Type II DiabetesPhase 3PIEMONTENCT05028140
Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
A Phase 3 study testing PIEMONTE, EMPAGLIFLOZIN and PIOGLITAZONE in people with Type II Diabetes, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- PIEMONTE, EMPAGLIFLOZIN and PIOGLITAZONE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Oct 2024to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Type II Diabetes
- Being tested
- PIEMONTE, PIEMONTE PLACEBO, EMPAGLIFLOZIN, PLACEBO EMPAGLIFLOZIN, PIOGLITAZONE
- Keywords
- Type II diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIEMONTEDrug
Piemonte association 1 coated tablet once a day
PIEMONTE PLACEBOOther
Placebo of Piemonte association 1 coated tablet once a day
EMPAGLIFLOZINDrug
Empagliflozin 25 mg 1 coated tablet once a day
PLACEBO EMPAGLIFLOZINOther
Placebo of empagliflozin 25 mg 1 coated tablet once a day
PIOGLITAZONEDrug
Pioglitazone 30 mg 1 tablet once a day
PLACEBO PIOGLITAZONEOther
Placebo of pioglitazone 30 mg 1 tablet once a day
| Study group | Role | What they receive |
|---|---|---|
| Piemonte association | Experimental | 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. Receives: Drug: PIEMONTE; Other: PLACEBO EMPAGLIFLOZIN; Other: PLACEBO PIOGLITAZONE |
| Empagliflozin | Active comparator | 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. Receives: Other: PIEMONTE PLACEBO; Drug: EMPAGLIFLOZIN; Other: PLACEBO PIOGLITAZONE |
| Pioglitazone | Active comparator | 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. Receives: Other: PIEMONTE PLACEBO; Other: PLACEBO EMPAGLIFLOZIN; Drug: PIOGLITAZONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
Change from baseline in glycated hemoglobin
Measured: 120 days
Secondary outcomes (1)
Adverse events
Incidence and severity of adverse events recorded during the study
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start8 Oct 2024
- Primary completionJul 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028140
- Sponsor's protocol ID
- EMS1020 - PIEMONTE
- Acronym
- PIEMONTE
- Status last verified
- Dec 2025
- First submitted
- 25 Aug 2021
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05028140
- Acronym / sponsor ID
- PIEMONTE / EMS1020 - PIEMONTE
- Conditions
- Type II Diabetes
- Keywords
- Type II diabetes mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 31 Aug 2021 (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.
The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Piemonte association | Experimental | Drug: PIEMONTE, Other: PLACEBO EMPAGLIFLOZIN, Other: PLACEBO PIOGLITAZONEThe 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 PIOGLITAZONEThe 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: PIOGLITAZONEThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| PIEMONTEPiemonte association 1 coated tablet once a day | Drug | Piemonte association |
| PIEMONTE PLACEBOPlacebo of Piemonte association 1 coated tablet once a day | Other | Empagliflozin, Pioglitazone |
| EMPAGLIFLOZINEmpagliflozin 25 mg 1 coated tablet once a day | Drug | Empagliflozin |
| PLACEBO EMPAGLIFLOZINPlacebo of empagliflozin 25 mg 1 coated tablet once a day | Other | Piemonte association, Pioglitazone |
| PIOGLITAZONEPioglitazone 30 mg 1 tablet once a day | Drug | Pioglitazone |
| PLACEBO PIOGLITAZONEPlacebo of pioglitazone 30 mg 1 tablet once a day | Other | Empagliflozin, Piemonte association |
Primary outcome
Glycated hemoglobin
Time frame: 120 days
Change from baseline in glycated hemoglobin
1 secondary outcome
Adverse events
Time frame: 150 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PIEMONTE, EMPAGLIFLOZIN and PIOGLITAZONE in people with Type II Diabetes, run by EMS at 1 site in Brazil.
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 2 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur M Kummer, MD, PhD (+551938879851, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.