Evidence map›Paper›PMID 31173455›Full record

Trial reportDiabetes, obesity & metabolism2019

Efficacy and safety of ipragliflozin add-on therapy to insulin in Japanese patients with type 1 diabetes mellitus: A randomized, double-blind, phase 3 trial.

Kohei Kaku, Hiroyuki Isaka, Taishi Sakatani, Junko Toyoshima

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 5 pooled it
4.6field-weighted citation impact, top 4% 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

26 citing papers in PubMed, 5 syntheses or guidelines pooled it, 46 citations in OpenAlex.

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  20. Carbohydrate-based drugs launched during 2000Acta pharmaceutica Sinica. B · 2022
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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 at 2 institutions in 1 country.

Kohei KakuDepartment of Medicine, Kawasaki Medical School, Okayama, Japan.ORCID 0000-0003-1574-0565
Hiroyuki IsakaJapan/Asia Clinical Development, Astellas Pharma Inc., Tokyo, Japan.
Taishi SakataniData Science, Astellas Pharma Inc., Tokyo, Japan.
Junko ToyoshimaClinical Pharmacology and Exploratory Development, Astellas Pharma Inc., Tokyo, Japan.
Astellas Pharma (Japan) · JPKawasaki Medical School · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo assess the efficacy and safety of once-daily ipragliflozin 50 mg versus placebo in Japanese people with type 1 diabetes mellitus (T1DM) inadequately controlled with insulin. MATERIALS AND

methodsWe conducted a multicentre, double-blind, parallel-group, placebo-controlled phase 3 study. Participants (N = 175) were randomized (2:1) to receive once-daily ipragliflozin 50 mg (n = 115) or placebo (n = 60), combined with insulin, for 24 weeks. The primary endpoint was change in glycated haemoglobin (HbA1c); key secondary endpoints included change in insulin dose and body weight. Treatment-emergent adverse events (TEAEs) were evaluated.

resultsThe ipragliflozin group demonstrated a significant decrease in HbA1c from baseline to end of treatment versus the placebo group: adjusted mean difference (AMD) -3.8 mmol/mol (95% confidence interval [CI] -6.2, -1.5) or - 0.36% (95% CI -0.57, -0.14; P = 0.001). Significant reductions in total daily insulin dose (AMD -7.35 IU [95% CI -9.09, -5.61]; P < 0.001) and body weight (AMD -2.87 kg [95% CI -3.58, -2.16]; P < 0.001) were observed for the ipragliflozin group versus placebo. Two serious TEAEs occurred (major hypoglycaemia and abdominal abscess); both were in the placebo group. All other TEAEs were mild or moderate in severity. Four cases of study discontinuation occurred; three in the placebo group and one in the ipragliflozin group. No diabetic ketoacidosis was reported for any participant in this study.

conclusionsDaily ipragliflozin 50 mg in combination with insulin significantly reduced HbA1c, daily insulin dose and body weight versus placebo in people with T1DM. No safety concerns were identified after 24 weeks of treatment. Overall, once-daily ipragliflozin 50 mg was both efficacious and well tolerated.

Indexed as

GlucosidesHypoglycemic AgentsInsulinThiophenesAdultBody WeightDiabetes Mellitus, Type 1FemaleGlycated HemoglobinHumansJapanMaleMiddle AgedGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinipragliflozinThiophenesantidiabetic drugclinical trialinsulin therapyphase III studySGLT2 inhibitortype 1 diabetes

Identifiers

PMID31173455
PMCPMC6772182
OpenAlexW2948687643

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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 Socratic graph.