T2DM (Type 2 Diabetes Mellitus)Sulfa-ZeroNCT04272359
Substitution of Sulfonylureas With New Generation of Hypoglycemic Drugs for the Treatment of Type 2 Diabetes Mellitus
An observational study of T2DM (Type 2 Diabetes Mellitus) and Diet, Healthy, run by University of Milan at 1 site in Italy.
Trial summary
This is a multicentric, prospective, parallel groups study. Patient recruitment will be carried out at the U.O. Departmental Endocrinology and Diabetology ASST FBF Sacco, Fatebenefratelli and Ophthalmic Hospital, and at the SSD of Endocrine Diseases and Diabetology ASST FBF Sacco, L. Sacco Hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus), Diet, Healthy, Renal Function Disorder
- What is being tested?
- Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas
- How many people
- 138 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2019to 31 Dec 2021
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The size of the sample chosen is such in consideration of the average number of patients suffering from type 2 Diabetes Mellitus treated by the Diabetology Clinics of the participating structures in the study and therefore will allow us to complete enrollment within the first months of the study
Who may be able to join
- Age over 18 years;
- 6.5% <HbA1c <11%;
- Diagnosis of type 2 diabetes mellitus;
- Active treatment with sulfonylureas / glinids, both in monotherapy and in association with other long-acting hypoglycemic / insulins.
- Written informed consent of the patient or a legal guardian signed and dated
Who cannot join
- Patients suffering from severe systemic diseases, fever, known chronic inflammatory states
- PCR determinants> 10 mg/L;
- HbA1c> 11% or HbA1c <6.5%;
- Use of corticosteroids at the time of enrollment;
- Poor patient understanding of spoken and written Italian;
- Absent compliance.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASST FBF-Sacco P.O. Sacco/Fatebenefratelli e Oftalmico
Milan, 20157
Teresa Letizia, letizia.teresa@asst-fbf-sacco.it
About this study
Official title: Prospective, Parallel Goups Study, Aimed to Evaluating Possible Benefits of the Treatment of New Generation Hypoglycaemic Drugs Compared to Sulphonylureas for the Tratment of Type 2 Diabetes Mellitus
This is a multicentric, prospective, parallel groups study. Patient recruitment will be carried out at the U.O. Departmental Endocrinology and Diabetology ASST FBF Sacco, Fatebenefratelli and Ophthalmic Hospital, and at the SSD of Endocrine Diseases and Diabetology ASST FBF Sacco, L. Sacco Hospital.
At the screening visit, patients being treated with sulfonylureas / glinids will be shifted, depending on the subject's biochemical and phenotypic characteristics, based on current prescribing criteria and diabetes complications, to one of 4 different types of treatment:
- GROUP 1: SGLT2 inhibitors +/- Metformin
- GROUP 2: DPP4 inhibitors +/- Metformin
- GROUP 3: GLP1-RA + Long-acting insulin +/- Metformin
- GROUP 4: SGLT2 inhibitors + DPP4 inhibitors +/- Metformin At the screening visit the clinician will evaluate which new treatment to assign to the patient, based on the subject's biochemical and phenotypic characteristics, current prescribing criteria and existing complications (Algorithm for the treatment of diabetes mellitus, SID-AMD Care Standard 2018)
Read the detailed description
Approximately 500 T2DM patients aged ≥18 years will be enrolled according to the guidelines of the American Diabetes Association (ADA) with poor glycemic control (hemoglobin A1c [A1C] ≥6.5% and ≤11% [≥58 mmol / mol and ≤97 mmol / mol]), in stabilized treatment with sulfonylureas / glinids, which meet all the study enrollment criteria.
During the study 7 visits are scheduled which coincide with the routine diabetic visits.
During the scheduled visits the patients of the study will be subjected to:
- Enrollment on the first visit if the inclusion criteria are met and those of exclusion are absent
- Anamnestic and clinical collection
- Evaluation of the type of treatment to which they have been assigned and possible modification of drug therapy in the in case that the desired glycemic target has not yet been reached up.
