Evidence map›Paper›PMID 33730337›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2021

A Real-World, Observational Study of the Initiation, Use, and Effectiveness of Basal-Bolus or Premixed Insulin in Japanese People with Type 2 Diabetes.

Hideaki Miyoshi, Mike Baxter, Takeshi Kimura, Masakatsu Hattori, Yukiko Morimoto, Dion Marinkovich, Masami Tamiwa, Takahisa Hirose

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 37% 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
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 5 institutions in 3 countries.

Hideaki MiyoshiDivision of Diabetes and Obesity, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan. hmiyoshi@med.hokudai.ac.jp.ORCID http://orcid.org/0000-0002-5909-3243
Mike BaxterSanofi, Reading, UK.
Takeshi KimuraResearch and Analytics Department, Real World Data Co., Ltd., Kyoto, Japan.
Masakatsu HattoriSales and Business Solutions, Real World Data Co., Ltd., Kyoto, Japan.
Yukiko MorimotoSanofi K.K., Tokyo, Japan.
Dion MarinkovichSanofi Australia and New Zealand, Sydney, Australia.
Masami TamiwaSanofi K.K., Tokyo, Japan.
Takahisa HiroseDivision of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University Graduate School of Medicine, Tokyo, Japan.
Sanofi (Japan) · JPHokkaido University · JPSanofi (Australia) · AUSanofi (United Kingdom) · GBToho University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBasal-bolus (BB) and premixed insulin regimens may lower fasting plasma glucose (FPG) and postprandial plasma glucose (PPG), but are complex to use and associated with weight gain and hypoglycaemia. Although randomized controlled trials and prospective observational studies in insulin-naïve Japanese patients with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs (OADs) initiating these regimens have been conducted, real-world data are lacking. This study describes the characteristics of patients initiating these regimens in routine clinical practice and identifies the course and outcomes of therapy in the year following initiation.

methodsAdults with T2D initiating BB or premixed regimens following OAD therapies held in a Japanese electronic medical record database were identified (2010-2019). Subcohorts were determined by treatment changes during ≤ 12 months of follow-up (no change, intensified, switched, discontinued). Outcomes included change in glycated haemoglobin levels (HbA1c), probability of first reaching HbA1c < 7% (stratified by baseline OAD number, HbA1c and age), and hypoglycaemia incidence.

resultsThe main cohorts comprised 1315 BB and 1195 premixed therapy initiators. Most individuals (67.9%) initiated BB as inpatients; 50.8% switched at a mean of 47.6 days. Mean HbA1c lowering was  - 2.5% for BB and  - 1.4% for premixed regimens (no change cohorts). Overall, a greater proportion achieved HbA1c < 7% if they were (at baseline) taking fewer OADs, in a lower HbA1c category, and aged ≥ 65 years. Hypoglycaemia incidence (< 70 mg/dl) was higher with BB than premixed regimens and lower in patients aged < 65 years.

conclusionGreater HbA1c reductions, but a higher incidence of hypoglycaemia, were reported with BB versus premixed regimens, while both cohorts demonstrated clinically meaningful reductions in HbA1c during follow-up. After initiation, most premixed regimens remained unchanged, whereas switches from BB to less intensive regimens were numerous, in accordance with the use of BB for a limited duration to improve FPG and PPG control.

Indexed as

Basal-bolus insulin therapyInsulin therapy initiationJapanese people with type 2 diabetesPremixed insulin therapyReal-world study

Identifiers

PMID33730337
PMCPMC8099980
OpenAlexW3139441619

What OpenQuestion holds

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LicenceCC BY-NC
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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.