Evidence map›Paper›PMID 30672128›Full record

Trial reportJournal of diabetes investigation2019

Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double-blind, placebo-controlled phase III study in Asian patients.

Masayuki Baba, Norimitsu Matsui, Masanori Kuroha, Yosuke Wasaki, Shoichi Ohwada

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 78 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 7 pooled it
7.7field-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.

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.

NCT02318706 phase3completednot on this map

An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Diabetic Peripheral Neuropathic Pain Followed by a 52-Week Open-label Extension

TypeinterventionalSponsorDaiichi Sankyo Co., Ltd.Ran2015 to 2017Enrolled854ConditionsDiabetic Peripheral Neuropathic PainArmsDS-5565, placebo
NCT07451431 phase4recruitingnot on this mapstarted 2025, after this paper: background citation

Efficacy, Safety and Patient-Reported Outcomes of Mirogabalin in Diabetic Peripheral Neuropathic Pain

TypeinterventionalSponsorBangladesh Medical UniversityRan2025 to 2027Enrolled78ConditionsDiabetic Peripheral Neuropathic Pain (DPNP)ArmsMirogabalin, Pregabalin
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 7 syntheses or guidelines pooled it, 129 citations in OpenAlex.

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18 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

5 authors at 2 institutions in 2 countries.

Masayuki BabaAomori Prefectural Central Hospital, Aomori, Japan.
Norimitsu MatsuiClinical Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Masanori KurohaClinical Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Yosuke WasakiAsia Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Shoichi OhwadaBiostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Daiichi-Sankyo (Japan) · JPAomori Prefectural Central Hospital · JP

Funding

Daiichi Sankyo, Inc.
6 · The paper itself

Abstract

AIMS/

introductionThis study evaluated the efficacy and safety of mirogabalin, a novel, potent, selective ligand of the α MATERIALS AND

methodsDuring this double-blind, multisite, placebo-controlled phase III study, Asian patients aged ≥20 years with type 1 or 2 diabetes and DPNP were randomized 2:1:1:1 to a placebo, mirogabalin 15, 20 or 30 mg/day for up to 14 weeks, with a 1- to 2-week titration (NCT02318706). The primary endpoint was the change from baseline in average daily pain score (ADPS) at week 14, defined as a weekly average of daily pain (0 = no pain to 10 = worst possible pain, for the past 24 h).

resultsOf 834 randomized patients, 330, 164, 165 and 165 received placebo, mirogabalin 15, 20 or 30 mg/day, respectively, and were included in analyses (modified intention-to-treat population, n = 824); 755 (90.5%) completed the study. At week 14, the least squares mean average daily pain score change from baseline was -1.31, -1.34, -1.47 and -1.81, respectively, showing statistical significance for mirogabalin 30 mg/day versus placebo (P = 0.0027). The treatment-emergent adverse events observed were mostly mild-to-moderate in all mirogabalin doses, and the most frequent treatment-emergent adverse events were nasopharyngitis, somnolence, dizziness, peripheral edema and weight increase.

conclusionsMirogabalin relieved DPNP in a dose-dependent manner; mirogabalin 30 mg/day showed statistically significant pain relief (vs placebo) in Asian DPNP patients. All doses of mirogabalin tested were well tolerated.

Indexed as

AdolescentAdultAgedAsian PeopleBridged Bicyclo CompoundsDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic NeuropathiesDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedNeuralgiaBridged Bicyclo CompoundsmirogabalinDiabetic peripheral neuropathic painMirogabalinPain

Identifiers

PMID30672128
PMCPMC6717827
OpenAlexW2912943392

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.