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NCT05028140 Clinical Trial

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

Type II Diabetes Clinical Trial

— PIEMONTE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05028140
Other study ID # EMS1020 - PIEMONTE
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date March 2024
Est. completion date September 2026

Study information
Verified date March 2023
Source EMS
Contact Arthur M Kummer, MD, PhD
Phone +551938879851
Email pesquisa.clinica@ncfarma.com.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 480
Est. completion date September 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
EMS

Outcome
Type Measure Description Time frame Safety issue
Primary Glycated hemoglobin Change from baseline in glycated hemoglobin 120 days
Secondary Adverse events Incidence and severity of adverse events recorded during the study 150 days
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