Type 1 DiabetesPhase 2/3SITA-oneNCT05219409
Effects of Sitagliptin in Relatives of T1D Patients
A Phase 2/3 study testing Sitagliptin and Professional CGM in people with Type 1 Diabetes, run by University of Milan at 1 site in Italy.
Trial summary
Type 1 Diabetes (T1D) is a chronic autoimmune disease, with a genetic background, resulting from the immune-mediated destruction of beta cells of the pancreas. It can lead to fatal short-term and long-term complications, especially if it is diagnosed late. Read more about this study
- Who is it for?
- Ages 10 to 45 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sitagliptin and Professional CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2023to Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 10 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age of the subject between 10 and 45 years
- Subject (or legal guardian in the case of a minor) is able to provide informed consent
- If a first degree relative of the proband with T1D must be between 6 and 45 years old (brother, sister, parent, child)
- If a relative of the proband with T1D is second degree, he must be between 6 and 20 years old (nephew, uncle, aunt, grandfather, grandmother, cousin)
- Presence of at least two autoantibodies associated with diabetes
- Impaired glucose tolerance on the OGTT test (fasting glucose greater than 110 mg/dl but less than 126 mg/dl or 2-hour glucose greater than or equal to 140 mg/dl but less than 200 mg/dl or 'OGTT at 30', 60 ', 90' greater than or equal to 200 mg/dl)
Show all 11Show fewer
- If the subject is a female with reproductive potential, she must have a negative pregnancy test at the enrollment visit and must agree not to seek pregnancy for at least one year from randomization
- If the subject is male, he must agree not to seek pregnancies with any partner for at least one year from the randomization
- The subject must agree to renounce other types of trials during this study
- Weight at the time of recruitment of at least 26 kg
- It must be favorable and clinically acceptable to postpone vaccinations with live and attenuated agents for at least one year after treatment
Who cannot join
- Type 1 Diabetes Mellitus previously diagnosed or diagnosed during screening investigations
- Serological evidence of current or past HIV, Hepatitis C, Hepatitis B
- Changes in blood counts, INR or liver enzymes
- Being pregnant or breastfeeding
- Evidence of pancreatic changes in the laboratory
- Having undergone a previous experimental treatment for Type 1 Diabetes Mellitus
Show all 31Show fewer
- Chronic Renal Failure stage IIIa onwards (eGFR <45 ml / min / 1.7 m2)
- History of previous pancreatitis
- Lymphopenia (<1000 lymphocytes / µL)
- Neutropenia (<1500 PMN / µL)
- Thrombocytopenia (<150,000 platelets / µL)
- Anemia (Hgb <10 grams / deciliter [g / dL])
- AST or ALT> 1.5 x ULN
- Total bilirubin> 1.5 x upper limit of normal (ULN) with the exception of subjects diagnosed with Gilbert's syndrome who may be eligible provided they have no other cause leading to hyperbilirubinemia
- INR> 0.1 above the upper limit of the norm at the laboratory of the participating center
- Alterations of Amylase and Lipase due to the pancreas
- Chronic active infection other than localized skin infections
- A positive PPD test
- Vaccination with a live virus within 8 weeks of randomization
- Vaccination with a killed virus within 4 weeks of randomization
- Laboratory or clinical evidence of acute EBV or CMV infection
- Serological evidence of current or past HIV, hepatitis B or hepatitis C infection
- Being currently pregnant or breastfeeding, or planning to become pregnant
- Chronic use of steroids or other immunosuppressive agents
- A history of asthma or atopic disease that requires chronic treatment
- Untreated hypothyroidism or active Graves' disease at randomization
- Current use of non-insulin drugs that affect glycemic control
- Previous OKT®3 or other anti-CD3 treatment
- Administration of a monoclonal antibody within the year prior to randomization
- Participation in any type of clinical trial of therapeutic drugs or vaccines in the 12 weeks prior to randomization
- Any conditions that, in the opinion of the investigator, could interfere with the conduct of the study or with the safety of the subject.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Sitagliptin in Relatives of Patients With Type 1 Diabetes Mellitus, at High Risk of Developing the Disease
Type 1 Diabetes (T1D) is a chronic autoimmune disease, with a genetic background, resulting from the immune-mediated destruction of beta cells of the pancreas. It can lead to fatal short-term and long-term complications, especially if it is diagnosed late. Three stages of the disease can be identified: Stage 1 is defined by the presence of two or more anti-islet autoantibodies (GAD65, ICA, IA-2, ZnT8) with normoglycemia, Stage 2 shows progression to dysglycemia (impaired glucose tolerance) in the setting of two or more anti-islet autoantibodies, Stage 3 occurs when a patient meets ADA criteria for the diagnosis of diabetes. It's been demonstrated that Teplizumab (an Fc receptor nonbinding anti-CD3 monoclonal antibody) delays the transition from pre-symptomatic T1D (stage 2) to overt T1D (stage 3). Also Sitagliptin, a DPP4 inhibitor, has been proved effective in inhibiting inflammation in T1D both in vitro in T1D mice, and in vivo in Latent autoimmune diabetes in adults (LADA) patients. Furthermore, it has been confirmed that Sitagliptin reduces the prevalence of worse forms of acute GVHD after myeloablative allogeneic hematopoietic stem-cell transplantation.
