Evidence map›Paper›PMID 32623839›Full record

Trial reportJournal of diabetes investigation2021

Effects of ipragliflozin versus metformin in combination with sitagliptin on bone and muscle in Japanese patients with type 2 diabetes mellitus: Subanalysis of a prospective, randomized, controlled study (PRIME-V study).

Masaya Koshizaka, Ko Ishikawa, Ryoichi Ishibashi, Yoshiro Maezawa, Kenichi Sakamoto, Daigaku Uchida, Susumu Nakamura, Masaya Yamaga, Hidetaka Yokoh, Akina Kobayashi and 23 more

Open access · goldAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes investigation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 6 pooled it
2.3field-weighted citation impact, top 11% 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.

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

17 citing papers in PubMed, 6 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
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  6. Pooled it
  7. Trial
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  9. Article
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  14. Sarcopenia in elderly diabetes.Journal of diabetes investigation · 2022
    Article
  15. Secondary Osteoporosis and Metabolic Bone Diseases.Journal of clinical medicine · 2022
    Review
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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

33 authors at 15 institutions in 2 countries.

Masaya KoshizakaDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.ORCID https://orcid.org/0000-0001-7374-9993
Ko IshikawaDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.
Ryoichi IshibashiDepartment of Endocrinology, Hematology, and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.
Yoshiro MaezawaDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.ORCID https://orcid.org/0000-0001-5567-9901
Kenichi SakamotoDepartment of Endocrinology, Hematology, and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.
Daigaku UchidaHotaruno Central Naika, Kisarazu, Japan.
Susumu NakamuraOdayama Clinic, Kisarazu, Japan.
Masaya YamagaDepartment of Diabetes and Metabolism, Japanese Red Cross Narita Hospital, Narita, Japan.
Hidetaka YokohDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.ORCID https://orcid.org/0000-0002-6784-3243
Akina KobayashiDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.
Shunichiro OnishiDepartment of Diabetes and Metabolism, Asahi General Hospital, Asahi, Japan.
Kazuki KobayashiDepartment of Endocrinology, Hematology, and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.
Jun OginoDepartment of Diabetes, Endocrine and Metabolic Disease, Tokyo Women's Medical University Yachiyo Medical Center, Yachiyo, Japan.
Naotake HashimotoDepartment of Diabetes, Endocrine and Metabolic Disease, Tokyo Women's Medical University Yachiyo Medical Center, Yachiyo, Japan.
Hirotake TokuyamaYukarigaoka Tokuyama Medical Clinic, Sakura, Japan.
Fumio ShimadaDepartment of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, Chiba, Japan.
Emi OharaDepartment of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, Chiba, Japan.
Takahiro IshikawaDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.
Mayumi ShojiDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.
Shintaro IdeDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.
Kana IdeDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.
Yusuke BabaDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.ORCID https://orcid.org/0000-0001-9732-958X
Akiko HattoriDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.
Takumi KitamotoDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.
Takuro HorikoshiDiagnostic Radiology and Radiation Oncology, Chiba University Graduate School of Medicine, Chiba, Japan.
Ryouta ShimofusaDepartment of Radiology, Sannou Hospital, Chiba, Japan.
Sho TakahashiClinical Research Support Center, The Jikei University School of Medicine, Tokyo, Japan.
Kengo NagashimaResearch Center for Medical and Health Data Science, The Institute of Statistical Mathematics, Tachikawa, Japan.ORCID https://orcid.org/0000-0003-4529-9045
Yasunori SatoDepartment of Preventive Medicine and Public Health, Keio University School of Medicine, Shinjuku-ku, Japan.
Minoru TakemotoDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, International University of Health and Welfare, Narita, Japan.ORCID https://orcid.org/0000-0002-9599-2465
L Kristin NewbyDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.
Koutaro YokoteDepartment of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.ORCID https://orcid.org/0000-0003-3033-4813
PRIME-V study group
Chiba University · JPChiba East Hospital · JPTokyo Women's Medical University · JPAsahi General Hospital · JPChiba University Hospital · JPClinical Research Institute · USInternational University of Health and Welfare · JPJapanese Red Cross Narita Hospital · JPJikei University School of Medicine · JPKeio University · JPKisarazu Hospital · JPSanraku Hospital · JPSubaru (Japan) · JPThe Institute of Statistical Mathematics · JPTokuyama (Japan) · JP

Funding

Astellas Pharma Inc.
6 · The paper itself

Abstract

AIMS/

introductionRecent randomized clinical trials have suggested that sodium-glucose cotransporter 2 inhibitors might reduce cardiovascular events and heart failure, and have renal protective effects. Despite these remarkable benefits, the effects of sodium-glucose cotransporter 2 inhibitors on bone and muscle are unclear. MATERIALS AND

methodsA subanalysis of a randomized controlled study was carried out to evaluate the effects of the sodium-glucose cotransporter 2 inhibitor, ipragliflozin, versus metformin on bone and muscle in Japanese patients with type 2 diabetes mellitus (baseline body mass index ≥22 kg/m

resultsAfter 24 weeks of treatment, the changes in bone density of the fourth lumbar vertebra, handgrip strength and abdominal cross-sectional muscle area were not significantly different between the two groups. However, TRACP-5b levels increased in patients treated with ipragliflozin compared with patients treated with metformin (median 11.94 vs -10.30%, P < 0.0001), showing that ipragliflozin can promote bone resorption.

conclusionsThere were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin. However, ipragliflozin combination increased the levels of TRACP-5b. A long-term study is required to further understand the effects of this TRACP-5b increase caused by ipragliflozin.

Indexed as

AdultAgedBiomarkersBlood GlucoseBone and BonesCross-Sectional StudiesDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleFollow-Up StudiesGlucosidesHumansHypoglycemic AgentsMaleMetforminMiddle AgedBiomarkersBlood GlucoseGlucosidesHypoglycemic AgentsipragliflozinMetforminSitagliptin PhosphateSodium-Glucose Transporter 2 InhibitorsThiophenesBone metabolismMetforminSodium-glucose cotransporter 2 inhibitor

Identifiers

PMID32623839
PMCPMC7858125
OpenAlexW3040293817

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.