Evidence map›Paper›PMID 32314464›Full record

Trial reportDiabetes, obesity & metabolism2020

Comparison of tofogliflozin versus glimepiride as the third oral agent added to metformin plus a dipeptidyl peptidase-4 inhibitor in Japanese patients with type 2 diabetes: A randomized, 24-week, open-label, controlled trial (STOP-OB).

Toru Kitazawa, Hiroaki Seino, Hiroshi Ohashi, Takeshi Inazawa, Masahiro Inoue, Masumi Ai, Midori Fujishiro, Hisamoto Kuroda, Masayo Yamada, Motonobu Anai and 1 more

Open access · hybridAbstract readMulticenter StudyRandomized 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 16 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 7 pooled it
1.6field-weighted citation impact, top 16% 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

16 citing papers in PubMed, 7 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Impact of tofogliflozin on hepatic outcomes: a systematic review.European journal of clinical pharmacology · 2023
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Review
  13. The Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Body Composition in Type 2 Diabetes Mellitus: A Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Review
  14. Review
  15. Article
  16. 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

11 authors at 10 institutions in 1 country.

Toru KitazawaDivision of Diabetes, Endocrinology and Metabolism, Department of Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Hiroaki SeinoSeino Internal Medicine Clinic, Koriyama, Japan.
Hiroshi OhashiInternal Medicine, Oyama East Clinic, Oyama, Japan.
Takeshi InazawaDepartment of Endocrinology and Metabolism, Kashiwa City Hospital, Kashiwa, Japan.
Masahiro InoueSasazuka Inoue Clinic, Tokyo, Japan.
Masumi AiTanaka Clinic, Wako, Japan.
Midori FujishiroDivision of Diabetes and Metabolism, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.
Hisamoto KurodaGreen Clinic, Mibu, Japan.
Masayo YamadaDivision of Metabolism and Endocrinology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Yokohama, Japan.
Motonobu AnaiResearch Center for Advanced Science and Technology, The University of Tokyo, Tokyo, Japan.
Hisamitsu IshiharaDivision of Diabetes and Metabolism, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.ORCID 0000-0001-8922-6660
Nihon University · JPInoue Hospital · JPKashiwa Municipal Hospital · JPKoriyama Institute of Health Sciences · JPMiwa Internal Medicine Clinic · JPNational Institute of Technology, Oyama College · JPThe Institute of Medical Science, Asahi Life Foundation · JPTokyo Medical and Dental University · JPTokyo Metropolitan Komagome Hospital · JPYokohama Sakae Kyosai Hospital · JP

Funding

Financial support for this trial was provided by Kowa Co. Ltd. Tokyo, Japan. The funder had no role in the trial design, data collection and analysis, or preparation of the manuscript.
6 · The paper itself

Abstract

Metformin plus a dipeptidyl peptidase-4 inhibitor (DPP-4i) is the most common therapy for Japanese patients with type 2 diabetes. This 24-week, multicentre, open-label, parallel-group trial randomized patients on dual therapy to add-on tofogliflozin (20 mg/day, n = 33) or glimepiride (0.5 mg/day, n = 31). The primary outcome was change in body fat percentage. The secondary outcomes included changes in HbA1c, fat mass, fat-free mass, liver function variables and uric acid. Tofogliflozin and glimepiride reduced HbA1c to a similar extent. Body fat percentage did not change from baseline in either group. Fat mass was reduced by tofogliflozin but was increased by glimepiride (by -2.0 ± 1.7 kg and +1.6 ± 1.6 kg, P = .002). Fat-free mass was also reduced by tofogliflozin and increased by glimepiride (by -1.3 ± 1.3 kg and +0.9 ± 2.0 kg, P < .001). Alanine aminotransferase and uric acid levels were reduced by tofogliflozin (P = .006 and P < .001, respectively). These data provide novel information useful for selecting the third oral agent for patients whose diabetes is inadequately controlled with metformin plus DPP-4i dual therapy.

Indexed as

Diabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsMetforminAdministration, OralBenzhydryl CompoundsDipeptidyl-Peptidases and Tripeptidyl-PeptidasesDrug Therapy, CombinationGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsJapanSulfonylurea CompoundsTreatment Outcome6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triolBenzhydryl CompoundsDipeptidyl-Peptidase IV InhibitorsDipeptidyl-Peptidases and Tripeptidyl-PeptidasesglimepirideGlucosidesGlycated HemoglobinHypoglycemic AgentsMetforminSulfonylurea Compoundsbody composition, clinical trial, DPP-4 inhibitor, SGLT2 inhibitor, sulphonylureas, type 2 diabetes

Identifiers

PMID32314464
PMCPMC7496555
OpenAlexW3016750499

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.