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Recruiting NCT05028140

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

Phase III Interventional Type II Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PIEMONTE, PIEMONTE PLACEBO, EMPAGLIFLOZIN, PLACEBO EMPAGLIFLOZIN.
Who it may be relevant to
Registry conditions: Type II Diabetes. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug PIEMONTE
    Piemonte association 1 coated tablet once a day
  • Other PIEMONTE PLACEBO
    Placebo of Piemonte association 1 coated tablet once a day
  • Drug EMPAGLIFLOZIN
    Empagliflozin 25 mg 1 coated tablet once a day
  • Other PLACEBO EMPAGLIFLOZIN
    Placebo of empagliflozin 25 mg 1 coated tablet once a day
  • Drug PIOGLITAZONE
    Pioglitazone 30 mg 1 tablet once a day
  • Other PLACEBO PIOGLITAZONE
    Placebo of pioglitazone 30 mg 1 tablet once a day

Primary outcome measures

  • Glycated hemoglobin [Time frame: 120 days]
Secondary outcome measures (1)
  • Adverse events [Time frame: 150 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • EMS — Hortolândia

Identifiers

NCT: NCT05028140 · EMS1020 - PIEMONTE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