Evidence map›Paper›PMID 30800563›Full record

ArticleDiabetology international2019

Metformin monotherapy in children and adolescents with type 2 diabetes mellitus in Japan.

Nobuo Matsuura, Shin Amemiya, Shigetaka Sugihara, Tatsuhiko Urakami, Nobuyuki Kikuchi, Hiroshi Kato, Yasuhide Yodo, Study Group of the Pediatric Clinical Trial of Metformin in Japan

Open access · bronzeAbstract read
In one paragraph

Article in Diabetology international, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 32% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Article
  4. Article
  5. Treatment strategy for children and adolescents with type 2 diabetes-based on ISPAD Clinical Practice Consensus Guidelines 2022.Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology · 2023
    Review
  6. Review
  7. Review
  8. Article
  9. 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

8 authors at 6 institutions in 1 country.

Nobuo Matsuura1Department of Early Childhood Education, Seitoku University, Matsudo, Japan.
Shin Amemiya2Department of Pediatrics, Saitama Medical University, Saitama, Japan.
Shigetaka Sugihara3Department of Pediatrics, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.
Tatsuhiko Urakami4Department of Pediatrics and Child Health, Nihon University School of Medicine, Tokyo, Japan.
Nobuyuki KikuchiDepartment of Pediatrics, Yokohama City Minato Red Cross Hospital, Yokohama, Japan.
Hiroshi Kato6Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.
Yasuhide Yodo6Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.
Study Group of the Pediatric Clinical Trial of Metformin in Japan
Sumitomo Dainippon Pharma (Japan) · JPNihon University · JPSaitama Medical University · JPSeitoku University · JPTokyo Women's Medical University Adachi Medical Center · JPYokohama Municipal Minato Red Cross Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and effectiveness of metformin monotherapy for 52 weeks, including 24 weeks of treatment and a 28-week extension period for evaluation of long-term safety, in 37 Japanese pediatric patients with type 2 diabetes mellitus. RESEARCH DESIGN AND

methodsThis study design was an open-label, non-randomized, multicenter trial. The primary effectiveness endpoint was the changes from baseline to the final visit at 24 weeks in HbA1c. The secondary endpoints were the rate for achieving the treatment goal, and the changes in glycated albumin, fasting blood glucose, fasting insulin, HOMA-IR, and fasting serum lipids. Metformin was administrated at the dose of 500 mg/day up to a maximum of 2000 mg/day taken in two or three divided doses.

resultsThe mean change of HbA1c at the final visit at 24 weeks for 20 metformin-naïve patients (Group A) was - 0.66 ± 0.95% and that of 17 already-on metformin patients (Group B) was - 0.98 ± 1.62%. These figures proved the effectiveness of metformin as defined before the study. Secondary effectiveness endpoints were also improved. The improvement of blood glucose, fasting insulin and serum lipid levels proved the effectiveness of metformin without increasing body weight. Adverse effects such as nausea and diarrhea were observed in 35 of the 37 subjects and drug-related adverse events were observed in 19 patients. However, these events were not serious and did not increase with long-term treatment.

conclusionsMetformin is safe and effective for Japanese pediatric patients with T2DM.

Indexed as

Adverse effectsChildhood and adolescent T2DMMetforminMetformin monotherapySafety

Identifiers

PMID30800563
PMCPMC6357240
OpenAlexW2810443031

What OpenQuestion holds

Textmetadata
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.