Piemonte combination medicine for adults with type 2 diabetes
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
This trial will test whether the Piemonte combination helps adults with type 2 diabetes lower blood sugar (HbA1c) and is safe.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Ems Industry-sponsored |
| Locations | 1 site (Hortolândia, São Paulo) |
| Trial ID | NCT05028140 on ClinicalTrials.gov |
What this trial studies
This is a Phase 3 interventional trial comparing Piemonte and comparator arms (including empagliflozin and pioglitazone/placebos) in adults with type 2 diabetes who have not reached glycemic targets on diet, exercise, and stable therapy. Eligible participants are randomized to receive Piemonte, Piemonte placebo, empagliflozin or its placebo, or pioglitazone, with regular clinic visits for safety and efficacy monitoring. The study will track glycemic control measures such as HbA1c and monitor adverse events to define the safety profile. The trial is conducted at EMS in Hortolândia, São Paulo, Brazil.
Who should consider this trial
Good fit: Adults with type 2 diabetes who have not reached HbA1c goals despite diet, exercise, and stable medication doses for at least three months, who can give informed consent and are not pregnant or breastfeeding, are ideal candidates.
Not a fit: People with type 1 diabetes, known hypersensitivity to the study compounds, pregnant or lactating individuals, recent clinical trial participants, or those with investigator-determined safety concerns are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, Piemonte could provide an effective and well-tolerated oral option to improve glycemic control for adults with type 2 diabetes.
How similar studies have performed: SGLT2 inhibitors like empagliflozin and thiazolidinediones like pioglitazone have established glycemic benefits in prior trials, while the Piemonte combination itself appears to be a newer formulation that has not been widely proven in large Phase 3 publications.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hortolândia, São Paulo
- Ems — Hortolândia, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Arthur M Kummer, MD, PhD
- Email: pesquisa.clinica@ncfarma.com.br
- Phone: +551938879851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.