Evidence map›SGLT2 inhibitors × glycemic control›PMID 27330723›Full record

Trial reportJournal of diabetes investigation2016

Efficacy, safety, and tolerability of ipragliflozin in Asian patients with type 2 diabetes mellitus and inadequate glycemic control with metformin: Results of a phase 3 randomized, placebo-controlled, double-blind, multicenter trial.

Chieh-Hsiang Lu, Kyung Wan Min, Lee-Ming Chuang, Satoshi Kokubo, Satoshi Yoshida, Bong-Soo Cha

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes investigation, 2016. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. Cited by 36 papers, 16 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
36citing papers in PubMed, 16 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.

← favours the treatmentfavours the comparator →
-0.460 · no effect
Glycemic controlfavours the treatment · against placebo · t2dfeeds one cell of the map
Δ -0.46P < 0.001
The mean changes (standard deviation) in hemoglobin A1c were -0.94% (0.75%) and -0.47% (0.81%) in the ipragliflozin and placebo groups, respectively (between-group difference -0.46%, P < 0.001).
FeedsSGLT2 inhibitors×glycemic control

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

SGLT2 inhibitors×glycemic control

SupportsOpen on the map →What to test next →

40 readable studies in this cell: 80 favour the treatment, 11 find no difference, 4 favour the comparator.

Belief with this paper
0.92replicated · 69 families support, 6 contradict · against placebo
Without it
0.92This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2016
Δ -0.46
NCT010326294,330 enrolled · 2009
Δ 2.79-1.57 to 7.15
NCT011374742,996 enrolled · 2010
Δ -0.46-0.59 to -0.33
NCT011956622,245 enrolled · 2010
Δ -0.61-0.76 to -0.46
NCT010956661,484 enrolled · 2010
Δ -0.59-0.76 to -0.42
NCT009688121,452 enrolled · 2009
Δ -0.01-0.11 to 0.09
NCT017190031,413 enrolled · 2012
Adjusted mean -0.33-0.56 to -0.10
NCT011066771,284 enrolled · 2010
Δ -0.62-0.76 to -0.48
NCT016060071,282 enrolled · 2012
Δ -0.59-0.81 to -0.37
NCT006732311,240 enrolled · 2008
Δ -0.45-0.59 to -0.31
NCT020991101,233 enrolled · 2014
Δ -0.43-0.60 to -0.27
NCT006609071,217 enrolled · 2008
Δ 0.00-0.11 to 0.11
NCT018093271,186 enrolled · 2013
Δ -0.46-0.66 to -0.27
4 · 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.

5 · Its place in the literature

Who cites it

36 citing papers in PubMed, 16 syntheses or guidelines pooled it.

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  17. Trial
  18. Trial
  19. Article
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6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

6 authors.

Chieh-Hsiang LuDepartment of Internal Medicine Ditmanson Medical Foundation Chiayi Christian Hospital Chiayi City Taiwan; College of Management Department of Business Administration National Chung Cheng University Chia-yi County Taiwan; Department of Nursing and Health Management Da-Yeh University Changhua County Taiwan.
Kyung Wan MinDepartment of Internal Medicine Eulji General Hospital Seoul Korea.
Lee-Ming ChuangDepartment of Internal Medicine National Taiwan University Hospital Taipei Taiwan.
Satoshi KokuboAstellas Pharma Inc. Tokyo Japan.
Satoshi YoshidaAstellas Pharma Inc. Tokyo Japan.
Bong-Soo ChaDivision of Endocrinology and Metabolism Department of Internal Medicine Yonsei University College of Medicine Seoul Korea.

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

AIMS/

introductionTo determine the efficacy and safety of ipragliflozin in combination with metformin in Asian patients with type 2 diabetes mellitus. MATERIALS AND

methodsThis phase 3, multicenter, placebo-controlled, double-blind, parallel-group study was carried out at 18 sites in Korea and 12 sites in Taiwan. After an 8-week washout period for patients using drugs other than metformin and a 2-week run-in period, patients were randomized to either 50 mg ipragliflozin or a placebo for 24 weeks while continuing metformin. Efficacy outcomes included the changes in hemoglobin A1c, fasting plasma glucose (FPG) and bodyweight from baseline to the end of treatment (with last observation carried forward). Safety outcomes included treatment-emergent adverse events.

resultsBetween November 2011 and January 2013, 171 patients were randomized to and administered ipragliflozin (n = 87) or a placebo (n = 83). The mean changes (standard deviation) in hemoglobin A1c were -0.94% (0.75%) and -0.47% (0.81%) in the ipragliflozin and placebo groups, respectively (between-group difference -0.46%, P < 0.001). The changes in fasting plasma glucose and bodyweight were also significantly greater in the ipragliflozin group, with between-group differences of -14.1 mg/dL and -1.24 kg, respectively (both P < 0.001). The most common treatment-emergent adverse events (ipragliflozin vs placebo) were upper respiratory tract infection (9.2% vs 12.0%) and urinary tract infection (6.9% vs 2.4%).

conclusionsThese results show that ipragliflozin is effective and well tolerated when used in combination with metformin in Asian patients with type 2 diabetes mellitus.

Indexed as

Asian PeopleDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlucosidesHumansMaleMetforminThiophenesTreatment OutcomeGlucosidesipragliflozinMetforminThiophenesAsiaIpragliflozinType 2 diabetes mellitus

Identifiers

PMID27330723
PMCPMC4847891

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
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.