- Being tested
- Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas
- Keywords
- Sulfaniluree/glinidi
- Medical subject headings
- Diabetes Mellitus, Type 2, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureasDrug
Also called Shift to new generation therapeutic regimens
Substitution of sulfonylureas with other classes of new hypoglycaemic drugs. In every group, it will be evaluated:
- efficacy in terms of glycometabolic compensation (glycemia, HbA1c, lipid profile);
- effects on BMI, blood pressure monitoring and hypoglycemic risk;
- changes in renal function and microalbuminuria;
- tolerability and side effects of the new therapeutic regimes;
- therapeutic adherence;
- post-prandial glycemic excursion, determined by a 6-point glycemic diary (pre- and 2h post-prandial glucose values) to be performed at home in the week before the scheduled follow-up visit;
- effects on chronic complications of diabetes and cardiovascular safety.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | SGLT2 inibitori +/- Metformin Receives: Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas | |
| Group 2 | DPP4 inibitori +/- Metformin Receives: Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas | |
| Group 3 | GLP1-RA + Long-Acting Insulin +/- Metformin Receives: Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas | |
| Group 4 | SGLT2 inibitori + DPP4 inibitori +/- Metformin Receives: Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of the glyco-metabolic parameters
Evaluation of the new generation hypoglicemic drugs on Hba1c, blood glucose, lipidic profile
Measured: 12 months
Therapeutic adherence
Assessment of adherence to the doctor's prescription of new generation hypoglycaemic drugs
Measured: 12 months
Long-term diabetes complications
Evaluation of the effect of new generation hypoglycemic drugs on the long-term complications of diabetes compared to the effect obtained with sulphonylureas
Measured: 12 months
Secondary outcomes (3)
Values of the insulin-sensitivity
Evaluation of the effect of new generation hypoglycemic drugs on the insulin secretion of diabetes compared to the effect obtained with sulphonylureas.
Measured: 12 months
Therapeutic compliance, even in populations over 70 years.
Evaluation of the effect of new generation hypoglycemic drugs on therapeutic adherence with respect to the effect obtained with sulphonylureas even in older subjects.
Measured: 12 months
Insulin parameters after shift to new-generation hypoglycaemic therapeutic regimens
HOMA-IR and HOMA-B% insulin parameters evaluation in patients not in insulin treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start6 May 2019
- Primary completion6 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Fiorina, MD, University of Milan
- Investigators
- Paolo Fiorina, MD, PhD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272359
- Sponsor's protocol ID
- Sacco Milan
- Acronym
- Sulfa-Zero
- Status last verified
- Sep 2021
- First submitted
- 30 Oct 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garber A, Henry R, Ratner R, Garcia-Hernandez PA, Rodriguez-Pattzi H, Olvera-Alvarez I, Hale PM, Zdravkovic M, Bode B; LEAD-3 (Mono) Study Group. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009 Feb 7;373(9662):473-81. doi: 10.1016/S0140-6736(08)61246-5. Epub 2008 Sep 24.
PubMed 18819705Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 Dec 7;355(23):2427-43. doi: 10.1056/NEJMoa066224. Epub 2006 Dec 4.
PubMed 17145742Zhang Y, Hong J, Chi J, Gu W, Ning G, Wang W. Head-to-head comparison of dipeptidyl peptidase-IV inhibitors and sulfonylureas - a meta-analysis from randomized clinical trials. Diabetes Metab Res Rev. 2014 Mar;30(3):241-56. doi: 10.1002/dmrr.2482.
PubMed 24123720Charbonnel B, Schernthaner G, Brunetti P, Matthews DR, Urquhart R, Tan MH, Hanefeld M. Long-term efficacy and tolerability of add-on pioglitazone therapy to failing monotherapy compared with addition of gliclazide or metformin in patients with type 2 diabetes. Diabetologia. 2005 Jun;48(6):1093-104. doi: 10.1007/s00125-005-1751-1. Epub 2005 May 12.
PubMed 15889234Matthews DR, Charbonnel BH, Hanefeld M, Brunetti P, Schernthaner G. Long-term therapy with addition of pioglitazone to metformin compared with the addition of gliclazide to metformin in patients with type 2 diabetes: a randomized, comparative study. Diabetes Metab Res Rev. 2005 Mar-Apr;21(2):167-74. doi: 10.1002/dmrr.478.
