NCT05028140RecruitingPhase 3
Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus
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
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 25 Aug 2021
- Start date
- 8 Oct 2024
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- EMS
- Diseases
- Type 2 diabetes
- NCT number
- NCT05028140
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 480
- From 8 Oct 2024 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in a clinical trial in the year prior to this study;
Other illness
- History of alcohol abuse or illicit drug use;
- Known hypersensitivity to any of the formula compounds;
- Type 1 diabetes.
Lab values
- Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants;
Other
- Pregnancy or risk of pregnacy and lactating participants;
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| EMS Coordinator of this site? Confirm its status | Hortolândia | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.