NCT05028140 Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
| NCT ID | NCT05028140 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | EMS |
| Condition | Type II Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2024-10-08 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 480 participants in total. It began in 2024-10-08 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05028140 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Type II Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05028140 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 480 participants.
Is NCT05028140 currently recruiting?
Yes, NCT05028140 is actively recruiting participants. Contact the research team at pesquisa.clinica@ncfarma.com.br for enrollment information.
Where is the NCT05028140 trial being conducted?
This trial is being conducted at Hortolândia, Brazil.
Who is sponsoring the NCT05028140 clinical trial?
NCT05028140 is sponsored by EMS. The trial plans to enroll 480 participants.
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