The study aims to investigate if Sitagliptin can have a delaying effect on progression to overt T1D, on the account of its anti-inflammatory properties. The cohort is made of screened relatives of T1D patients, who are classified as high-risk of developing T1D.
Screening relatives of T1D patients for dysglycemia and anti-islet autoantibodies. Selecting the patients in Stage 2 Pre-symptomatic T1D (dysglycemia and at least two types of autoantibodies) and then beginning therapy with Sitagliptin, while monitoring their glucose metabolism with a Continuous Glucose Monitoring (CGM) system.
- Conditions
- Type 1 Diabetes
- Being tested
- Sitagliptin, Professional CGM
- Keywords
- Sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
The dose of sitagliptin will be established on the basis of the estimated glomerular filtrate: 100 mg in single daily administration (estimated glomerular filtration rate less than or equal to 45 mL / min / 1.73 m2) or 50 mg (estimated glomerular filtration rate 30-45 mL / min / 1.73 m2)
Professional CGMDevice
The sensor records the patient's glucose readings every 15 minutes for up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Sitagliptin Receives: Drug: Sitagliptin; Device: Professional CGM |
| Control group | Placebo comparator | Placebo Receives: Device: Professional CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of new diagnoses of Type 1 Diabetes Mellitus per year
Measured: 3 years
Secondary outcomes (1)
Number of participants with adverse effects on Sitagliptin
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study startJul 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled open label intervention study is proposed. Relatives of patients with type 1 diabetes in stage 2 will be included in the study and divided into two groups by randomization: sitagliptin add-on therapy vs placebo(group of control)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Fiorina, MD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219409
- Sponsor's protocol ID
- 01/2022
- Acronym
- SITA-one
- Status last verified
- May 2023
- First submitted
- 20 Jan 2022
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Variation and trends in incidence of childhood diabetes in Europe. EURODIAB ACE Study Group. Lancet. 2000 Mar 11;355(9207):873-6.
PubMed 10752702Eisenbarth GS. Type I diabetes mellitus. A chronic autoimmune disease. N Engl J Med. 1986 May 22;314(21):1360-8. doi: 10.1056/NEJM198605223142106. No abstract available.
PubMed 3517648Ziegler AG, Rewers M, Simell O, Simell T, Lempainen J, Steck A, Winkler C, Ilonen J, Veijola R, Knip M, Bonifacio E, Eisenbarth GS. Seroconversion to multiple islet autoantibodies and risk of progression to diabetes in children. JAMA. 2013 Jun 19;309(23):2473-9. doi: 10.1001/jama.2013.6285.
PubMed 23780460Dabelea D, Pihoker C, Talton JW, D'Agostino RB Jr, Fujimoto W, Klingensmith GJ, Lawrence JM, Linder B, Marcovina SM, Mayer-Davis EJ, Imperatore G, Dolan LM; SEARCH for Diabetes in Youth Study. Etiological approach to characterization of diabetes type: the SEARCH for Diabetes in Youth Study. Diabetes Care. 2011 Jul;34(7):1628-33. doi: 10.2337/dc10-2324. Epub 2011 Jun 2.
PubMed 21636800Insel RA, Dunne JL, Atkinson MA, Chiang JL, Dabelea D, Gottlieb PA, Greenbaum CJ, Herold KC, Krischer JP, Lernmark A, Ratner RE, Rewers MJ, Schatz DA, Skyler JS, Sosenko JM, Ziegler AG. Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care. 2015 Oct;38(10):1964-74. doi: 10.2337/dc15-1419.
