Evidence map›Paper›PMID 26767080›Full record

ArticleJournal of clinical medicine research2016

Efficacy and Safety of Ipragliflozin in Japanese Patients With Type 2 Diabetes: Interim Outcome of the ASSIGN-K Study.

Takashi Iizuka, Kotaro Iemitsu, Masahiro Takihata, Masahiko Takai, Shigeru Nakajima, Nobuaki Minami, Shinichi Umezawa, Akira Kanamori, Hiroshi Takeda, Takehiro Kawata and 24 more

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In one paragraph

Article in Journal of clinical medicine research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
–field-weighted citation impact
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

22 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

34 authors.

Takashi IizukaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Kotaro IemitsuStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Masahiro TakihataStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Masahiko TakaiStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Shigeru NakajimaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Nobuaki MinamiStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Shinichi UmezawaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Akira KanamoriStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Hiroshi TakedaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Takehiro KawataStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Shogo ItoStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Taisuke KikuchiStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Hikaru AmemiyaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Mizuki KaneshiroStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Atsuko MokuboStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Tetsuo TakumaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Hideo MachimuraStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Keiji TanakaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Taro AsakuraStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Akira KubotaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Sachio AoyagiStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Kazuhiko HoshinoStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Masashi IshikawaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Yoko MatsuzawaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Mitsuo ObanaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Nobuo SasaiStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Hideaki KaneshigeStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Fuyuki MinagawaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Tatsuya SaitoStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Kazuaki ShinodaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Masaaki MiyakawaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.
Yasushi TanakaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan; Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kanagawa, Japan.
Yasuo TerauchiDepartment of Endocrinology and Diabetes, Yokohama City University Medical Center, Kanagawa, Japan.
Ikuro MatsubaStudy Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIpragliflozin is a sodium-glucose co-transporter 2 inhibitor that can improve glycemic control and reduce body weight and blood pressure in patients with type 2 diabetes mellitus (T2DM). We evaluated the efficacy and safety of ipragliflozin in the real-world clinical setting, with a focus on the changes of body composition up to 3 months of treatment.

methodsThis was a prospective multicenter interventional trial. We investigated changes of the blood pressure, body composition, blood glucose, hemoglobin A1c (HbA1c), ketone bodies, lipids, and insulin after treatment with ipragliflozin (50 - 100 mg/day) for 12 weeks in Japanese patients with T2DM who showed poor glycemic control despite receiving diet and exercise therapy with or without oral antidiabetic drugs for more than 12 weeks.

resultsTwo hundred and fifty-seven subjects were included in the efficacy analysis up to 12 weeks of treatment and 301 subjects were included in the safety analysis. From baseline to 12 weeks, HbA1c showed a change of -0.68% (95% confidence interval (CI): -0.83, -0.53) and fasting blood glucose showed a change of -23.9 mg/dL (95% CI: -30.5, -17.2), with both parameters displaying a significant reduction (P < 0.001). The difference of body weight from baseline was -1.82 kg (95% CI: -2.14, -1.50), and it also showed significant reduction (P < 0.001). Analysis of body composition revealed that body fat changed by -1.46 kg (95% CI: -1.79, -1.14, P < 0.001) and body water changed by -0.37 kg (95% CI: -0.60, -0.14, P < 0.01). Laboratory tests demonstrated improvement of liver function and the lipid profile. Adverse events (AEs) occurred in 22.6% of the subjects, with frequent events being vulvovaginal candidiasis in 2.7% and cystitis in 2.0%. Serious AEs occurred in three subjects.

conclusionsIn patients with T2DM, ipragliflozin improved glycemic control after 1 month of treatment and caused weight loss by reducing body fat more than body water.

Indexed as

Antidiabetic agentBody compositionIpragliflozinSodium-glucose co-transporter 2 inhibitorType 2 diabetes mellitus

Identifiers

PMID26767080
PMCPMC4701067

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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.