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NCT Number: NCT05028140

Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus

The purpose of this study is to evaluate the efficacy and safety of Piemonte association in the treatment of type 2 diabetes mellitus

Recruiting

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Key information

Conditions

Type II Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

EMS

Hortolândia, São Paulo, Brazil

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PIEMONTE

Drug

Piemonte association 1 coated tablet once a day

PIEMONTE PLACEBO

Other

Placebo of Piemonte association 1 coated tablet once a day

Empagliflozin

Drug

Empagliflozin 25 mg 1 coated tablet once a day

PLACEBO EMPAGLIFLOZIN

Other

Placebo of empagliflozin 25 mg 1 coated tablet once a day

pioglitazone

Drug

Pioglitazone 30 mg 1 tablet once a day

PLACEBO PIOGLITAZONE

Other

Placebo of pioglitazone 30 mg 1 tablet once a day

Primary outcomes

  1. Glycated hemoglobin

    Time frame: 120 days

    Change from baseline in glycated hemoglobin

Secondary outcomes

  1. Adverse events

    Time frame: 150 days

    Incidence and severity of adverse events recorded during the study

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur M Kummer, MD, PhD

CONTACT

[email protected]

+551938879851

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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

Acronym: PIEMONTE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 31, 2021
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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