Evidence map›Paper›PMID 31742898›Full record

Trial reportDiabetes, obesity & metabolism2020

Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT-5): 52-week results from a randomized, open-label, phase III clinical trial.

Eiichi Araki, Hirotaka Watada, Yasuko Uchigata, Osamu Tomonaga, Hitomi Fujii, Hiroshi Ohashi, Tadashi Okabe, Michiko Asano, Fredrik Thoren, Hyosung Kim and 2 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 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

19 citing papers in PubMed, 1 synthesis or guideline 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

12 authors.

Eiichi ArakiDepartment of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.ORCID 0000-0002-4064-7525
Hirotaka WatadaDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0001-5961-1816
Yasuko UchigataDiabetes Center, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
Osamu TomonagaDiabetes and Lifestyle Center, Tomonaga Clinic, Tokyo, Japan.
Hitomi FujiiInternal Medicine, Tama-center Mirai Clinic, Tokyo, Japan.
Hiroshi OhashiInternal Medicine, Oyama East Clinic, Tochigi, Japan.
Tadashi OkabeOkabe Clinic, Tokyo, Japan.
Michiko AsanoResearch & Development, AstraZeneca K.K., Osaka, Japan.
Fredrik ThorenGlobal Medicine Development, AstraZeneca Gothenburg, Mölndal, Sweden.
Hyosung KimResearch & Development, AstraZeneca K.K., Osaka, Japan.
Toshitaka YajimaResearch & Development, AstraZeneca K.K., Osaka, Japan.
Anna Maria LangkildeGlobal Medicine Development, AstraZeneca Gothenburg, Mölndal, Sweden.

Funding

AstraZenecaAstraZeneca K.K.
6 · The paper itself

Abstract

aimsTo investigate the safety and tolerability of 5 and 10 mg dapagliflozin added to insulin therapy over 52 weeks in Japanese patients with inadequately controlled type 1 diabetes mellitus (T1DM). MATERIALS AND

methodsThis randomized, open-label, parallel-group, multicentre phase III clinical trial was conducted from October 26, 2015 to June 15, 2017. The primary endpoint was the occurrence of adverse events such as hypoglycaemia and diabetic ketoacidosis. Secondary endpoints included changes in glycaemic parameters, total daily insulin dosage and body weight over time. The efficacy of dapagliflozin in patients stratified by body mass index (BMI) <25.0 and ≥25.0 kg/m

resultsIn total, 151 patients received 5 mg (n = 76) or 10 mg (n = 75) dapagliflozin once daily for 52 weeks. Adverse events were observed in 88.2% and 73.3% of patients in the 5 and 10 mg dapagliflozin groups, respectively. Severe hypoglycaemia was reported in 2.6% (n = 2) and 6.7% (n = 5) of patients, and diabetic ketoacidosis in 2.6% (n = 2) and 1.3% (n = 1) of patients in the 5 and 10 mg dapagliflozin groups, respectively. The adjusted mean (95% confidence interval) changes in glycated haemoglobin at week 52 were -0.33% (-0.50, -0.15) and -0.36% (-0.53, -0.18) in the 5 and 10 mg dapagliflozin groups, respectively. There were no differences in efficacy parameters when stratified by BMI.

conclusionsThis study demonstrated the long-term safety and tolerability of dapagliflozin added to insulin therapy in Japanese patients with inadequately controlled T1DM.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Benzhydryl CompoundsGlucosidesHumansHypoglycemic AgentsJapanBenzhydryl CompoundsdapagliflozinGlucosidesHypoglycemic Agents

Identifiers

PMID31742898
PMCPMC7078973

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Registered trials

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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.