PMID- 33669354
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240331
IS  - 2079-7737 (Print)
IS  - 2079-7737 (Electronic)
IS  - 2079-7737 (Linking)
VI  - 10
IP  - 2
DP  - 2021 Feb 16
TI  - Assessing Scientific Soundness and Translational Value of Animal Studies on DPP4 
      Inhibitors for Treating Type 2 Diabetes Mellitus.
LID - 10.3390/biology10020155 [doi]
LID - 155
AB  - Although there is a wide range of animal models of type 2 diabetes mellitus 
      (T2DM) used in research; we have limited evidence on their translation value. 
      This paper provides a) a comparison of preclinical animal and clinical results on 
      the effect of five dipeptidyl peptidase-4 (DPP4) inhibitors by comparing the 
      pharmaceutical caused glucose changes, and b) an evaluation of methodological and 
      reporting standards in T2DM preclinical animal studies. DPP4 inhibitors play an 
      important role in the clinical management of T2DM: if metformin alone is not 
      sufficient enough to control the blood sugar levels, DPP4 inhibitors are often 
      used as second-line therapy; additionally, DPP-4 inhibitors are also used in 
      triple therapies with metformin and sodium-glucose co-transporter-2 (SGLT-2) 
      inhibitors or with metformin and insulin. In our analysis of 124 preclinical 
      studies and 47 clinical trials, (1) we found no evidence of species differences 
      in glucose change response to DPP4 inhibitors, which may suggest that, for this 
      drug class, studies in mice and rats may be equally predictive of how well a drug 
      will work in humans; and (2) there is good reporting of group size, sex, age, 
      euthanasia method and self-reported compliance with animal welfare regulations in 
      animal studies but poor reporting of justification of group size, along with a 
      strong bias towards the use of male animals and young animals. Instead of the 
      common non-transparent model selection, we call for a reflective and 
      evidenced-based assessment of predictive validity of the animal models currently 
      available.
FAU - Franco, Nuno Henrique
AU  - Franco NH
AUID- ORCID: 0000-0003-4015-0532
AD  - Laboratory Animal Science Group, IBMC-Instituto de Biologia Molecular e Celular, 
      Universidade do Porto, Rua Alfredo Allen 208, 4200-135 Porto, Portugal.
AD  - Instituto de Investigacao e Inovacao da Universidade do Porto, Rua Alfredo Allen 
      208, 4200-135 Porto, Portugal.
FAU - Miranda, Sonia Batista
AU  - Miranda SB
AUID- ORCID: 0000-0002-7973-8264
AD  - Laboratory Animal Science Group, IBMC-Instituto de Biologia Molecular e Celular, 
      Universidade do Porto, Rua Alfredo Allen 208, 4200-135 Porto, Portugal.
AD  - Instituto de Investigacao e Inovacao da Universidade do Porto, Rua Alfredo Allen 
      208, 4200-135 Porto, Portugal.
FAU - Kovacs, Nora
AU  - Kovacs N
AD  - Department of Public Health and Epidemiology, Faculty of Medicine, University of 
      Debrecen, Kassai ut 26, 4028 Debrecen, Hungary.
FAU - Nagy, Attila
AU  - Nagy A
AD  - Faculty of Public Health, University of Debrecen, Kassai ut 26, 4028 Debrecen, 
      Hungary.
FAU - Thien, Bui Quoc
AU  - Thien BQ
AD  - Faculty of Medicine, University of Debrecen, Egyetem Square 1, 4032 Debrecen, 
      Hungary.
FAU - Reis, Flavio
AU  - Reis F
AUID- ORCID: 0000-0003-3401-9554
AD  - Institute of Pharmacology and Experimental Therapeutics, and Coimbra Institute 
      for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of 
      Coimbra, 3000-548 Coimbra, Portugal.
AD  - Center for Innovative Biomedicine and Biotechnology (CIBB), University of 
      Coimbra, 3004-504 Coimbra, Portugal.
AD  - Clinical Academic Center of Coimbra (CACC), 3004-504 Coimbra, Portugal.
FAU - Varga, Orsolya
AU  - Varga O
AD  - Department of Public Health and Epidemiology, Faculty of Medicine, University of 
      Debrecen, Kassai ut 26, 4028 Debrecen, Hungary.
AD  - Office for Research Groups Attached to Universities and Other Institutions, 
      Hungarian Academy of Sciences, 1051 Budapest, Hungary.
LA  - eng
PT  - Journal Article
DEP - 20210216
PL  - Switzerland
TA  - Biology (Basel)
JT  - Biology
JID - 101587988
PMC - PMC7920304
OTO - NOTNLM
OT  - animal models
OT  - predictive validity
OT  - research bias
OT  - translational medicine
OT  - type 2 diabetes mellitus
COIS- The authors declare no conflict of interest. The funders had no role in the 
      design of the study; in the collection, analyses, or interpretation of data; in 
      the writing of the manuscript, or in the decision to publish the results.
EDAT- 2021/03/07 06:00
MHDA- 2021/03/07 06:01
PMCR- 2021/02/16
CRDT- 2021/03/06 01:04
PHST- 2021/01/14 00:00 [received]
PHST- 2021/02/10 00:00 [revised]
PHST- 2021/02/13 00:00 [accepted]
PHST- 2021/03/06 01:04 [entrez]
PHST- 2021/03/07 06:00 [pubmed]
PHST- 2021/03/07 06:01 [medline]
PHST- 2021/02/16 00:00 [pmc-release]
AID - biology10020155 [pii]
AID - biology-10-00155 [pii]
AID - 10.3390/biology10020155 [doi]
PST - epublish
SO  - Biology (Basel). 2021 Feb 16;10(2):155. doi: 10.3390/biology10020155.