Evidence map›Paper›PMID 27436788›Full record

Trial reportDiabetes, obesity & metabolism2016

Efficacy and safety of ipragliflozin as add-on therapy to insulin in Japanese patients with type 2 diabetes mellitus (IOLITE): a multi-centre, randomized, placebo-controlled, double-blind study.

Hisamitsu Ishihara, Susumu Yamaguchi, Ikko Nakao, Akira Okitsu, Seitaro Asahina

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 8 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.

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

31 citing papers in PubMed, 8 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

5 authors.

Hisamitsu IshiharaDivision of Diabetes and Metabolic Diseases, Nihon University School of Medicine, Tokyo, Japan.
Susumu YamaguchiAstellas Pharma Inc., Tokyo, Japan.
Ikko NakaoAstellas Pharma Inc., Tokyo, Japan.
Akira OkitsuAstellas Pharma Inc., Tokyo, Japan.
Seitaro AsahinaAstellas Pharma Inc., Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo examine the efficacy and safety of add-on ipragliflozin in Japanese patients with type 2 diabetes in the early stage of insulin therapy.

methodsPatients treated with insulin (bolus component <30% of total daily dose) with/without a dipeptidyl peptidase-4 (DPP-4) inhibitor were randomized to receive placebo (n = 87) or ipragliflozin (n = 175) for 16 weeks. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline. Secondary endpoints included changes in fasting plasma glucose (FPG) and metabolic hormones. Safety endpoints were also examined.

resultsThe changes in HbA1c were 0.27% and -0.79% (2.9 and -8.7 mmol/mol) in the placebo and ipragliflozin groups, respectively (baseline: 8.62% vs 8.67% [70.8 vs 71.2 mmol/mol]), corresponding to an adjusted mean difference of -1.07% (95% confidence interval -1.24, -0.91) or -11.7 mmol/mol (-13.5, -9.9), p < .001. Ipragliflozin reduced FPG and serum C-peptide levels and body weight (all p < .001), and increased serum adiponectin levels (p = .022). There was a statistically significant interaction for use/non-use of a DPP-4 inhibitor × treatment group for the change in HbA1c (p = .042). Hypoglycaemia was the only treatment-related adverse event reported in >5% of patients (14.9% vs 29.1%). Events consistent with urinary tract infection (placebo 1.1% vs ipragliflozin 2.3%) or genital infection (0.0% and 4.0%, respectively) occurred in <5% of patients.

conclusionIpragliflozin was well tolerated and effective in insulin-treated patients, especially when used with a DPP-4 inhibitor.

Indexed as

AdiponectinAgedAsian PeopleBlood GlucoseBody WeightC-PeptideDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodDrug Therapy, CombinationFastingFemaleGlucosidesGlycated HemoglobinHumansHypoglycemiaAdiponectinBlood GlucoseC-PeptideDipeptidyl-Peptidase IV InhibitorsGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinipragliflozinThiophenesDPP-4 inhibitorinsulin therapySGLT2 inhibitortype 2 diabetes

Identifiers

PMID27436788
PMCPMC5484364

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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.