Evidence map›Paper›PMID 32488923›Full record

Trial reportDiabetes, obesity & metabolism2020

Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26-week PRONTO-T1D study.

Leslie Klaff, Dachuang Cao, Mary Anne Dellva, Janet Tobian, Junnosuke Miura, Dominik Dahl, Jean Lucas, Juliana Bue-Valleskey

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 44 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 2 pooled it
8.8field-weighted citation impact, top 2% 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.

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

44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. Guideline
  2. 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
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Review
  13. Observational
  14. Article
  15. Article
  16. Article
  17. Review
  18. Observational
  19. Article
  20. Advances in Nanomedicine for Precision Insulin Delivery.Pharmaceuticals (Basel, Switzerland) · 2024
    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

8 authors at 5 institutions in 3 countries.

Leslie KlaffRainier CRC, Renton, Washington, USA.
Dachuang CaoEli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
Mary Anne DellvaEli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
Janet TobianEli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
Junnosuke MiuraTokyo Women's Medical University School of Medicine, Tokyo, Japan.
Dominik DahlGemeinschaftspraxis fur Innere Medizin und Diabetologie, Hamburg, Germany.
Jean LucasLucas Research, Morehead City, North Carolina, USA.
Juliana Bue-ValleskeyEli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.ORCID 0000-0002-9746-7744
Eli Lilly (United States) · USCarteret Community College · USPraxis für Humangenetik · DERainier Clinical Research Center · USTokyo Women's Medical University · JP

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

aimsTo evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26-week, treat-to-target, phase 3 trial. MATERIALS AND

methodsAfter an 8-week lead-in to optimize basal insulin glargine or degludec, patients were randomized to double-blind mealtime URLi (n = 451) or lispro (n = 442), or open-label post-meal URLi (n = 329). The primary endpoint was change from baseline glycated haemoglobin (HbA1c) to 26 weeks (non-inferiority margin 0.4%), with multiplicity-adjusted objectives for postprandial glucose (PPG) excursions after a meal test.

resultsBoth mealtime and post-meal URLi demonstrated non-inferiority to lispro for HbA1c: estimated treatment difference (ETD) for mealtime URLi -0.08% [95% confidence interval (CI) -0.16, 0.00] and for post-meal URLi +0.13% (95% CI 0.04, 0.22), with a significantly higher endpoint HbA1c for post-meal URLi versus lispro (P = 0.003). Mealtime URLi was superior to lispro in reducing 1- and 2-hour PPG excursions during the meal test: ETD -1.55 mmol/L (95% CI -1.96, -1.14) at 1 hour and - 1.73 mmol/L (95% CI -2.28, -1.18) at 2 hours (both P < 0.001). The rate and incidence of severe, documented and postprandial hypoglycaemia (<3.0 mmol/L) was similar between treatments, but mealtime URLi demonstrated a 37% lower rate in the period >4 hours after meals (P = 0.013). Injection site reactions were reported by 2.9% of patients on mealtime URLi, 2.4% on post-meal URLi, and 0.2% on lispro. Overall, the incidence of treatment-emergent adverse events was similar between treatments.

conclusionsThe results showed that URLi provided good glycaemic control, with non-inferiority to lispro confirmed for both mealtime and post-meal URLi, while superior PPG control was demonstrated with mealtime dosing.

Indexed as

Diabetes Mellitus, Type 1AdultBlood GlucoseGlycated HemoglobinHumansHypoglycemic AgentsInsulin GlargineInsulin LisproPostprandial PeriodBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulin GlargineInsulin Lispro

Identifiers

PMID32488923
PMCPMC7539952
OpenAlexW3031122959

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.