Evidence map›Paper›PMID 31933070›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2020

Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes and Renal Dysfunction: a Post-Marketing Surveillance Study.

Fumiko Yamamoto, Rie Ikeda, Kaori Ochiai, Tetsuaki Hirase, Naoyuki Hayashi, Tomoo Okamura

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01650259 (Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

NCT01650259 completednot on this map

Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus

TypeobservationalSponsorBoehringer IngelheimRan2012 to 2017Enrolled4,876ConditionsDiabetes Mellitus, Type 2ArmsOAD, Trazenta
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Review
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

6 authors at 2 institutions in 1 country.

Fumiko YamamotoMedicine Division, Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan. fumiko.yamamoto@boehringer-ingelheim.com.
Rie IkedaMedicine Division, Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.
Kaori OchiaiPMS Division, EPS Corporation, Tokyo, Japan.
Tetsuaki HiraseMedicine Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Naoyuki HayashiMedicine Division, Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.
Tomoo OkamuraMedicine Division, Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.
Boehringer Ingelheim (Japan) · JPEli Lilly (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInternational clinical trials have shown that linagliptin significantly improves glycemic control and can be used at a single dose regardless of renal function in patients with type 2 diabetes (T2D). However, to date, no studies have evaluated the use of linagliptin in Japanese patients with T2D by renal function in routine clinical care.

methodsThis was a subgroup analysis of data from a prospective observational post-marketing surveillance (PMS) study of linagliptin conducted in Japan that evaluated the safety and effectiveness of linagliptin in routine clinical care for 3 years in Japanese patients with T2D. The subgroup analysis examined the patient population of this PMS study according to renal function using estimated glomerular filtration rate (eGFR) data. The incidence of linagliptin-related adverse events (adverse drug reactions [ADRs]) was the primary endpoint, and the change in glycated hemoglobin (HbA1c) from baseline to last observation was the secondary endpoint.

resultsOf the 2235 patients included in the safety analysis, eGFR was ≥ 90 mL/min/1.73 m

conclusionsLong-term linagliptin use showed sustained improvements in glycemic control with no new safety concerns regardless of renal function.

trial registrationClinicalTrials.gov (NCT01650259).

fundingThis study was funded by Nippon Boehringer Ingelheim Co., Ltd. and Eli Lilly Japan K.K.

Indexed as

EffectivenessLinagliptinLong-termRenal functionSafetyType 2 diabetes

Identifiers

PMID31933070
PMCPMC6995795
OpenAlexW3000283549

What OpenQuestion holds

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LicenceCC BY-NC
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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.