PubMed 15386821Nauck M, Frid A, Hermansen K, Thomsen AB, During M, Shah N, Tankova T, Mitha I, Matthews DR. Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study. Diabetes Obes Metab. 2013 Mar;15(3):204-12. doi: 10.1111/dom.12012. Epub 2012 Oct 11.
PubMed 22985213Cefalu WT, Leiter LA, Yoon KH, Arias P, Niskanen L, Xie J, Balis DA, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013 Sep 14;382(9896):941-50. doi: 10.1016/S0140-6736(13)60683-2. Epub 2013 Jul 12.
PubMed 23850055Nauck MA. Incretin-based therapies for type 2 diabetes mellitus: properties, functions, and clinical implications. Am J Med. 2011 Jan;124(1 Suppl):S3-18. doi: 10.1016/j.amjmed.2010.11.002.
PubMed 21194578Del Prato S, Nauck M, Duran-Garcia S, Maffei L, Rohwedder K, Theuerkauf A, Parikh S. Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. Diabetes Obes Metab. 2015 Jun;17(6):581-590. doi: 10.1111/dom.12459. Epub 2015 Apr 6.
PubMed 25735400Nauck MA. Update on developments with SGLT2 inhibitors in the management of type 2 diabetes. Drug Des Devel Ther. 2014 Sep 11;8:1335-80. doi: 10.2147/DDDT.S50773. eCollection 2014.
PubMed 25246775Ridderstrale M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Sep;2(9):691-700. doi: 10.1016/S2213-8587(14)70120-2. Epub 2014 Jun 16.
PubMed 24948511Maedler K, Carr RD, Bosco D, Zuellig RA, Berney T, Donath MY. Sulfonylurea induced beta-cell apoptosis in cultured human islets. J Clin Endocrinol Metab. 2005 Jan;90(1):501-6. doi: 10.1210/jc.2004-0699. Epub 2004 Oct 13.
PubMed 15483097Karl DM, Gill J, Zhou R, Riddle MC. Clinical predictors of risk of hypoglycaemia during addition and titration of insulin glargine for type 2 diabetes mellitus. Diabetes Obes Metab. 2013 Jul;15(7):622-8. doi: 10.1111/dom.12072. Epub 2013 Feb 24.
PubMed 23350795Holstein A, Plaschke A, Egberts EH. Lower incidence of severe hypoglycaemia in patients with type 2 diabetes treated with glimepiride versus glibenclamide. Diabetes Metab Res Rev. 2001 Nov-Dec;17(6):467-73. doi: 10.1002/dmrr.235.
PubMed 11757083A study of the effects of hypoglycemia agents on vascular complications in patients with adult-onset diabetes. VI. Supplementary report on nonfatal events in patients treated with tolbutamide. Diabetes. 1976 Dec;25(12):1129-53. doi: 10.2337/diab.25.12.1129. No abstract available.
PubMed 992232
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Parallel Goups Study, Aimed to Evaluating Possible Benefits of the Treatment of New Generation Hypoglycaemic Drugs Compared to Sulphonylureas for the Tratment of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04272359
- Acronym / sponsor ID
- Sulfa-Zero / Sacco Milan
- Keywords
- Sulfaniluree/glinidi
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 6 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Feb 2020 (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.
This is a multicentric, prospective, parallel groups study. Patient recruitment will be carried out at the U.O. Departmental Endocrinology and Diabetology ASST FBF Sacco, Fatebenefratelli and Ophthalmic Hospital, and at the SSD of Endocrine Diseases and Diabetology ASST FBF Sacco, L. Sacco Hospital.
