Evidence map›Paper›PMID 26221523›Full record

ArticleJournal of diabetes investigation2015

Efficacy and safety of luseogliflozin added to various oral antidiabetic drugs in Japanese patients with type 2 diabetes mellitus.

Yutaka Seino, Nobuya Inagaki, Masakazu Haneda, Kohei Kaku, Takashi Sasaki, Atsushi Fukatsu, Michito Ubukata, Soichi Sakai, Yoshishige Samukawa

Open access · goldAbstract read
In one paragraph

Article in Journal of diabetes investigation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 8 pooled it
4.7field-weighted citation impact, top 5% 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

32 citing papers in PubMed, 8 syntheses or guidelines pooled it, 54 citations in OpenAlex.

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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

9 authors at 7 institutions in 1 country.

Yutaka SeinoKansai Electric Power Hospital Osaka, Japan.
Nobuya InagakiKyoto University Graduate School of Medicine Kyoto, Japan.
Masakazu HanedaAsahikawa Medical University Hokkaido, Japan.
Kohei KakuKawasaki Medical School, Department of Internal Medicine Okayama, Japan.
Takashi SasakiDivision of Diabetes and Endocrinology, The Jikei University Graduatle School of Medical Research Tokyo, Japan.
Atsushi FukatsuYachiyo Hospital Aichi, Japan.
Michito UbukataTaisho Pharmaceutical Co., Ltd. Tokyo, Japan.
Soichi SakaiTaisho Pharmaceutical Co., Ltd. Tokyo, Japan.
Yoshishige SamukawaTaisho Pharmaceutical Co., Ltd. Tokyo, Japan.
Taisho Pharmaceutical (Japan) · JPAsahikawa Medical University · JPJikei University School of Medicine · JPKansai Electric Power Hospital · JPKawasaki Medical School · JPKyoto University · JPNational Sanyo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTwo studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy. MATERIALS AND

methodsIn the trial involving add-on to sulfonylureas (study 03-1), patients were randomly assigned to receive luseogliflozin 2.5 mg or a placebo for a 24-week double-blind period, followed by a 28-week open-label period. In the open-label trial involving add-on to other OADs; that is, biguanides, dipeptidyl peptidase-4 inhibitors, thiazolidinediones, glinides and α-glucosidase inhibitors (study 03-2), patients received luseogliflozin for 52 weeks.

resultsIn study 03-1, luseogliflozin significantly decreased glycated hemoglobin at the end of the 24-week double-blind period compared with the placebo (-0.88%, P < 0.001), and glycated hemoglobin reduction from baseline at week 52 was -0.63%. In study 03-2, luseogliflozin added to other OADs significantly decreased glycated hemoglobin from baseline at week 52 (-0.52 to -0.68%, P < 0.001 for all OADs). Bodyweight reduction was observed in all add-on therapies, even with agents associated with weight gain, such as sulfonylureas and thiazolidinediones. Most adverse events were mild in severity. When added to a sulfonylurea, incidences of hypoglycemia during the double-blind period were 8.7% and 4.2% for luseogliflozin and placebo, respectively, but no major hypoglycemic episodes occurred. The frequency and incidences of adverse events of special interest for sodium glucose cotransporter 2 inhibitors and adverse events associated with combined OADs were acceptable.

conclusionsAdd-on therapies of luseogliflozin to existing OADs improved glycemic control, reduced bodyweight and were well tolerated in Japanese type 2 diabetic patients. These trials were registered with the Japan Pharmaceutical Information Center (add on to sulfonylurea: JapicCTI-111507; add on to other OADs: JapicCTI-111508).

Indexed as

Add-on therapyLuseogliflozinOral antidiabetic drug

Identifiers

PMID26221523
PMCPMC4511304
OpenAlexW2036498924

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.