Evidence map›Paper›PMID 28294488›Full record

Trial reportDiabetes, obesity & metabolism2017

Efficacy and safety of sitagliptin as compared with glimepiride in Japanese patients with type 2 diabetes mellitus aged ≥ 60 years (START-J trial).

Yasuo Terauchi, Yuichiro Yamada, Hitoshi Ishida, Mitsuru Ohsugi, Masafumi Kitaoka, Jo Satoh, Daisuke Yabe, Nobuyuki Shihara, Yutaka Seino

Abstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 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.

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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Observational
  8. Observational
  9. Article
  10. Article
  11. 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

9 authors.

Yasuo TerauchiJapan Association for Diabetes Education and Care, Tokyo, Japan.
Yuichiro YamadaJapan Association for Diabetes Education and Care, Tokyo, Japan.
Hitoshi IshidaJapan Association for Diabetes Education and Care, Tokyo, Japan.
Mitsuru OhsugiJapan Association for Diabetes Education and Care, Tokyo, Japan.
Masafumi KitaokaJapan Association for Diabetes Education and Care, Tokyo, Japan.
Jo SatohJapan Association for Diabetes Education and Care, Tokyo, Japan.
Daisuke YabeJapan Association for Diabetes Education and Care, Tokyo, Japan.
Nobuyuki ShiharaJapan Association for Diabetes Education and Care, Tokyo, Japan.ORCID 0000-0002-9422-5360
Yutaka SeinoJapan Association for Diabetes Education and Care, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to evaluate the efficacy and safety of sitagliptin administered to elderly patients with type 2 diabetes mellitus (T2DM) for 1 year as compared with glimepiride. Patients aged ≥60 years with T2DM and inadequately controlled blood glucose were randomly assigned to sitagliptin 50 mg once daily or glimepiride 0.5 mg once daily for 52 weeks. The primary efficacy endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 52. Secondary efficacy endpoints included self-monitored blood glucose and weight. Safety endpoints were adverse events including hypoglycaemia. Administration of sitagliptin or glimepiride to elderly patients with T2DM resulted in a significant decrease in HbA1c change from baseline. At 52 weeks, the least squares mean difference between the treatments was 0.11% (95% confidence interval [CI] -0.02 to 0.24; P = .087) (1.2 mmol/mol [-0.2 to 2.6]). The upper limit of the CI was below the predefined non-inferiority margin (0.3% [3.3 mmol/mol]), demonstrating non-inferiority of sitagliptin to glimepiride for the primary endpoint. Sitagliptin resulted in a significantly lower incidence rate of non-serious hypoglycaemia than glimepiride during the 52 weeks (4.7% vs 16.1%; P = .002); thus, sitagliptin is a useful therapeutic option for elderly patients with T2DM.

Indexed as

AgingActivities of Daily LivingAgedAged, 80 and overBlood Glucose Self-MonitoringDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsEquivalence Trials as TopicGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsIncidenceIncretinsJapanDipeptidyl-Peptidase IV InhibitorsglimepirideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsIncretinsSitagliptin PhosphateSulfonylurea Compoundsclinical trialDPP-4 inhibitorrandomized trialsitagliptinsulphonylureas

Identifiers

PMID28294488
PMCPMC5573934

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.