At the screening visit, patients being treated with sulfonylureas / glinids will be shifted, depending on the subject's biochemical and phenotypic characteristics, based on current prescribing criteria and diabetes complications, to one of 4 different types of treatment:
- GROUP 1: SGLT2 inhibitors +/- Metformin
- GROUP 2: DPP4 inhibitors +/- Metformin
- GROUP 3: GLP1-RA + Long-acting insulin +/- Metformin
- GROUP 4: SGLT2 inhibitors + DPP4 inhibitors +/- Metformin At the screening visit the clinician will evaluate which new treatment to assign to the patient, based on the subject's biochemical and phenotypic characteristics, current prescribing criteria and existing complications (Algorithm for the treatment of diabetes mellitus, SID-AMD Care Standard 2018)
Detailed description
Approximately 500 T2DM patients aged ≥18 years will be enrolled according to the guidelines of the American Diabetes Association (ADA) with poor glycemic control (hemoglobin A1c [A1C] ≥6.5% and ≤11% [≥58 mmol / mol and ≤97 mmol / mol]), in stabilized treatment with sulfonylureas / glinids, which meet all the study enrollment criteria.
During the study 7 visits are scheduled which coincide with the routine diabetic visits.
During the scheduled visits the patients of the study will be subjected to:
- Enrollment on the first visit if the inclusion criteria are met and those of exclusion are absent
- Anamnestic and clinical collection
- Evaluation of the type of treatment to which they have been assigned and possible modification of drug therapy in the in case that the desired glycemic target has not yet been reached up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureasSGLT2 inibitori +/- Metformin |
| Group 2 | – | Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureasDPP4 inibitori +/- Metformin |
| Group 3 | – | Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureasGLP1-RA + Long-Acting Insulin +/- Metformin |
| Group 4 | – | Drug: Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureasSGLT2 inibitori + DPP4 inibitori +/- Metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The size of the sample chosen is such in consideration of the average number of patients suffering from type 2 Diabetes Mellitus treated by the Diabetology Clinics of the participating structures in the study and therefore will allow us to complete enrollment within the first months of the study
Key inclusion criteria (5 listed)
- Age over 18 years;
- 6.5% <HbA1c <11%;
- Diagnosis of type 2 diabetes mellitus;
- Active treatment with sulfonylureas / glinids, both in monotherapy and in association with other long-acting hypoglycemic / insulins.
- Written informed consent of the patient or a legal guardian signed and dated
Key exclusion criteria (6 listed)
- Patients suffering from severe systemic diseases, fever, known chronic inflammatory states
- PCR determinants> 10 mg/L;
- HbA1c> 11% or HbA1c <6.5%;
- Use of corticosteroids at the time of enrollment;
- Poor patient understanding of spoken and written Italian;
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 |
|---|---|---|
| Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureasAlso: Shift to new generation therapeutic regimensSubstitution of sulfonylureas with other classes of new hypoglycaemic drugs. In every group, it will be evaluated: * efficacy in terms of glycometabolic compensation (glycemia, HbA1c, lipid profile); * effects on BMI, blood pressure monitoring and hypoglycemic risk; * changes in renal function and microalbuminuria; * tolerability and side effects of the new therapeutic regimes; * therapeutic adherence; * post-prandial glycemic excursion, determined by a 6-point glycemic diary (pre- and 2h post-prandial glucose values) to be performed at home in the week before the scheduled follow-up visit; * effects on chronic complications of diabetes and cardiovascular safety. | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Concentration of the glyco-metabolic parameters
Time frame: 12 months
Evaluation of the new generation hypoglicemic drugs on Hba1c, blood glucose, lipidic profile
Therapeutic adherence
Time frame: 12 months
Assessment of adherence to the doctor's prescription of new generation hypoglycaemic drugs
Long-term diabetes complications
Time frame: 12 months
Evaluation of the effect of new generation hypoglycemic drugs on the long-term complications of diabetes compared to the effect obtained with sulphonylureas
3 secondary outcomes
Values of the insulin-sensitivity
Time frame: 12 months
Therapeutic compliance, even in populations over 70 years.
Time frame: 12 months
Insulin parameters after shift to new-generation hypoglycaemic therapeutic regimens
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 18819705Garber A, Henry R, Ratner R, Garcia-Hernandez PA, Rodriguez-Pattzi H, Olvera-Alvarez I, Hale PM, Zdravkovic M, Bode B; LEAD-3 (Mono) Study Group. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009 Feb 7;373(9662):473-81. doi: 10.1016/S0140-6736(08)61246-5. Epub 2008 Sep 24.
