A Phase 3 interventional study of PIEMONTE and PIEMONTE PLACEBO in Type II Diabetes, sponsored by EMS. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by EMS · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 480 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 tablet Piemonte, oral; 1 placebo tablet of empagliflozin, oral; 1 placebo tablet of piglitazone, oral.
Drug: PIEMONTE · Other: PLACEBO EMPAGLIFLOZIN · Other: PLACEBO PIOGLITAZONE
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 placebo tablet of Piemonte, oral; 1 tablet of empagliflozin, oral; 1 placebo tablet of piglitazone, oral.
Other: PIEMONTE PLACEBO · Drug: EMPAGLIFLOZIN · Other: PLACEBO PIOGLITAZONE
The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 placebo tablet of Piemonte, oral; 1 placebo tablet of empagliflozin, oral; 1 tablet of piglitazone, oral.
Other: PIEMONTE PLACEBO · Other: PLACEBO EMPAGLIFLOZIN · Drug: PIOGLITAZONE
Piemonte association 1 coated tablet once a day
Placebo of Piemonte association 1 coated tablet once a day
Empagliflozin 25 mg 1 coated tablet once a day
Placebo of empagliflozin 25 mg 1 coated tablet once a day
Pioglitazone 30 mg 1 tablet once a day
Placebo of pioglitazone 30 mg 1 tablet once a day
Glycated hemoglobin
Change from baseline in glycated hemoglobin
Time frame: 120 days
Adverse events
Incidence and severity of adverse events recorded during the study
Time frame: 150 days
Started Oct 2024 (actual). Primary completion is estimated for Jul 2026, 21 months after the start.
Of 438 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's planned 21 months is above that.
Counting every sponsor, half of 525 studies reached it within 20 months; a quarter within 14 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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