Evidence map›Paper›PMID 20067954›Full record

Trial reportDiabetes care2010

Failure to preserve beta-cell function with mycophenolate mofetil and daclizumab combined therapy in patients with new- onset type 1 diabetes.

Peter A Gottlieb, Scott Quinlan, Heidi Krause-Steinrauf, Carla J Greenbaum, Darrell M Wilson, Henry Rodriguez, Desmond A Schatz, Antoinette M Moran, John M Lachin, Jay S Skyler and 1 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2010. 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 81 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 2 pooled it
10.0field-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.

NCT00100178 phase2completednot on this map

New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab Clinical Trial (Preservation of Pancreatic Production of Insulin Through Immunosuppression-POPPII #1)

TypeinterventionalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2004 to 2008Enrolled126ConditionsDiabetes Mellitus, Type 1ArmsMycophenolate mofeteil (MMF), Daclizumab (DZB), Placebo control for Mycophenolate mofeteil (MMF), Placebo control for Daclizumab (DZB)
NCT02131675 completednot on this mapstarted 2012, after this paper: background citation

Observational Study of C-peptide Levels in Youth With Longstanding Type 1 Diabetes Mellitus as Detected by an Ultrasensitive Assay

TypeobservationalSponsorIcahn School of Medicine at Mount SinaiRan2012 to 2013Enrolled50ConditionsType 1 Diabetes MellitusArmsBoost shake
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 2 syntheses or guidelines pooled it, 158 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Screening and Prevention of Type 1 Diabetes: Where Are We?The Journal of clinical endocrinology and metabolism · 2023
    Review
  19. Article
  20. Review

21 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 8 institutions in 1 country.

Peter A GottliebBarbara Davis Center for Childhood Diabetes, University of Colorado at Denver, Aurora, Colorado, USA. peter.gottlieb@ucdenver.edu
Scott Quinlan
Heidi Krause-Steinrauf
Carla J Greenbaum
Darrell M Wilson
Henry Rodriguez
Desmond A Schatz
Antoinette M Moran
John M Lachin
Jay S Skyler
Type 1 Diabetes TrialNet MMF/DZB Study Group
George Washington University · USBenaroya Research InstituteIndiana University – Purdue University Indianapolis · USStanford University · USUniversity of Colorado Denver · USUniversity of Florida · USUniversity of Miami · USUniversity of Minnesota · US

Funding

Northwest Clinical Center for Type 1 Diabetes - TrialNetU01DK061034 · NIDDK · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI GREENBAUM, CARLA J · 2001 to 2018
$10.3M
NIDDK NIH HHS U01 DK061034
6 · The paper itself

Abstract

objectiveThis trial tested whether mycophenolate mofetil (MMF) alone or with daclizumab (DZB) could arrest the loss of insulin-producing beta-cells in subjects with new-onset type 1 diabetes. RESEARCH DESIGN AND

methodsA multi-center, randomized, placebo-controlled, double-masked trial was initiated by Type 1 Diabetes TrialNet at 13 sites in North America and Europe. Subjects diagnosed with type 1 diabetes and with sufficient C-peptide within 3 months of diagnosis were randomized to either MMF alone, MMF plus DZB, or placebo, and then followed for 2 years. The primary outcome was the geometric mean area under the curve (AUC) C-peptide from the 2-h mixed meal tolerance test.

resultsOne hundred and twenty-six subjects were randomized and treated during the trial. The geometric mean C-peptide AUC at 2 years was unaffected by MMF alone or MMF plus DZB versus placebo. Adverse events were more frequent in the active therapy groups relative to the control group, but not significantly.

conclusionsNeither MMF alone nor MMF in combination with DZB had an effect on the loss of C-peptide in subjects with new-onset type 1 diabetes. Higher doses or more targeted immunotherapies may be needed to affect the autoimmune process.

Indexed as

Immunosuppressive AgentsAdolescentAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedChildDaclizumabDiabetes Mellitus, Type 1Drug Therapy, CombinationFemaleHumansImmunoglobulin GInsulin-Secreting CellsMaleMiddle AgedMycophenolic AcidAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDaclizumabImmunoglobulin GImmunosuppressive AgentsMycophenolic Acid

Identifiers

PMID20067954
PMCPMC2845036
OpenAlexW2041941496

What OpenQuestion 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 OpenQuestion graph.