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Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT05028140•EMS

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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)

EMS

Hortolândia, São Paulo, Brazil

Key Dates

Start Date

October 8, 2024

Primary Completion Date

July 1, 2026

Completion Date

September 1, 2027

Last Updated

December 8, 2025

Enrollment

480

ESTIMATED participants

Conditions

Type II Diabetes

Interventions

PIEMONTE

DRUG

PIEMONTE PLACEBO

OTHER

EMPAGLIFLOZIN

DRUG

PLACEBO EMPAGLIFLOZIN

OTHER

PIOGLITAZONE

DRUG

PLACEBO PIOGLITAZONE

OTHER

Contacts

Arthur M Kummer, MD, PhD

CONTACT

+551938879851 pesquisa.clinica@ncfarma.com.br

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RECRUITINGNA

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Type II Diabetes MellitusIntermediate Hyperglycemia (IHG)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors

Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D]

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