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

Phase 3

Not yet recruiting

• Conditions: Type II Diabetes
• Interventions: Drug: PIEMONTE; Other: PIEMONTE PLACEBO; Other: PLACEBO EMPAGLIFLOZIN; Drug: EMPAGLIFLOZIN; Other: PLACEBO PIOGLITAZONE; Drug: PIOGLITAZONE

• Registration Number: NCT05028140
• Lead Sponsor: EMS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-31
• Status Verified: 2023-03
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Study Start: 2024-03
• Primary Completion: 2026-03
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 480

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin	PLACEBO PIOGLITAZONE	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.
Piemonte association	PIEMONTE	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.
Piemonte association	PLACEBO EMPAGLIFLOZIN	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.
Empagliflozin	PIEMONTE PLACEBO	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.
Pioglitazone	PIEMONTE PLACEBO	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.
Pioglitazone	PLACEBO EMPAGLIFLOZIN	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.
Piemonte association	PLACEBO PIOGLITAZONE	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.
Empagliflozin	EMPAGLIFLOZIN	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.
Pioglitazone	PIOGLITAZONE	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.

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin	120 days	Change from baseline in glycated hemoglobin

Secondary Outcome Measures

Name	Time	Method
Adverse events	150 days	Incidence and severity of adverse events recorded during the study