Evidence map›Paper›PMID 26749529›Full record

Trial reportDiabetes, obesity & metabolism2016

Efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus: a 24-week multicentre, randomized, double-blind, placebo-controlled phase III trial.

S Hong, C-Y Park, K A Han, C H Chung, B J Ku, H C Jang, C W Ahn, M-K Lee, M K Moon, H S Son and 3 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 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

16 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Efficacy and safety of teneligliptin.Indian journal of endocrinology and metabolism
    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

13 authors.

S HongDepartment of Internal Medicine, College of Medicine, Hanyang University, Seoul, Korea.
C-Y ParkDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
K A HanDepartment of Internal Medicine, Eulji University College of Medicine, Seoul, Korea.
C H ChungDepartment of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
B J KuDivision of Endocrinology, Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
H C JangDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
C W AhnDepartment of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
M-K LeeSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
M K MoonDepartment of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
H S SonDepartment of Internal Medicine, Uijeognbu St. Mary's Hospital, Catholic University Medical College, Uijeongbu, Korea.
C B LeeDepartment of Internal Medicine, College of Medicine, Hanyang University, Seoul, Korea.
Y-W ChoDepartment of Internal Medicine, CHA Bungdang Medical Center, CHA University College of Medicine, Seongnam, Korea.
S-W ParkDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We assessed the 24-week efficacy and safety of teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Korean patients with type 2 diabetes mellitus (T2DM) that was inadequately controlled with diet and exercise. The present study was designed as a multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study. Patients (n = 142) were randomized 2 : 1 into two different treatment groups as follows: 99 received teneligliptin (20 mg) and 43 received placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Teneligliptin significantly reduced the HbA1c level from baseline compared with placebo after 24 weeks. At week 24, the differences between changes in HbA1c and fasting plasma glucose (FBG) in the teneligliptin and placebo groups were -0.94% [least-squares (LS) mean -1.22, -0.65] and -1.21 mmol/l (-1.72, -0.70), respectively (all p < 0.001). The incidence of hypoglycaemia and adverse events were not significantly different between the two groups. This phase III, randomized, placebo-controlled study provides evidence of the safety and efficacy of 24 weeks of treatment with teneligliptin as a monotherapy in Korean patients with T2DM.

Indexed as

Insulin ResistanceAdministration, OralBlood GlucoseCombined Modality TherapyDiabetes Mellitus, Type 2Diet, DiabeticDipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodExerciseGlycated HemoglobinHumansHyperglycemiaHypoglycemiaIncidencePatient CompliancePyrazoles3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidineBlood GlucoseDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanPyrazolesThiazolidinesantidiabetic drugDPP-IV inhibitorphase III studytype 2 diabetes

Identifiers

PMID26749529
PMCPMC5069603

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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.