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

EMS

Status and phase: Enrolling; Phase 3

Conditions: Type II Diabetes

Treatments: Drug: EMPAGLIFLOZIN; Drug: PIOGLITAZONE; Drug: PIEMONTE; Other: PLACEBO PIOGLITAZONE; Other: PLACEBO EMPAGLIFLOZIN; Other: PIEMONTE PLACEBO

Study type: Interventional

Funder types: Industry

Identifiers

NCT05028140

EMS1020 - PIEMONTE

Details and patient eligibility

About

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

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 3 patient groups

Piemonte association

Experimental group

Description:

The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 tablet Piemonte, oral; 1 placebo tablet of empagliflozin, oral; 1 placebo tablet of piglitazone, oral.

Treatment:

Other: PLACEBO EMPAGLIFLOZIN

Other: PLACEBO PIOGLITAZONE

Drug: PIEMONTE

Empagliflozin

Active Comparator group

Description:

The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 placebo tablet of Piemonte, oral; 1 tablet of empagliflozin, oral; 1 placebo tablet of piglitazone, oral.

Treatment:

Other: PIEMONTE PLACEBO

Other: PLACEBO PIOGLITAZONE

Drug: EMPAGLIFLOZIN

Pioglitazone

Active Comparator group

Description:

The study is triple-dummy, thus the patient must take 3 tablets once a day, as follows: 1 placebo tablet of Piemonte, oral; 1 placebo tablet of empagliflozin, oral; 1 tablet of piglitazone, oral.

Treatment:

Other: PIEMONTE PLACEBO

Other: PLACEBO EMPAGLIFLOZIN

Drug: PIOGLITAZONE