Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
NCT ID: NCT05028140
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
480 participants
INTERVENTIONAL
2024-10-08
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
PIEMONTE
Piemonte association 1 coated tablet once a day
PLACEBO EMPAGLIFLOZIN
Placebo of empagliflozin 25 mg 1 coated tablet once a day
PLACEBO PIOGLITAZONE
Placebo of pioglitazone 30 mg 1 tablet once a day
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.
PIEMONTE PLACEBO
Placebo of Piemonte association 1 coated tablet once a day
EMPAGLIFLOZIN
Empagliflozin 25 mg 1 coated tablet once a day
PLACEBO PIOGLITAZONE
Placebo of pioglitazone 30 mg 1 tablet once a day
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 PLACEBO
Placebo of Piemonte association 1 coated tablet once a day
PLACEBO EMPAGLIFLOZIN
Placebo of empagliflozin 25 mg 1 coated tablet once a day
PIOGLITAZONE
Pioglitazone 30 mg 1 tablet once a day
Interventions
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PIEMONTE
Piemonte association 1 coated tablet once a day
PIEMONTE PLACEBO
Placebo of Piemonte association 1 coated tablet once a day
EMPAGLIFLOZIN
Empagliflozin 25 mg 1 coated tablet once a day
PLACEBO EMPAGLIFLOZIN
Placebo of empagliflozin 25 mg 1 coated tablet once a day
PIOGLITAZONE
Pioglitazone 30 mg 1 tablet once a day
PLACEBO PIOGLITAZONE
Placebo of pioglitazone 30 mg 1 tablet once a day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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EMS
INDUSTRY
Responsible Party
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Locations
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EMS
Hortolândia, São Paulo, Brazil
Countries
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Central Contacts
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Other Identifiers
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EMS1020 - PIEMONTE
Identifier Type: -
Identifier Source: org_study_id
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