SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.
NCT ID: NCT04735042
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
60 participants
OBSERVATIONAL
2020-10-07
2022-04-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Effectiveness of Dapagliflozin Versus DPP-4 Inhibitors
NCT04304430
Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients with Type 2 Diabetes
NCT04017221
A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes
NCT03817463
Effects of Dapagliflozin+Saxagliptin in Addition to Metformin v/s Saxagliptin or Dapagliflozin in Patients With DM2.
NCT03714594
To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients
NCT04445714
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A mid-stream first urine in the morning sample will be collected into a sterile container. 50 ml of urine will be immediately transferred into a sterile falcon and centrifugated at 4500 rpm for 10 min. After removal of the supernatant and addition of 10 ml of PBS or sterile physiological solution, the sample will be further centrifugated at 4500 rpm for 10 min. The supernatant will be removed and the pellet stored in a falcon at -80°C.
Genomic DNA will be extracted throw Qiamp DNA mini kit (QIAGEN) and quantified using spectrophotometric assay.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SGLT2 and DPP-4 inhibitors
Patients undergoing SGLT2i and DPP4i.
Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill
association between SGLT2-inhibitor and DPP4-inhibitor
SGLT2 inhibitors only
Patients undergoing SGLT2i alone.
Empagliflozin or Dapagliflozin Pill
SGLT2-inhibitor: diabetic oral drug with diuretic properties.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill
association between SGLT2-inhibitor and DPP4-inhibitor
Empagliflozin or Dapagliflozin Pill
SGLT2-inhibitor: diabetic oral drug with diuretic properties.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Hb1Ac ≥ 7% and ≤ 9%
Exclusion Criteria
* current treatment with an SGLT2i or a DPP4i drugs, or in the prior 4 week
* irritating and/or obstructive urinary or genital symptoms
* menstrual cycle for women
* current antibiotic treatment or in the prior 4 weeks
* anatomical or functional abnormalities of the urinary tract (e.g. incontinence, neurological bladder, bladder prolapse).
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pisa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anna Solini
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anna Solini, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pisa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pisa
Pisa, Pisa, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Del Prato S, Rosenstock J, Garcia-Sanchez R, Iqbal N, Hansen L, Johnsson E, Chen H, Mathieu C. Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin. Diabetes Obes Metab. 2018 Jun;20(6):1542-1546. doi: 10.1111/dom.13258. Epub 2018 Mar 25.
Kim NH, Yu T, Lee DH. The nonglycemic actions of dipeptidyl peptidase-4 inhibitors. Biomed Res Int. 2014;2014:368703. doi: 10.1155/2014/368703. Epub 2014 Jul 21.
Lewis DA, Brown R, Williams J, White P, Jacobson SK, Marchesi JR, Drake MJ. The human urinary microbiome; bacterial DNA in voided urine of asymptomatic adults. Front Cell Infect Microbiol. 2013 Aug 15;3:41. doi: 10.3389/fcimb.2013.00041. eCollection 2013.
Nitzan O, Elias M, Chazan B, Saliba W. Urinary tract infections in patients with type 2 diabetes mellitus: review of prevalence, diagnosis, and management. Diabetes Metab Syndr Obes. 2015 Feb 26;8:129-36. doi: 10.2147/DMSO.S51792. eCollection 2015.
Renko M, Tapanainen P, Tossavainen P, Pokka T, Uhari M. Meta-analysis of the significance of asymptomatic bacteriuria in diabetes. Diabetes Care. 2011 Jan;34(1):230-5. doi: 10.2337/dc10-0421. Epub 2010 Oct 11.
Schmiemann G, Kniehl E, Gebhardt K, Matejczyk MM, Hummers-Pradier E. The diagnosis of urinary tract infection: a systematic review. Dtsch Arztebl Int. 2010 May;107(21):361-7. doi: 10.3238/arztebl.2010.0361. Epub 2010 May 28.
He K, Hu Y, Shi JC, Zhu YQ, Mao XM. Prevalence, risk factors and microorganisms of urinary tract infections in patients with type 2 diabetes mellitus: a retrospective study in China. Ther Clin Risk Manag. 2018 Feb 26;14:403-408. doi: 10.2147/TCRM.S147078. eCollection 2018.
Aswani SM, Chandrashekar U, Shivashankara K, Pruthvi B. Clinical profile of urinary tract infections in diabetics and non-diabetics. Australas Med J. 2014 Jan 31;7(1):29-34. doi: 10.4066/AMJ.2014.1906. eCollection 2014.
Masajtis-Zagajewska A, Nowicki M. New markers of urinary tract infection. Clin Chim Acta. 2017 Aug;471:286-291. doi: 10.1016/j.cca.2017.06.003. Epub 2017 Jun 13.
Liu J, Li L, Li S, Jia P, Deng K, Chen W, Sun X. Effects of SGLT2 inhibitors on UTIs and genital infections in type 2 diabetes mellitus: a systematic review and meta-analysis. Sci Rep. 2017 Jun 6;7(1):2824. doi: 10.1038/s41598-017-02733-w.
Li D, Wang T, Shen S, Fang Z, Dong Y, Tang H. Urinary tract and genital infections in patients with type 2 diabetes treated with sodium-glucose co-transporter 2 inhibitors: A meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2017 Mar;19(3):348-355. doi: 10.1111/dom.12825. Epub 2016 Dec 19.
Yu H, Woo VC. Emerging use of combination therapies for the management of type 2 diabetes - focus on saxagliptin and dapagliflozin. Diabetes Metab Syndr Obes. 2017 Jul 21;10:317-332. doi: 10.2147/DMSO.S117982. eCollection 2017.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AS0005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.