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

December 1, 2025 updated by: EMS

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • Hortolândia, São Paulo, Brazil
        • Recruiting
        • EMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Piemonte association

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
Piemonte association 1 coated tablet once a day
Other: PLACEBO EMPAGLIFLOZIN
Placebo of empagliflozin 25 mg 1 coated tablet once a day
Other: PLACEBO PIOGLITAZONE
Placebo of pioglitazone 30 mg 1 tablet once a day
Active Comparator: Empagliflozin

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin
Time Frame: 120 days
Change from baseline in glycated hemoglobin
120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 150 days
Incidence and severity of adverse events recorded during the study
150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS1020 - PIEMONTE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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