PubMed 26404926Sosenko JM, Skyler JS, Mahon J, Krischer JP, Greenbaum CJ, Rafkin LE, Beam CA, Boulware DC, Matheson D, Cuthbertson D, Herold KC, Eisenbarth G, Palmer JP; Type 1 Diabetes TrialNet and Diabetes Prevention Trial-Type 1 Study Groups. Use of the Diabetes Prevention Trial-Type 1 Risk Score (DPTRS) for improving the accuracy of the risk classification of type 1 diabetes. Diabetes Care. 2014 Apr;37(4):979-84. doi: 10.2337/dc13-2359. Epub 2014 Feb 18.
PubMed 24550217Herold KC, Bundy BN, Long SA, Bluestone JA, DiMeglio LA, Dufort MJ, Gitelman SE, Gottlieb PA, Krischer JP, Linsley PS, Marks JB, Moore W, Moran A, Rodriguez H, Russell WE, Schatz D, Skyler JS, Tsalikian E, Wherrett DK, Ziegler AG, Greenbaum CJ; Type 1 Diabetes TrialNet Study Group. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. N Engl J Med. 2019 Aug 15;381(7):603-613. doi: 10.1056/NEJMoa1902226. Epub 2019 Jun 9.
PubMed 31180194Malvandi AM, Loretelli C, Ben Nasr M, Zuccotti GV, Fiorina P. Sitagliptin favorably modulates immune-relevant pathways in human beta cells. Pharmacol Res. 2019 Oct;148:104405. doi: 10.1016/j.phrs.2019.104405. Epub 2019 Aug 20.
PubMed 31442575Hu X, Liu S, Liu X, Zhang J, Liang Y, Li Y. DPP-4 (CD26) inhibitor sitagliptin exerts anti-inflammatory effects on rat insulinoma (RINm) cells via suppressing NF-kappaB activation. Endocrine. 2017 Mar;55(3):754-763. doi: 10.1007/s12020-016-1073-8. Epub 2016 Sep 9.
PubMed 27612849Ujhelyi J, Ujhelyi Z, Szalai A, Laszlo JF, Cayasso M, Vecsernyes M, Porszasz R. Analgesic and anti-inflammatory effectiveness of sitagliptin and vildagliptin in mice. Regul Pept. 2014 Nov;194-195:23-9. doi: 10.1016/j.regpep.2014.09.006. Epub 2014 Sep 16.
PubMed 25229125Matteucci E, Giampietro O. Dipeptidyl peptidase-4 (CD26): knowing the function before inhibiting the enzyme. Curr Med Chem. 2009;16(23):2943-51. doi: 10.2174/092986709788803114.
PubMed 19689275Jelsing J, Vrang N, van Witteloostuijn SB, Mark M, Klein T. The DPP4 inhibitor linagliptin delays the onset of diabetes and preserves beta-cell mass in non-obese diabetic mice. J Endocrinol. 2012 Sep;214(3):381-7. doi: 10.1530/JOE-11-0479. Epub 2012 Jul 3.
PubMed 22761275Kim SJ, Nian C, Doudet DJ, McIntosh CH. Dipeptidyl peptidase IV inhibition with MK0431 improves islet graft survival in diabetic NOD mice partially via T-cell modulation. Diabetes. 2009 Mar;58(3):641-51. doi: 10.2337/db08-1101. Epub 2008 Dec 10.
PubMed 19073764Davanso MR, Caliari-Oliveira C, Couri CEB, Covas DT, de Oliveira Leal AM, Voltarelli JC, Malmegrim KCR, Yaochite JNU. DPP-4 Inhibition Leads to Decreased Pancreatic Inflammatory Profile and Increased Frequency of Regulatory T Cells in Experimental Type 1 Diabetes. Inflammation. 2019 Apr;42(2):449-462. doi: 10.1007/s10753-018-00954-3.
PubMed 30707388Zhao Y, Yang L, Xiang Y, Liu L, Huang G, Long Z, Li X, Leslie RD, Wang X, Zhou Z. Dipeptidyl peptidase 4 inhibitor sitagliptin maintains beta-cell function in patients with recent-onset latent autoimmune diabetes in adults: one year prospective study. J Clin Endocrinol Metab. 2014 May;99(5):E876-80. doi: 10.1210/jc.2013-3633. Epub 2014 Jan 16.
