Evidence map›Paper›PMID 30603311›Full record

ArticleDiabetology international2017

Insulin degludec in a simple or stepwise titration algorithm in a Japanese population of patients with type 2 diabetes: a randomized, 26-week, treat-to-target trial.

Takashi Kadowaki, Hideaki Jinnouchi, Kohei Kaku, Malene L Hersløv, Jacob Hyllested-Winge, Shuji Nakamura

Registry-linked trialAbstract read
In one paragraph

Article in Diabetology international, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01880736 (A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes), which is not on this 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
–field-weighted citation impact
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.

NCT01880736 phase3completednot on this map

A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes

TypeinterventionalSponsorNovo Nordisk A/SRan2013 to 2014Enrolled458ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec
3 · Its place in the literature

Who cites it

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

  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

6 authors.

Takashi Kadowaki1Department of Metabolic Diseases, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
Hideaki JinnouchiIryo Houjin Shadan Jinnouchikai, Jinnouchi Hospital, Kumamoto, Japan.
Kohei Kaku3Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan.
Malene L Hersløv4Medical and Science, Novo Nordisk A/S, Søborg, Denmark.
Jacob Hyllested-WingeMedical and Scientific Affairs, Novo Nordisk Pharma Ltd, Tokyo, Japan.
Shuji NakamuraIryo Houjin Shadan Kowakai, Heiwadai Hospital, Miyazaki, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsManaging insulin therapy is a challenge for both patients and healthcare providers.The primary aim of this trial was to compare the efficacy and safety of insulin degludec (IDeg) in a fixed versus flexible dosing schedule. The secondary aim and subject of this manuscript was to compare a simple versus a stepwise titration algorithm. MATERIALS AND

methodsThis was a 26-week, controlled, multicenter, open-label, randomized, treat-to-target phase 3b trial of Japanese patients with type 2 diabetes inadequately treated with insulin glargine and with/without antidiabetic drugs orally. The trial had a 2 × 2 factorial design whereby 458 patients were randomized 1:1:1:1 to one of two titration algorithms and one of two dosing schedules. IDeg dose was adjusted weekly using a clinician-led, treat-to-target approach in order to ensure optimal insulin titration and glycemic control following self-measured blood glucose (SMBG) readings.

resultsMean insulin dose at the end of the trial was similar in both simple and stepwise titration algorithms. Glycemic control improved in both titration algorithms, with noninferiority in glycated hemoglobin (HbA

conclusionsThis trial demonstrated comparable efficacy with noninferior HbA

Indexed as

Basal insulinInsulin degludecTitration algorithmType 2 diabetes

Identifiers

PMID30603311
PMCPMC6224933

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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.