RecruitingPhase 3NCT05028140

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


Sponsor

EMS

Enrollment

480 participants

Start Date

Oct 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This Brazilian trial tests a plant-based treatment combination called the "Piemonte Association" for people with type 2 diabetes who haven't reached their blood sugar goals with standard medications and lifestyle changes alone. **You may be eligible if...** - You have been diagnosed with type 2 diabetes - Your blood sugar (HbA1c) is not well controlled despite diet, exercise, and diabetes medications at stable doses for at least 3 months - You are able to provide informed consent **You may NOT be eligible if...** - You have type 1 diabetes - You have a history of alcohol or drug abuse - You participated in another clinical trial in the past year - You are pregnant, at risk of pregnancy, or breastfeeding - You are allergic to any ingredients in the formula - Your doctor has concerns about your safety in the trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPIEMONTE

Piemonte association 1 coated tablet once a day

OTHERPIEMONTE PLACEBO

Placebo of Piemonte association 1 coated tablet once a day

DRUGEMPAGLIFLOZIN

Empagliflozin 25 mg 1 coated tablet once a day

OTHERPLACEBO EMPAGLIFLOZIN

Placebo of empagliflozin 25 mg 1 coated tablet once a day

DRUGPIOGLITAZONE

Pioglitazone 30 mg 1 tablet once a day

OTHERPLACEBO PIOGLITAZONE

Placebo of pioglitazone 30 mg 1 tablet once a day


Locations(1)

EMS

Hortolândia, São Paulo, Brazil

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NCT05028140


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