PubMed 24432999
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sitagliptin in Relatives of Patients With Type 1 Diabetes Mellitus, at High Risk of Developing the Disease
- ClinicalTrials.gov ID
- NCT05219409
- Acronym / sponsor ID
- SITA-one / 01/2022
- Conditions
- Type 1 Diabetes
- Keywords
- Sitagliptin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 1 Diabetes (T1D) is a chronic autoimmune disease, with a genetic background, resulting from the immune-mediated destruction of beta cells of the pancreas. It can lead to fatal short-term and long-term complications, especially if it is diagnosed late. Three stages of the disease can be identified: Stage 1 is defined by the presence of two or more anti-islet autoantibodies (GAD65, ICA, IA-2, ZnT8) with normoglycemia, Stage 2 shows progression to dysglycemia (impaired glucose tolerance) in the setting of two or more anti-islet autoantibodies, Stage 3 occurs when a patient meets ADA criteria for the diagnosis of diabetes. It's been demonstrated that Teplizumab (an Fc receptor nonbinding anti-CD3 monoclonal antibody) delays the transition from pre-symptomatic T1D (stage 2) to overt T1D (stage 3). Also Sitagliptin, a DPP4 inhibitor, has been proved effective in inhibiting inflammation in T1D both in vitro in T1D mice, and in vivo in Latent autoimmune diabetes in adults (LADA) patients. Furthermore, it has been confirmed that Sitagliptin reduces the prevalence of worse forms of acute GVHD after myeloablative allogeneic hematopoietic stem-cell transplantation.
The study aims to investigate if Sitagliptin can have a delaying effect on progression to overt T1D, on the account of its anti-inflammatory properties. The cohort is made of screened relatives of T1D patients, who are classified as high-risk of developing T1D.
Screening relatives of T1D patients for dysglycemia and anti-islet autoantibodies. Selecting the patients in Stage 2 Pre-symptomatic T1D (dysglycemia and at least two types of autoantibodies) and then beginning therapy with Sitagliptin, while monitoring their glucose metabolism with a Continuous Glucose Monitoring (CGM) system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized controlled open label intervention study is proposed. Relatives of patients with type 1 diabetes in stage 2 will be included in the study and divided into two groups by randomization: sitagliptin add-on therapy vs placebo(group of control)
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: Sitagliptin, Device: Professional CGMSitagliptin |
| Control group | Placebo comparator | Device: Professional CGMPlacebo |
Who may qualify
- Ages
- 10 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Age of the subject between 10 and 45 years
- Subject (or legal guardian in the case of a minor) is able to provide informed consent
- If a first degree relative of the proband with T1D must be between 6 and 45 years old (brother, sister, parent, child)
- If a relative of the proband with T1D is second degree, he must be between 6 and 20 years old (nephew, uncle, aunt, grandfather, grandmother, cousin)
- Presence of at least two autoantibodies associated with diabetes
Key exclusion criteria (31 listed)
- Type 1 Diabetes Mellitus previously diagnosed or diagnosed during screening investigations
- Serological evidence of current or past HIV, Hepatitis C, Hepatitis B
- Changes in blood counts, INR or liver enzymes
- Being pregnant or breastfeeding
- Evidence of pancreatic changes in the laboratory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitagliptinThe dose of sitagliptin will be established on the basis of the estimated glomerular filtrate: 100 mg in single daily administration (estimated glomerular filtration rate less than or equal to 45 mL / min / 1.73 m2) or 50 mg (estimated glomerular filtration rate 30-45 mL / min / 1.73 m2) | Drug | Treatment group |
| Professional CGMThe sensor records the patient's glucose readings every 15 minutes for up to 14 days. | Device | Control group, Treatment group |
Primary outcome
Rate of new diagnoses of Type 1 Diabetes Mellitus per year
Time frame: 3 years
1 secondary outcome
Number of participants with adverse effects on Sitagliptin
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Results publication: PubMed 10752702Variation and trends in incidence of childhood diabetes in Europe. EURODIAB ACE Study Group. Lancet. 2000 Mar 11;355(9207):873-6.
- Results publication: PubMed 3517648Eisenbarth GS. Type I diabetes mellitus. A chronic autoimmune disease. N Engl J Med. 1986 May 22;314(21):1360-8. doi: 10.1056/NEJM198605223142106. No abstract available.
- Results publication: PubMed 23780460Ziegler AG, Rewers M, Simell O, Simell T, Lempainen J, Steck A, Winkler C, Ilonen J, Veijola R, Knip M, Bonifacio E, Eisenbarth GS. Seroconversion to multiple islet autoantibodies and risk of progression to diabetes in children. JAMA. 2013 Jun 19;309(23):2473-9. doi: 10.1001/jama.2013.6285.
