Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus

NCT05028140 — Phase 3, Recruiting, 480 participants, EMS

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National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus

Registry	NCT05028140, acronym PIEMONTE
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	480 (Estimated)
Sponsor	EMS (Industry)
Conditions	Type II Diabetes
Interventions	PIEMONTE, PIEMONTE PLACEBO, EMPAGLIFLOZIN, PLACEBO EMPAGLIFLOZIN, PIOGLITAZONE, PLACEBO PIOGLITAZONE (Drug, other)
Dates	start 2024-10-08, primary completion 2026-07-01 (estimated), completion 2027-09-01 (estimated), first posted 2021-08-31, last updated 2025-12-08
Locations	1 site in Brazil

-Summary

The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus

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+Arms and interventions

Arm	Type	Interventions	Description
Piemonte association	Experimental	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 tablet Piemonte, oral; 1 placebo tablet of empagliflozin, oral; 1 placebo tablet of piglitazone, oral.
Empagliflozin	Active comparator	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 tablet of empagliflozin, oral; 1 placebo tablet of piglitazone, oral.
Pioglitazone	Active comparator	Other: PIEMONTE PLACEBO; Other: PLACEBO EMPAGLIFLOZIN; Drug: 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.

PIEMONTE (Drug): Piemonte association 1 coated tablet once a day
PIEMONTE PLACEBO (Other): Placebo of Piemonte association 1 coated tablet once a day
EMPAGLIFLOZIN (Drug): Empagliflozin 25 mg 1 coated tablet once a day
PLACEBO EMPAGLIFLOZIN (Other): Placebo of empagliflozin 25 mg 1 coated tablet once a day
PIOGLITAZONE (Drug): Pioglitazone 30 mg 1 tablet once a day
PLACEBO PIOGLITAZONE (Other): Placebo of pioglitazone 30 mg 1 tablet once a day

+Outcome measures

Primary outcomes

Glycated hemoglobin [120 days]: Change from baseline in glycated hemoglobin

Secondary outcomes

Adverse events [150 days]: Incidence and severity of adverse events recorded during the study

+Eligibility

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form;
* Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise, and previous therapies at stable doses within 3 months.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnacy and lactating participants;
* Known hypersensitivity to any of the formula compounds;
* Type 1 diabetes.

+Locations (1)

Facility	City	Country	Status
EMS	Hortolândia, São Paulo	Brazil	Recruiting