Evidence mapPaperPMID 38310883Full record

ArticleDiabetes & metabolism journal2024

Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study.

Jeonghee Han, Woo Je Lee, Kyu Yeon Hur, Jae Hyoung Cho, Byung Wan Lee, Cheol-Young Park

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in Diabetes & metabolism journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.4field-weighted citation impact, top 18% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Review
  3. Observational
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

6 authors at 5 institutions in 1 country.

Jeonghee HanLilly Korea Ltd., Seoul, Korea.
Woo Je LeeDepartment of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Kyu Yeon HurDepartment of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Jae Hyoung ChoDepartment of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Byung Wan LeeDepartment of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Cheol-Young ParkDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Ulsan College · KRKorea Pharma (South Korea) · KRSamsung Medical Center · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRYonsei University · KR

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

backgruoundTo investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM).

methodsThis was a real-world, prospective, non-interventional post-marketing safety study conducted from May 26, 2015 to May 25, 2021 at 85 Korean healthcare centers using electronic case data. Data on patients using dulaglutide 0.75 mg/0.5 mL or the dulaglutide 1.5 mg/0.5 mL single-use pens were collected and pooled. The primary objective was to report the frequency and proportion of adverse and serious adverse events that occurred. The secondary objective was to monitor the effectiveness of dulaglutide at 12 and 24 weeks by evaluating changes in glycosylated hemoglobin (HbA1c ), fasting plasma glucose, and body weight.

resultsData were collected from 3,067 subjects, and 3,022 subjects who received ≥1 dose (of any strength) of dulaglutide were included in the safety analysis set (53% female, mean age 56 years; diabetes duration 11.2 years, mean HbA1c 8.8%). The number of adverse events reported was 819; of these, 68 (8.3%) were serious adverse events. One death was reported. Adverse events were mostly mild in severity; 60.81% of adverse events were considered related to dulaglutide. This study was completed by 72.73% (2,198/3,022) of subjects. At 12/24 weeks there were significant (P<0.0001) reductions from baseline in least-squares mean HbA1c (0.96%/0.95%), fasting blood glucose (26.24/24.43 mg/dL), and body weight (0.75/1.21 kg).

conclusionDulaglutide was generally well tolerated and effective in real-world Korean individuals with T2DM. The results from this study contribute to the body of evidence for dulaglutide use in this population.

Indexed as

Blood GlucoseDiabetes Mellitus, Type 2Glucagon-Like PeptidesGlycated HemoglobinHypoglycemic AgentsImmunoglobulin Fc FragmentsProduct Surveillance, PostmarketingRecombinant Fusion ProteinsAdultAgedBody WeightFemaleHumansMaleMiddle AgedProspective StudiesBlood GlucosedulaglutideGlucagon-Like PeptidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsDiabetes mellitus, type 2DulaglutideProduct surveillance, postmarketingProspective studiesRepublic of Korea

Identifiers

PMID38310883
PMCPMC11140407
OpenAlexW4391519198

What Socratic holds

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LicenceCC BY-NC
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 Socratic graph.