Evidence map›Paper›PMID 32573927›Full record

Trial reportDiabetes, obesity & metabolism2020

Exenatide extended release in patients with type 1 diabetes with and without residual insulin production.

Kevan C Herold, Jesse Reynolds, James Dziura, David Baidal, Jason Gaglia, Stephen E Gitelman, Peter A Gottlieb, Jennifer Marks, Louis H Philipson, Rodica Pop-Busui and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. New and emerging therapies in type 1 diabetes mellitus.The Journal of clinical investigation · 2026
    Review
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  15. Review
  16. The emergence of obesity in type 1 diabetes.International journal of obesity (2005) · 2024
    Review
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  20. Article
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.

Kevan C HeroldDepartments of Immunobiology, Yale University, New Haven, Connecticut.ORCID 0000-0003-1534-6613
Jesse ReynoldsBiostatics, Yale University, New Haven, Connecticut.
James DziuraInternal Medicine (Endocrinology), Yale University, New Haven, Connecticut.
David BaidalDepartment of Medicine (Endocrinology), University of Miami, Miami, Florida.
Jason GagliaJoslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.
Stephen E GitelmanDepartment of Pediatrics (Endocrinology), University of California, San Francisco, California.
Peter A GottliebBarbara Davis Diabetes Center, University of Colorado, Anschutz, Colorado.
Jennifer MarksDepartment of Medicine (Endocrinology), University of Miami, Miami, Florida.
Louis H PhilipsonDepartment of Medicine (Endocrinology), The University of Chicago, Chicago, Illinois.
Rodica Pop-BusuiDepartment of Medicine (Endocrinology), The University of Michigan, Ann Arbor, Michigan.
Ruth S WeinstockDepartment of Medicine (Endocrinology), SUNY Upstate Medical University, Syracuse, New York.

Funding

Clinical and Translational Science InstituteUL1TR001872 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI COLLARD, HAROLD R, JACOBY, VANESSA · 2016 to 2025
$112.1M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
SPECIAL ASSAY COREP30DK036836 · NIDDK · JOSLIN DIABETES CENTER · PI JEAN E. SCHAFFER · 1986 to 2026
$50.5M
Yale Diabetes Research CenterP30DK045735 · NIDDK · YALE UNIVERSITY · PI Richard A Flavell · 1993 to 2026
$44.0M
Yale University Clinical and Translational Science Award ProgramUL1TR000142 · NCATS · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2012 to 2015
$31.8M
Pilot and Feasibility ProgramP30DK020595 · NIDDK · UNIVERSITY OF CHICAGO · PI Matthew J Brady · 2013 to 2026
$20.9M
Phase II Trial of HOKT3gamma 1 (ALA-ALA) in Type 1 DiabetesR01DK057846 · NIDDK · YALE UNIVERSITY · PI Kevan C Herold · 2000 to 2026
$11.1M
NIDDK Diabetic Foot Consortium Clinical Research UnitU01DK119083 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI RODICA BUSUI (POP-BUSUI), Crystal Murray Holmes · 2018 to 2026
$5.5M
Targeting Inflammation with Salsalate as a Novel Therapy for Diabetic NeuropathyR01DK107956 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BUSUI (POP-BUSUI), RODICA, FELDMAN, EVA LUCILLE · 2016 to 2020
$3.0M
as well as the following grants from the National Institute of Health P30DK02059as well as the following grants from the National Institute of Health R01DK057846Juvenile Diabetes Research Foundation 5-ECR-2016-186-A-NNational Institute of Health P30DK036836National Institute of Health P30DK045735NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR000142NCATS NIH HHS UL1 TR001863NCATS NIH HHS UL1 TR001872NIDDK NIH HHS P30 DK020595NIDDK NIH HHS P30 DK036836NIDDK NIH HHS P30 DK045735NIDDK NIH HHS R01 DK057846NIDDK NIH HHS R01 DK107956NIDDK NIH HHS U01 DK119083Support was obtained by JDRF 17-2013-504
6 · The paper itself

Abstract

aimsTo test whether a long-acting GLP-1 receptor agonist would improve glucose control in patients with type 1 diabetes (T1D) and to determine whether the presence of residual beta cell function would affect the response. In addition, we sought to determine whether the drug would affect beta cell function.

methodsWe performed a randomized placebo-controlled trial of exenatide extended release (ER) in participants with T1D with and without detectable levels of C-peptide. Seventy-nine participants were randomized to exenatide ER 2 mcg weekly, or placebo, stratified by the presence or absence of detectable C-peptide levels. The primary outcome was the difference in glycated haemoglobin (HbA1c) levels at 24 weeks. Participants were followed for another 6 months off study drug.

resultsAt week 24, the time of the primary outcome, the least squares (LS) mean HbA1c level was 7.76% (95% confidence interval [CI] 7.42, 8.10) in the exenatide ER group versus 8.0% (95% CI 7.64, 8.35) in the placebo group (P = 0.08). At week 12 the LS mean HbA1c levels were 7.71% (95% CI 7.37, 8.05) in the exenatide ER group versus 8.05% (95% CI 7.7, 8.4) in the placebo group (P = 0.01). The improvement at week 12 was driven mainly by those with detectable levels of C-peptide. Those treated with exenatide ER lost weight at 12 and 24 weeks compared to those treated with placebo (P <0.001 and P = 0.007). The total insulin dose was lower, but not when corrected for body weight, and was not affected by residual insulin production. Adverse events were more frequent with exenatide ER, but hypoglycaemia was not increased.

conclusionTreatment with exenatide ER may have short-term benefits in some individuals with T1D who are overweight or who have detectable levels of C-peptide, but short-term improvements were not sustained.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2ExenatideGlycated HemoglobinHumansHypoglycemic AgentsInsulinVenomsExenatideGlycated HemoglobinHypoglycemic AgentsInsulinVenomsadjunctive therapyC-peptideglucagon-like peptide-1 receptor agonisttype 1 diabetes

Identifiers

PMID32573927
PMCPMC8009602

What OpenQuestion holds

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Registered trials

None linked

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.