Evidence map›SGLT2 inhibitors × glycemic control›PMID 27316668›Full record

Trial reportCardiovascular diabetology2016

Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus.

Nobuya Inagaki, Shin-Ichi Harashima, Nobuko Maruyama, Yutaka Kawaguchi, Maki Goda, Hiroaki Iijima

Registry-linked trialOpen access · goldFull text readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cardiovascular diabetology, 2016. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It reports registered trial NCT02220920. Cited by 48 papers, 14 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
48citing papers in PubMed, 14 pooled it
8.7field-weighted citation impact, top 2% 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.

← favours the treatmentfavours the comparator →
-1.330 · no effect
Glycemic controlfavours the treatment · against placebo · obesity, t2dfeeds one cell of the map
placebo-adjusted change -1.10-1.33 to -0.87p < 0.001
The changes in HbA1c levels from the baseline at week 16 (LOCF, LS mean ± SE) were 0.13 ± 0.08 % in the placebo group and -0.97 ± 0.08 % in the canagliflozin group, corresponding to the placebo-adjusted changes of -1.10 % (95 % CI, -1.33 to -0.87; p < 0.001), which were statistically significant.
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 paper146 enrolled · 2014
placebo-adjusted change -1.10-1.33 to -0.87
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.

NCT02220920 phase4completed

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus

Ran2014Enrolled146Registered outcomes5Posted comparisons5ConditionsType 2 Diabetes MellitusArmsCanagliflozin (TA-7284), Insulin, Placebo
Open the trial in the graph
5 · Its place in the literature

Who cites it

48 citing papers in PubMed, 14 syntheses or guidelines pooled it, 69 citations in OpenAlex.

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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 at 2 institutions in 2 countries.

Nobuya InagakiDepartment of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Shin-Ichi HarashimaDepartment of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Nobuko MaruyamaClinical Research Department II, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Yutaka KawaguchiData Science Department, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Maki GodaMedical Science Center, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Hiroaki IijimaMedical Science Center, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. Iijima.Hiroaki@mm.mt-pharma.co.jp.ORCID http://orcid.org/0000-0003-4621-2394
Mitsubishi Group (Japan) · JPKyoto University · JP

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.

backgroundCombination therapy with canagliflozin and insulin was investigated in a prescribed substudy of the canagliflozin Cardiovascular Assessment Study (CANVAS); however, it was not evaluated in Japanese patients with type 2 diabetes mellitus (T2DM). Since the usage profile of insulin therapy and pathologic features of Japanese patients differ from those of Caucasian patients, we determined the clinical benefit of such a combination therapy in Japanese patients.

methodsPatients who had inadequate glycemic control despite insulin, diet and exercise therapies were randomized into placebo (n = 70) and canagliflozin 100 mg (n = 76) groups that were administered once daily in addition to their prior insulin therapy in this double-blind, placebo-controlled study. The primary endpoint was the change in glycated hemoglobin (HbA1c) levels from the baseline to week 16.

resultsThere was a statistically significant decrease in HbA1c levels from the baseline in the canagliflozin group (-0.97 ± 0.08 %) compared with the placebo group (0.13 ± 0.08 %) at week 16 [last observation carried forward (LOCF)]. The decrease in HbA1c levels in the canagliflozin group was independent of the insulin regimen (premixed, long-acting and long-acting plus rapid- or short-acting). Compared with the placebo group, canagliflozin significantly decreased fasting plasma glucose levels (-34.1 ± 4.8 vs -1.4 ± 5.0 mg/dL) and body weights (-2.13 ± 0.25 vs 0.24 ± 0.26 %), and significantly increased HDL cholesterol (3.3 ± 1.0 vs -0.5 ± 1.0 mg/dL) and HOMA2- %B (10.15 ± 1.37 vs 0.88 ± 1.42 %). The overall incidence of adverse events was similar between the two groups. The incidence and incidence per subject-year exposure of hypoglycemia (hypoglycemic symptoms and/or decreased blood glucose) were slightly higher in the canagliflozin group (40.0 % and 7.97) than in the placebo group (29.6 % and 4.51). However, hypoglycemic events in both groups were mild in severity and dose-reduction of insulin by <10 % from the baseline following hypoglycemic events decreased the incidence per subject-year exposure in the canagliflozin group. The incidence of hypoglycemia between the groups did not differ according to the insulin regimen.

conclusionCanagliflozin in combination with insulin was effective in improving glycemic control and reducing body weight and well tolerated by Japanese patients with T2DM. Trial Registration ClinicalTrials.gov identifier: NCT02220920.

Indexed as

AdultAgedAsian PeopleBlood GlucoseBody WeightCanagliflozinDiabetes Mellitus, Type 2Double-Blind MethodFemaleHumansHypoglycemiaHypoglycemic AgentsInsulinMaleMiddle AgedWeight LossBlood GlucoseCanagliflozinHypoglycemic AgentsInsulinCanagliflozinCombination therapyInsulinJapanese patientsSGLT2 inhibitorType 2 diabetes mellitus

Identifiers

PMID27316668
PMCPMC4912792
OpenAlexW2434919988

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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.