Evidence map›Paper›PMID 31743602›Full record

Trial reportJournal of diabetes investigation2020

Factors associated with the glucose-lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials.

Naoko Tajima, Jun-Ichi Eiki, Taro Okamoto, Kotoba Okuyama, Masaru Kawashima, Samuel S Engel

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

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

2 citing papers in PubMed.

  1. Trial
  2. Article
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.

Naoko TajimaJikei University School of Medicine, Tokyo, Japan.
Jun-Ichi EikiMedical Affairs, and Japan Development, MSD K.K., Tokyo, Japan.ORCID https://orcid.org/0000-0002-1622-6114
Taro OkamotoMedical Affairs, and Japan Development, MSD K.K., Tokyo, Japan.
Kotoba OkuyamaMedical Affairs, and Japan Development, MSD K.K., Tokyo, Japan.
Masaru KawashimaMedical Affairs, ONO Pharmaceutical Co., Ltd., Osaka, Japan.
Samuel S EngelClinical Research, Merck & Co., Inc, Kenilworth, New Jersey, USA.

Funding

MerckMSD K.K.
6 · The paper itself

Abstract

AIMS/

introductionTo explore the factors associated with the glucose-lowering efficacy of sitagliptin treatment in Japanese patients with type 2 diabetes mellitus. MATERIALS AND

methodsThis was a post-hoc analysis of pooled data from seven sitagliptin phase II and III clinical studies carried out in Japan. All studies were double-blind, randomized, placebo-controlled, parallel-group and of 12-week duration. The analysis population consisted of 1,075 type 2 diabetes mellitus patients. In two of the trials, sitagliptin 50 mg and/or 100 mg daily were used as monotherapy; in five others, sitagliptin 50 mg daily was used as add-on treatment to ongoing pioglitazone, glimepiride, metformin, voglibose or glinides. Efficacy (reduction in hemoglobin A1c [HbA1c]) was evaluated in 12 sets of subgroups defined by demographic, glycemic, pancreatic β-cell function and insulin resistance parameters. An analysis of covariance model was used to evaluate the interaction between each parameter and efficacy.

resultsSitagliptin consistently provided a clinically meaningful reduction in HbA1c relative to placebo across all subgroups. Within subgroups, a greater absolute HbA1c reduction was associated with higher baseline HbA1c, fasting plasma glucose and 2-h post-meal glucose. Lower β-cell function, represented by homeostatic model assessment of β-cell function and insulinogenic index, was also associated with greater HbA1c reduction. In contrast, age, sex, body mass index, duration of type 2 diabetes mellitus and insulin resistance-related parameters did not interact with HbA1c changes.

conclusionsSitagliptin treatment was associated with clinically meaningful improvement in glycemic control in all subgroups of Japanese patients with type 2 diabetes mellitus that were evaluated. Higher baseline glycemic status and lower baseline β-cell function were identified as factors associated with greater HbA1c reduction after sitagliptin treatment.

Indexed as

AgedAsian PeopleDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleHumansHypoglycemic AgentsJapanMaleMiddle AgedSitagliptin PhosphateTreatment OutcomeHypoglycemic AgentsSitagliptin PhosphateDipeptidyl peptidase-4 inhibitorsIncretinsSitagliptin

Identifiers

PMID31743602
PMCPMC7232313

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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 Socratic graph.