- Results publication: PubMed 21636800Dabelea D, Pihoker C, Talton JW, D'Agostino RB Jr, Fujimoto W, Klingensmith GJ, Lawrence JM, Linder B, Marcovina SM, Mayer-Davis EJ, Imperatore G, Dolan LM; SEARCH for Diabetes in Youth Study. Etiological approach to characterization of diabetes type: the SEARCH for Diabetes in Youth Study. Diabetes Care. 2011 Jul;34(7):1628-33. doi: 10.2337/dc10-2324. Epub 2011 Jun 2.
- Results publication: PubMed 26404926Insel RA, Dunne JL, Atkinson MA, Chiang JL, Dabelea D, Gottlieb PA, Greenbaum CJ, Herold KC, Krischer JP, Lernmark A, Ratner RE, Rewers MJ, Schatz DA, Skyler JS, Sosenko JM, Ziegler AG. Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care. 2015 Oct;38(10):1964-74. doi: 10.2337/dc15-1419.
- Results publication: PubMed 24550217Sosenko JM, Skyler JS, Mahon J, Krischer JP, Greenbaum CJ, Rafkin LE, Beam CA, Boulware DC, Matheson D, Cuthbertson D, Herold KC, Eisenbarth G, Palmer JP; Type 1 Diabetes TrialNet and Diabetes Prevention Trial-Type 1 Study Groups. Use of the Diabetes Prevention Trial-Type 1 Risk Score (DPTRS) for improving the accuracy of the risk classification of type 1 diabetes. Diabetes Care. 2014 Apr;37(4):979-84. doi: 10.2337/dc13-2359. Epub 2014 Feb 18.
- Results publication: PubMed 31180194Herold KC, Bundy BN, Long SA, Bluestone JA, DiMeglio LA, Dufort MJ, Gitelman SE, Gottlieb PA, Krischer JP, Linsley PS, Marks JB, Moore W, Moran A, Rodriguez H, Russell WE, Schatz D, Skyler JS, Tsalikian E, Wherrett DK, Ziegler AG, Greenbaum CJ; Type 1 Diabetes TrialNet Study Group. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. N Engl J Med. 2019 Aug 15;381(7):603-613. doi: 10.1056/NEJMoa1902226. Epub 2019 Jun 9.
- Results publication: PubMed 31442575Malvandi AM, Loretelli C, Ben Nasr M, Zuccotti GV, Fiorina P. Sitagliptin favorably modulates immune-relevant pathways in human beta cells. Pharmacol Res. 2019 Oct;148:104405. doi: 10.1016/j.phrs.2019.104405. Epub 2019 Aug 20.
- Results publication: PubMed 27612849Hu X, Liu S, Liu X, Zhang J, Liang Y, Li Y. DPP-4 (CD26) inhibitor sitagliptin exerts anti-inflammatory effects on rat insulinoma (RINm) cells via suppressing NF-kappaB activation. Endocrine. 2017 Mar;55(3):754-763. doi: 10.1007/s12020-016-1073-8. Epub 2016 Sep 9.
- Results publication: PubMed 25229125Ujhelyi J, Ujhelyi Z, Szalai A, Laszlo JF, Cayasso M, Vecsernyes M, Porszasz R. Analgesic and anti-inflammatory effectiveness of sitagliptin and vildagliptin in mice. Regul Pept. 2014 Nov;194-195:23-9. doi: 10.1016/j.regpep.2014.09.006. Epub 2014 Sep 16.
- Results publication: PubMed 19689275Matteucci E, Giampietro O. Dipeptidyl peptidase-4 (CD26): knowing the function before inhibiting the enzyme. Curr Med Chem. 2009;16(23):2943-51. doi: 10.2174/092986709788803114.
- Results publication: PubMed 22761275Jelsing J, Vrang N, van Witteloostuijn SB, Mark M, Klein T. The DPP4 inhibitor linagliptin delays the onset of diabetes and preserves beta-cell mass in non-obese diabetic mice. J Endocrinol. 2012 Sep;214(3):381-7. doi: 10.1530/JOE-11-0479. Epub 2012 Jul 3.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sitagliptin and Professional CGM in people with Type 1 Diabetes, run by University of Milan 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 11 inclusion and 31 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: opening soon, as of the sponsor's last update on 10 May 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Rate of new diagnoses of Type 1 Diabetes Mellitus per year (time frame: 3 years). 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 NCT05219409, which also lists 16 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 10 May 2023.