Evidence map›Paper›PMID 25816296›Full record

Trial reportPloS one2015

Efficacy and safety of sitagliptin added to insulin in Japanese patients with type 2 diabetes: the EDIT randomized trial.

Seiji Sato, Yoshifumi Saisho, Kinsei Kou, Shu Meguro, Masami Tanaka, Junichiro Irie, Toshihide Kawai, Hiroshi Itoh

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

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
4.5field-weighted citation impact, top 5% 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

21 citing papers in PubMed, 27 citations in OpenAlex.

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  9. Safety and Efficacy of DPP4 Inhibitor and Basal Insulin in Type 2 Diabetes: An Updated Review and Challenging Clinical Scenarios.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018
    Review
  10. Article
  11. Use of Diabetes Treatment Satisfaction Questionnaire in Diabetes Care: Importance of Patient-Reported Outcomes.International journal of environmental research and public health · 2018 · on this map
    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

8 authors at 1 institution in 1 country.

Seiji SatoDepartment of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Yoshifumi SaishoDepartment of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Kinsei KouDepartment of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Shu MeguroDepartment of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Masami TanakaDepartment of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Junichiro IrieDepartment of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Toshihide KawaiDepartment of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Hiroshi ItohDepartment of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Keio University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo clarify the efficacy and safety of adding sitagliptin to insulin therapy in Japanese patients with suboptimally controlled type 2 diabetes (T2DM). STUDY DESIGN AND

methodsThis was a 24-week, prospective, randomized, open-labeled, controlled trial. Patients with T2DM who were suboptimally controlled despite receiving at least twice daily injection of insulin were enrolled in the study. The patients were randomized to continuation of insulin treatment (Insulin group) or addition of sitagliptin 50 to 100 mg daily to insulin treatment (Ins+Sita group). The primary outcome was change in HbA1c at week 24.

resultsAdding sitagliptin to insulin significantly reduced HbA1c from 7.9 ± 1.0% at baseline to 7.0 ± 0.8% at week 24 (P <0.0001), while there was no significant change in HbA1c in the Insulin group (7.8 ± 0.7% vs. 7.8 ± 1.1%, P = 0.32). The difference in HbA1c reduction between the groups was 0.9% (95% confidence interval, 0.4 to 1.5, P = 0.01). There was no significant weight gain in either group. Incidence of hypoglycemia was significantly reduced in the Ins+Sita group compared with the Insulin group. Treatment satisfaction was improved in the Ins+Sita group. Baseline HbA1c level and beta cell function were associated with the magnitude of reduction in HbA1c in the Ins+Sita group.

conclusionAdding sitagliptin to insulin reduced HbA1c without weight gain or increase in hypoglycemia, and improved treatment satisfaction in Japanese patients with T2DM who were suboptimally controlled despite at least twice daily injection of insulin.

trial registrationThe University Hospital Medical Information Network (UMIN) Clinical Trials Registry UMIN000004678.

Indexed as

AgedDiabetes Mellitus, Type 2Drug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulinJapanMaleMiddle AgedPatient SatisfactionProspective StudiesSitagliptin PhosphateTreatment OutcomeGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinSitagliptin Phosphate

Identifiers

PMID25816296
PMCPMC4376939
OpenAlexW2032807852

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.