Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
PIEMONTE
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
1 other identifier
interventional
480
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2024
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2021
CompletedFirst Posted
Study publicly available on registry
August 31, 2021
CompletedStudy Start
First participant enrolled
October 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
December 8, 2025
December 1, 2025
1.7 years
August 25, 2021
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycated hemoglobin
Change from baseline in glycated hemoglobin
120 days
Secondary Outcomes (1)
Adverse events
150 days
Study Arms (3)
Piemonte association
EXPERIMENTALThe 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 COMPARATORThe 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 COMPARATORThe 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.
Interventions
Placebo of Piemonte association 1 coated tablet once a day
Placebo of empagliflozin 25 mg 1 coated tablet once a day
Placebo of pioglitazone 30 mg 1 tablet once a day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMSlead
Study Sites (1)
EMS
Hortolândia, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2021
First Posted
August 31, 2021
Study Start
October 8, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
December 8, 2025
Record last verified: 2025-12