- Background: PubMed 17145742Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 Dec 7;355(23):2427-43. doi: 10.1056/NEJMoa066224. Epub 2006 Dec 4.
- Background: PubMed 24123720Zhang Y, Hong J, Chi J, Gu W, Ning G, Wang W. Head-to-head comparison of dipeptidyl peptidase-IV inhibitors and sulfonylureas - a meta-analysis from randomized clinical trials. Diabetes Metab Res Rev. 2014 Mar;30(3):241-56. doi: 10.1002/dmrr.2482.
- Background: PubMed 15889234Charbonnel B, Schernthaner G, Brunetti P, Matthews DR, Urquhart R, Tan MH, Hanefeld M. Long-term efficacy and tolerability of add-on pioglitazone therapy to failing monotherapy compared with addition of gliclazide or metformin in patients with type 2 diabetes. Diabetologia. 2005 Jun;48(6):1093-104. doi: 10.1007/s00125-005-1751-1. Epub 2005 May 12.
- Background: PubMed 15386821Matthews DR, Charbonnel BH, Hanefeld M, Brunetti P, Schernthaner G. Long-term therapy with addition of pioglitazone to metformin compared with the addition of gliclazide to metformin in patients with type 2 diabetes: a randomized, comparative study. Diabetes Metab Res Rev. 2005 Mar-Apr;21(2):167-74. doi: 10.1002/dmrr.478.
- Background: PubMed 22985213Nauck M, Frid A, Hermansen K, Thomsen AB, During M, Shah N, Tankova T, Mitha I, Matthews DR. Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study. Diabetes Obes Metab. 2013 Mar;15(3):204-12. doi: 10.1111/dom.12012. Epub 2012 Oct 11.
- Background: PubMed 23850055Cefalu WT, Leiter LA, Yoon KH, Arias P, Niskanen L, Xie J, Balis DA, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013 Sep 14;382(9896):941-50. doi: 10.1016/S0140-6736(13)60683-2. Epub 2013 Jul 12.
- Background: PubMed 21194578Nauck MA. Incretin-based therapies for type 2 diabetes mellitus: properties, functions, and clinical implications. Am J Med. 2011 Jan;124(1 Suppl):S3-18. doi: 10.1016/j.amjmed.2010.11.002.
- Background: PubMed 25735400Del Prato S, Nauck M, Duran-Garcia S, Maffei L, Rohwedder K, Theuerkauf A, Parikh S. Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. Diabetes Obes Metab. 2015 Jun;17(6):581-590. doi: 10.1111/dom.12459. Epub 2015 Apr 6.
- Background: PubMed 25246775Nauck MA. Update on developments with SGLT2 inhibitors in the management of type 2 diabetes. Drug Des Devel Ther. 2014 Sep 11;8:1335-80. doi: 10.2147/DDDT.S50773. eCollection 2014.
- Background: PubMed 24948511Ridderstrale M, Andersen KR, Zeller C, Kim G, Woerle HJ, Broedl UC; EMPA-REG H2H-SU trial investigators. Comparison of empagliflozin and glimepiride as add-on to metformin in patients with type 2 diabetes: a 104-week randomised, active-controlled, double-blind, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Sep;2(9):691-700. doi: 10.1016/S2213-8587(14)70120-2. Epub 2014 Jun 16.
- Background: PubMed 15483097Maedler K, Carr RD, Bosco D, Zuellig RA, Berney T, Donath MY. Sulfonylurea induced beta-cell apoptosis in cultured human islets. J Clin Endocrinol Metab. 2005 Jan;90(1):501-6. doi: 10.1210/jc.2004-0699. Epub 2004 Oct 13.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Paolo Fiorina, MD, PhD principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T2DM (Type 2 Diabetes Mellitus) and Diet, Healthy, 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 5 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Elena Lunati, MD (02 63632256, mariaelena.lunati@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of the glyco-metabolic parameters (time frame: 12 months). The study lists 3 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 NCT04272359, which also lists 18 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 28 Sep 2021.