Risks of first combined adjudicated primary cardiovascular events in the PRANDIAL (n = 174, 31.2%) and BASAL (n = 181, 32.4%) groups were similar (hazard ratio 0.98 [95% CI 0.8-1.21]). Mean A1C did not differ between the PRANDIAL and BASAL groups (7.7 +/- 0.1 vs. 7.8 +/- 0.1%; P = 0.4) during the study. The PRANDIAL group showed a lower daily mean postprandial blood glucose (7.8 vs. 8.6 mmol/l; P < 0.01) and 2-h postprandial blood glucose excursion (0.1 vs. 1.3 mmol/l; P < 0.001) versus the BASAL group. The BASAL group showed lower mean fasting blood glucose (7.0 vs. 8.1 mmol/l; P < 0.001) and similar daily fasting/premeal blood glucose (7.7 vs. 7.3 mmol/l; P = 0.233) versus the PRANDIAL group.

conclusionsTreating diabetic survivors of AMI with prandial versus basal strategies achieved differences in fasting blood glucose, less-than-expected differences in postprandial blood glucose, similar levels of A1C, and no difference in risk for future cardiovascular event rates.

Indexed as

FastingPostprandial PeriodAdultAgedBody WeightCardiovascular SystemDiabetes Mellitus, Type 2Drug Administration ScheduleFemaleHumansHypoglycemic AgentsInsulinInsulin GlargineInsulin LisproInsulin, Long-ActingMaleHypoglycemic AgentsInsulinInsulin GlargineInsulin LisproInsulin, Long-Acting

Identifiers

PMID19246588
PMCPMC2646013
OpenAlexW2172111876

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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.