Evidence mapPaperPMID 35581902Full record

Trial reportDiabetes, obesity & metabolism2022

A double-blind, Randomized controlled trial on glucose-lowering EFfects and safety of adding 0.25 or 0.5 mg lobeglitazone in type 2 diabetes patients with INadequate control on metformin and dipeptidyl peptidase-4 inhibitor therapy: REFIND study.

Soree Ryang, Sang Soo Kim, Ji Cheol Bae, Ji Min Han, Su Kyoung Kwon, Young Il Kim, Il Seong Nam-Goong, Eun Sook Kim, Mi-Kyung Kim, Chang Won Lee and 5 more

Open access · hybridAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2022. 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
0.7field-weighted citation impact, top 29% 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, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

15 authors at 8 institutions in 2 countries.

Soree RyangDepartment of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea.ORCID 0000-0002-5251-5554
Sang Soo KimDepartment of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea.ORCID 0000-0002-9687-8357
Ji Cheol BaeDepartment of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.ORCID 0000-0002-4763-5797
Ji Min HanDepartment of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea.ORCID 0000-0002-7881-9732
Su Kyoung KwonDepartment of Internal Medicine, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, South Korea.
Young Il KimDepartment of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.ORCID 0000-0002-2960-1040
Il Seong Nam-GoongDepartment of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.ORCID 0000-0002-0492-0467
Eun Sook KimDepartment of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.ORCID 0000-0002-9311-4642
Mi-Kyung KimDepartment of Internal Medicine, Inje University Haeundae Paik Hospital, College of Medicine, Inje University, Busan, South Korea.ORCID 0000-0003-1111-9122
Chang Won LeeDepartment of Internal Medicine, Busan St. Mary's Hospital, Busan, South Korea.ORCID 0000-0002-6184-7171
Soyeon YooDepartment of Internal Medicine, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, South Korea.
Gwanpyo KohDepartment of Internal Medicine, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, South Korea.ORCID 0000-0002-6020-2777
Min Jeong KwonDivision of Endocrinology & Metabolism, Department of Internal Medicine, Busan Paik Hospital, College of Medicine, Inje University, Busan, South Korea.ORCID 0000-0002-9616-870X
Jeong Hyun ParkDivision of Endocrinology & Metabolism, Department of Internal Medicine, Busan Paik Hospital, College of Medicine, Inje University, Busan, South Korea.ORCID 0000-0002-0045-4438
In Joo KimDepartment of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea.ORCID 0000-0003-1765-0774
Pusan National University Hospital · KRUlsan College · KRInje University Busan Paik Hospital · KRJeju National University Hospital · KRSamsung (South Korea) · KRInje University Haeundae Paik Hospital · KRKosin University Gospel Hospital · KRSt. Mary's Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the efficacy and safety of adding low-dose lobeglitazone (0.25 mg/day) or standard-dose lobeglitazone (0.5 mg/day) to patients with type 2 diabetes mellitus (T2DM) with inadequate glucose control on metformin and dipeptidyl peptidase (DPP4) inhibitor therapy. MATERIALS AND

methodsIn this phase 4, multicentre, double-blind, randomized controlled, non-inferiority trial, patients with T2DM insufficiently controlled by metformin and DPP4 inhibitor combination therapy were randomized to receive either low-dose or standard-dose lobeglitazone. The primary endpoint was non-inferiority of low-dose lobeglitazone in terms of glycaemic control, expressed as the difference in mean glycated haemoglobin levels at week 24 relative to baseline values and compared with standard-dose lobeglitazone, using 0.5% non-inferiority margin.

resultsAt week 24, the mean glycated haemoglobin levels were 6.87 ± 0.54% and 6.68 ± 0.46% in low-dose and standard-dose lobeglitazone groups, respectively (p = .031). The between-group difference was 0.18% (95% confidence interval 0.017-0.345), showing non-inferiority of the low-dose lobeglitazone. Mean body weight changes were significantly greater in the standard-dose group (1.36 ± 2.23 kg) than in the low-dose group (0.50 ± 1.85 kg) at week 24. The changes in HOMA-IR, lipid profile and liver enzyme levels showed no significant difference between the groups. Overall treatment-emergent adverse events (including weight gain, oedema and hypoglycaemia) occurred more frequently in the standard-dose group.

conclusionsAdding low-dose lobeglitazone to metformin and DPP4 inhibitor combination resulted in a non-inferior glucose-lowering outcome and fewer adverse events compared with standard-dose lobeglitazone. Therefore, low-dose lobeglitazone might be one option for individualized strategy in patients with T2DM.

Indexed as

Diabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsMetforminBlood GlucoseDipeptidyl-Peptidases and Tripeptidyl-PeptidasesDouble-Blind MethodDrug Therapy, CombinationGlucoseGlycated HemoglobinHumansHypoglycemic AgentsProtease InhibitorsPyrimidinesThiazolidinedionesTreatment OutcomeBlood GlucoseDipeptidyl-Peptidase IV InhibitorsDipeptidyl-Peptidases and Tripeptidyl-PeptidasesGlucoseGlycated HemoglobinHypoglycemic AgentslobeglitazoneMetforminProtease InhibitorsPyrimidinesThiazolidinedionesantidiabetic drugsbeta-cell functionglycaemic controlthiazolidinedionestype 2 diabetes

Identifiers

PMID35581902
PMCPMC9541308
OpenAlexW4280543415

What Socratic holds

Texttitle and abstract
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 Socratic graph.