Evidence map›Paper›PMID 23194084›Full record

Trial reportDiabetes, obesity & metabolism2013

Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control: a phase II multicentre, randomized, double-blind, placebo-controlled trial.

K Kaku, S Inoue, O Matsuoka, A Kiyosue, H Azuma, N Hayashi, T Tokudome, A M Langkilde, S Parikh

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02113241 (Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion), which is not on this map. Cited by 62 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 21 pooled it
8.4field-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.

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.

NCT02113241 phase2 / phase3completedstarted 2014, after this paper: background citation

Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion

Ran2014Enrolled24Registered outcomes24Posted comparisons48ConditionsMetabolic Syndrome XArmsdapagliflozin, Placebo
PMID 24463448PMID 23906445PMID 22238392PMID 24105299PMID 24130972PMID 23910664PMID 23668478PMID 23210765PMID 22701099PMID 22446170PMID 20566676PMID 20518806other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 21 syntheses or guidelines pooled it, 135 citations in OpenAlex.

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2 more citing papers are in PubMed but not listed here.

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

9 authors at 5 institutions in 5 countries.

K KakuDepartment of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Okayama, Japan. kka@med.kawasaki-m.ac.jp
S Inoue
O Matsuoka
A Kiyosue
H Azuma
N Hayashi
T Tokudome
A M Langkilde
S Parikh
AstraZeneca (Germany) · DEAstraZeneca (Japan) · JPAstraZeneca (Sweden) · SEBristol-Myers Squibb (Japan) · JPKawasaki Medical School · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimDapagliflozin is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor under development as a treatment for type 2 diabetes mellitus (T2DM). This study assessed the efficacy and safety of dapagliflozin monotherapy in Japanese T2DM patients with inadequate glycaemic control.

methodsPatients (n = 279) were randomized to receive dapagliflozin (1, 2.5, 5 or 10 mg/day) or placebo once daily for 12 weeks. The primary endpoint was change from baseline in haemoglobin A1c (HbA1c) at week 12. Secondary endpoints included change from baseline in fasting plasma glucose (FPG) and proportion of patients achieving HbA1c <7.0% at week 12.

resultsSignificant reductions in HbA1c were seen with all dapagliflozin doses (-0.11 to -0.44%) versus placebo (+0.37%). Reductions were also observed in FPG with dapagliflozin (-0.87 to -1.77 mmol/l [-15.61 to -31.94 mg/dl]) versus placebo (+0.62 mmol/l [+11.17 mg/dl]). No significant difference in the proportion of patients achieving HbA1c levels <7.0% was noted with dapagliflozin versus placebo. Adverse events (AEs) were more frequent with dapagliflozin (40.7-53.8%) versus placebo (38.9%) and were mostly mild/moderate in intensity. Three hypoglycaemic events were reported (1 each with placebo, dapagliflozin 2.5 mg and 10 mg). The frequency of signs and symptoms suggestive of urinary tract or genital infections was 0-3.8 and 0-1.8% respectively with dapagliflozin and 1.9 and 0% with placebo. No AEs of pyelonephritis were observed.

conclusionsCompared with placebo, dapagliflozin significantly reduced hyperglycaemia over 12 weeks with a low risk of hypoglycaemia in Japanese T2DM patients with inadequate glycaemic control.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAdolescentAdultAgedAsian PeopleBenzhydryl CompoundsBiomarkersBlood GlucoseBody WeightDiabetes Mellitus, Type 2Double-Blind MethodFastingFemaleGlucosidesGlycated HemoglobinHumansBenzhydryl CompoundsBiomarkersBlood GlucosedapagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID23194084
OpenAlexW2120649968

What Socratic holds

Textmetadata
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.