Evidence mapPaperPMID 29110384Full record

Trial reportDiabetes, obesity & metabolism2018

Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus.

Nobuya Inagaki, Shin-Ichi Harashima, Kohei Kaku, Kazuoki Kondo, Nobuko Maruyama, Makiko Otsuka, Yutaka Kawaguchi, Hiroaki Iijima

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02622113. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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.

NCT02622113 phase4completed

An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus

Ran2014Enrolled139Registered outcomes4Posted comparisons0ConditionsType 2 Diabetes MellitusArmsCanagliflozin (TA-7284), Insulin
Open the trial in the graph
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Treatment Preferences for Novel Type 2 Diabetes Oral Medications: Insights from the Asian Diabetes Patient Preference Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Article
  6. Article
  7. Review
  8. Article
  9. Article
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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

8 authors at 3 institutions in 1 country.

Nobuya InagakiDepartment of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0001-8261-2593
Shin-Ichi HarashimaDepartment of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0003-4813-0085
Kohei KakuDepartment of General Internal Medicine 1, Kawasaki Medical School, Okayama, Japan.ORCID 0000-0003-1574-0565
Kazuoki KondoIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Nobuko MaruyamaIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Makiko OtsukaIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Yutaka KawaguchiIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Hiroaki IijimaIkuyaku Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.ORCID 0000-0003-4621-2394
Mitsubishi Group (Japan) · JPKyoto University · JPKawasaki Medical School · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe aim of this study was to assess the long-term efficacy and safety of canagliflozin as add-on therapy in Japanese patients with type 2 diabetes mellitus who had inadequate glycaemic control with insulin. MATERIALS AND

methodsThe study comprised a 16-week, double-blind period in which patients were randomized to either placebo (P; N = 70) or canagliflozin (100 mg, CAN; N = 76), followed by a 36-week open-label period in which all patients received canagliflozin. The efficacy endpoints included the change in HbA1c from baseline to end of treatment. The safety endpoints were adverse events, hypoglycaemic events, and laboratory test values.

resultsThe changes from baseline (mean ± standard deviation, last observation carried forward) in the P/CAN and CAN/CAN groups, respectively, were -1.09% ± 0.85% and -0.88% ± 0.86% for HbA1c, -1.40% ± 2.54% and -2.14% ± 2.75% for body weight, and 7.84% ± 14.37% and 8.91% ± 10.80% for HOMA2-%B (all, P < .001). Adverse events occurred in 85.1% of the P/CAN group and 92.0% of the CAN/CAN group. Hypoglycaemic events occurred in 43.3% and 54.7%, respectively. All hypoglycaemic events were mild in severity and insulin dose reduction decreased the incidence rate of hypoglycaemic events. Post-hoc ordinal logistic modelling/logistic modelling showed that lower serum C-peptide at Week 0 was a risk factor for hypoglycaemia in both the P and CAN groups in the double-blind period as well as in the canagliflozin all-treatment period.

conclusionsThis study demonstrates the long-term efficacy and safety of canagliflozin combined with insulin in Japanese patients.

Indexed as

AdultAsian PeopleBlood GlucoseCanagliflozinDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansInsulinJapanMaleMiddle AgedTime FactorsTreatment OutcomeBlood GlucoseCanagliflozinGlycated HemoglobinInsulincanagliflozinhypoglycaemiainsulinSGLT2 inhibitortype 2 diabetes mellitus

Identifiers

PMID29110384
PMCPMC5873413
OpenAlexW2767544488

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

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 Socratic graph.