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

Sponsor

EMS (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05028140

Collaborator

(none)

480

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes	Drug: PIEMONTE Other: PIEMONTE PLACEBO Drug: EMPAGLIFLOZIN Other: PLACEBO EMPAGLIFLOZIN Drug: PIOGLITAZONE Other: PLACEBO PIOGLITAZONE	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Piemonte association 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.	Drug: PIEMONTE Piemonte association 1 coated tablet once a day Other: PLACEBO EMPAGLIFLOZIN Placebo of empagliflozin 25 mg 1 coated tablet once a day Other: PLACEBO PIOGLITAZONE Placebo of pioglitazone 30 mg 1 tablet once a day
Active Comparator: 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.	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 PIOGLITAZONE Placebo of pioglitazone 30 mg 1 tablet once a day
Active Comparator: 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.	Other: PIEMONTE PLACEBO Placebo of Piemonte association 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

Arm

Intervention/Treatment

Experimental: Piemonte association

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.

Drug: PIEMONTE

Piemonte association 1 coated tablet once a day

Other: PLACEBO EMPAGLIFLOZIN

Placebo of empagliflozin 25 mg 1 coated tablet once a day

Other: PLACEBO PIOGLITAZONE

Placebo of pioglitazone 30 mg 1 tablet once a day

Active Comparator: 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.

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 PIOGLITAZONE

Placebo of pioglitazone 30 mg 1 tablet once a day

Active Comparator: 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.

Other: PIEMONTE PLACEBO

Placebo of Piemonte association 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

Outcome Measures

Primary Outcome Measures

Glycated hemoglobin [120 days]
Change from baseline in glycated hemoglobin

Secondary Outcome Measures

Adverse events [150 days]
Incidence and severity of adverse events recorded during the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EMS

ClinicalTrials.gov Identifier:

NCT05028140

Other Study ID Numbers:

EMS1020 - PIEMONTE

First Posted:

Aug 31, 2021

Last Update Posted:

Sep 5, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by EMS

Type II diabetes mellitus

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Pioglitazone

Empagliflozin

Study Results

No Results Posted as of Sep 5, 2021