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Type 2 DiabetesUTI-flogNCT04735042

SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.

An observational study of Type 2 Diabetes and Urinary Tract Infections, run by University of Pisa at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this observational study, 60 subjects with type 2 diabetes (T2D) and eligible, as per good clinical practice, for therapy with SGLT-2 inhibitor, will be randomized to receive a SGLT-2 inhibitor or a fixed dose combination of SGLT-2 inhibitor with a DPP4-inihibitor for 12 weeks. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes, Urinary Tract Infections
What is being tested?
Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill and Empagliflozin or Dapagliflozin Pill
Type of treatment
Pill or oral medicine
How many people
60 participants
Where
1 siteItaly
Study dates
7 Oct 2020to 7 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will consecutively enrolled 60 patients among those referring to the Departiment of Diabetes and Metabolic disease, Santa Chiara Hospital, Pisa.

Who may be able to join

  • Type 2 diabetes diagnosis
  • Hb1Ac ≥ 7% and ≤ 9%

Who cannot join

  • Hb1Ac > 9%
  • 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).

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University of Pisa

    Pisa, Pisa, 56125

Other trials in Italy

About this study

Official title: Use of Combination Empagliflozin/Linagliptin or Dapagliflozin/Saxagliptin vs Empagliflozin or Dapagliflozin Alone, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.

In this observational study, 60 subjects with type 2 diabetes (T2D) and eligible, as per good clinical practice, for therapy with SGLT-2 inhibitor, will be randomized to receive a SGLT-2 inhibitor or a fixed dose combination of SGLT-2 inhibitor with a DPP4-inihibitor for 12 weeks. Measures will be performed at baseline and after 12 weeks of treatment, as per good clinical practice.

Read the detailed description

The day of the study patients undergo a routine clinical evaluation. Whole blood samples will be collected from an antecubital vein to assess serum/plasma aliquots of 200 μl each (frozen at -80°C until required for quantitation) for evaluation of biochemical parameters (fasting glucose, HbA1c, lipid profile, serum creatinine, uric acid, electrolytes, liver function enzymes, albumin).

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.

Being tested
Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill, Empagliflozin or Dapagliflozin Pill
Keywords
UTI, Type 2 Diabetes, SGLT2 inhibitors, DPP4 inhibitors
Medical subject headings
Diabetes Mellitus, Type 2, Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin PillDrug

    Also called Glyxambi or Qtern

    association between SGLT2-inhibitor and DPP4-inhibitor

  • Empagliflozin or Dapagliflozin PillDrug

    Also called Jardiance or Forxiga

    SGLT2-inhibitor: diabetic oral drug with diuretic properties.

Study groups in NCT04735042
Study groupRoleWhat they receive
SGLT2 and DPP-4 inhibitorsPatients undergoing SGLT2i and DPP4i.
Receives: Drug: Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill
SGLT2 inhibitors onlyPatients undergoing SGLT2i alone.
Receives: Drug: Empagliflozin or Dapagliflozin Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in metagenomic analysis based on rRNA 16S gene

    Metagenomic analysis based on rRNA 16S gene will be performed by Novogene on Illumina platform (Hong Kong, China)

    Measured: Each patients will be analyzed at baseline and after 12 weeks

  2. Change from Baseline of total bacterial load

    Absolute quantification of total bacterial load in the original sample using real-Time quantitative PCR

    Measured: Each patients will be analyzed at baseline and after 12 weeks

Secondary outcomes (7)

  1. Fasting glucose

    Fasting glucose measured in a fasting morning blood sample

    Measured: baseline and 12 week

  2. Glycated Haemoglobin

    HbA1c in a fasting measured in a morning blood sample

    Measured: baseline and 12 week

  3. Renal function

    Using creatinine measured in a fasting morning blood sample and estimated by eGFR (calculated with the CDK-EPI formula)

    Measured: baseline and 12 week

  4. Albumin excretion

    Measured by urinary albumin/creatinine ratio

    Measured: baseline and 12 week

  5. Total cholesterol

    Total cholesterol measured in a fasting morning blood sample

    Measured: baseline and 12 week

  6. HDL cholesterol

    HDL cholesterol measured in a fasting morning blood sample

    Measured: baseline and 12 week

  7. Triglycerides

    Triglycerides measured in a fasting morning blood sample

    Measured: baseline and 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2021
  2. Study start7 Oct 2020
  3. Primary completion7 Oct 2021
  4. Study completion7 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04735042
Sponsor's protocol ID
AS0005
Acronym
UTI-flog
Status last verified
Jul 2025
First submitted
22 Jan 2021
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25759592

  • 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.

    PubMed 20937688

  • 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.

    PubMed 20539810

  • 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.

    PubMed 29520146

  • 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.

    PubMed 24567764

  • 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.

    PubMed 28622967

  • 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.

    PubMed 28588220

  • 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.

    PubMed 27862830

  • 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.

    PubMed 28769579

  • 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.

    PubMed 29446523

  • 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.

    PubMed 25140306

  • 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.

    PubMed 23967406

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes and Urinary Tract Infections, run by University of Pisa at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in metagenomic analysis based on rRNA 16S gene (time frame: Each patients will be analyzed at baseline and after 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04735042, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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