Evidence map›Paper›PMID 30943275›Full record

Trial reportPloS one2019

Effects of azilsartan compared with telmisartan on insulin resistance in patients with essential hypertension and type 2 diabetes mellitus: An open-label, randomized clinical trial.

Mitsuhide Naruse, Yasuhiro Koike, Nozomu Kamei, Ryuichi Sakamoto, Yuko Yambe, Michinori Arimitsu

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02079805 (A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.9field-weighted citation impact, top 13% 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.

NCT02079805 phase4completednot on this map

A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R

TypeinterventionalSponsorTakedaRan2014 to 2016Enrolled33ConditionsEssential Hypertension Complicated by Type 2 Diabetes MellitusArmsAzilsartan, Telmisartan
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Multi-Target Approaches in Metabolic Syndrome.Frontiers in pharmacology · 2020
    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 5 institutions in 1 country.

Mitsuhide NaruseDivision of Endocrinology, Metabolism, and Hypertension, Clinical Research Institute for Endocrine and Metabolic Diseases, National Hospital Organization, Kyoto Medical Center, Kyoto, Japan.ORCID 0000-0002-8977-4090
Yasuhiro KoikeJapan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Nozomu KameiDepartment of Endocrinology and Metabolism, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan.
Ryuichi SakamotoDepartment of Endocrinology and Metabolism, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.ORCID 0000-0002-8276-9678
Yuko YambeDepartment of Endocrinology and Diabetes, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Michinori ArimitsuData Science Division, Biostatistics Department I, A2 Healthcare Corporation, Tokyo, Japan.
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital · JPKyoto Medical Center · JPNational Hospital Organization · JPNational Kyushu Medical Center · JPTakeda (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBased on non-clinical data, it is expected that azilsartan, an angiotensin II receptor blocker, will help improve insulin resistance in addition to its hypotensive action. The present study is aimed to explore the effect of azilsartan compared to telmisartan on insulin sensitivity in hypertensive patients in the clinical setting.

methodsThis multicenter, randomized, open-label, parallel-group exploratory study was conducted in Japan. We randomized adult patients (≥20 years old) with grade I or II essential hypertension and coexisting type 2 diabetes (1:1) to receive either oral azilsartan (20 mg/day;17 patients) or telmisartan (40 mg/day;16 patients) for 12 weeks. The primary endpoint was the change in the homeostasis model assessment ratio of insulin resistance (HOMA-R) from the baseline at the end of the treatment period. We also evaluated its safety and efficacy on other diabetes-related variables and blood pressure.

findingsThe mean changes in HOMA-R at the end of treatment were 0.22 (95% CI, -1.09-1.52) in the azilsartan group and -0.23 (95% CI, -0.72-0.27) in the telmisartan group. We found no clinically remarkable changes between the groups in diabetes-related variables such as fasting blood glucose, fasting insulin, HbA1c (NGSP), HOMA-β, or 1,5-anhydroglucitol. Reductions in clinic systolic and diastolic blood pressure were observed at week 4 and the reduced levels were maintained throughout the treatment period in both groups. No serious treatment-emergent adverse events (TEAEs) were observed. Only one drug-related TEAE (mild decrease in blood pressure) was reported in one patient in the azilsartan group.

conclusionNeither azilsartan nor telmisartan had any clinically remarkable effects on insulin resistance parameters when administered for 12 weeks to patients with grade I or II essential hypertension and coexisting type 2 diabetes mellitus. Azilsartan (20 mg/day) and telmisartan (40 mg/day) exerted comparable antihypertensive effects.

trial registrationClinicalTrials.gov NCT02079805.

Indexed as

Insulin ResistanceAdultAgedAged, 80 and overBenzimidazolesBlood PressureDiabetes Mellitus, Type 2FemaleHumansHypertensionMaleMiddle AgedOxadiazolesTelmisartanazilsartanBenzimidazolesOxadiazolesTelmisartan

Identifiers

PMID30943275
PMCPMC6447197
OpenAlexW2926498455

What OpenQuestion holds

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LicenceCC BY
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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.