Evidence map›Paper›PMID 25411597›Full record

ArticleJournal of diabetes investigation2014

Randomized, placebo-controlled, double-blind glycemic control trial of novel sodium-dependent glucose cotransporter 2 inhibitor ipragliflozin in Japanese patients with type 2 diabetes mellitus.

Atsunori Kashiwagi, Kenichi Kazuta, Satoshi Yoshida, Itsuro Nagase

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of diabetes investigation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00621868 (ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus), which is not on this map. Cited by 59 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 7 pooled it
–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.

NCT00621868 phase2completednot on this map

ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus

TypeinterventionalSponsorAstellas Pharma IncRan2008 to 2009Enrolled361ConditionsDiabetes MellitusArmsipragliflozin, Placebo
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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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

4 authors.

Atsunori KashiwagiShiga University of Medical Science Otsu Shiga Japan.
Kenichi KazutaAstellas Pharma Inc. Chuo-ku Tokyo Japan.
Satoshi YoshidaAstellas Pharma Inc. Chuo-ku Tokyo Japan.
Itsuro NagaseAstellas Pharma Inc. Chuo-ku Tokyo Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

AIMS/

introductionIn the present dose-response study, we evaluated the efficacy and safety of ipragliflozin (ASP1941), a novel and selective inhibitor of sodium-dependent glucose cotransporter 2, in Japanese patients with type 2 diabetes mellitus. MATERIALS AND

methodsA total of 361 patients from 39 Japanese centers were randomized to receive either once-daily oral ipragliflozin (12.5, 25, 50 or 100 mg) or a placebo for 12 weeks.

resultsAll ipragliflozin-treated groups had clinically significant, dose-dependent decreases in glycated hemoglobin (HbA1c) and fasting plasma glucose levels compared with placebo-treated groups. The adjusted mean difference in HbA1c change from baseline to the end of treatment between the placebo and 12.5, 25, 50, and 100 mg ipragliflozin groups were -0.61%, -0.97%, -1.29%, and -1.31%, respectively (P < 0.001). Reductions in HbA1c levels were similar between obese and non-obese patients, and were larger in patients with baseline HbA1c ≥8.4% than in those with HbA1c <8.4%. Furthermore, bodyweight significantly (P < 0.001) and dose-dependently decreased among ipragliflozin-treated groups compared with the placebo group. The incidence of adverse events was similar across all groups. However, mild increases in hematocrit and blood urea nitrogen were found in ipragliflozin treated groups.

conclusionsOnce-daily administration of ipragliflozin was dose-dependently effective in glycemic control without major adverse effects. Ipragliflozin was equally effective between obese and non-obese patients, and led to weight loss in both groups. Ipragliflozin was safe and well-tolerated in Japanese patients with type 2 diabetes mellitus. This trial was registered with ClinicalTrials.gov (no. NCT00621868).

Indexed as

HyperglycemiaOral antidiabetic drugsSodium‐dependent glucose co‐transporter 2

Identifiers

PMID25411597
PMCPMC4210070

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Registered trials

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.