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

ConditionType II Diabetes

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-85

SponsorEMS

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

480 Participants

are divided into 3 treatment groups

Group A: Piemonte associationExperimental treatment 3 interventions

Group B: EmpagliflozinActive comparator 3 interventions

Group C: PioglitazoneActive comparator 3 interventions

Trial outcomes

Primary outcomes

Glycated hemoglobin

Change from baseline in glycated hemoglobin

Time frame

120 days

Secondary outcomes

Adverse events

Incidence and severity of adverse events recorded during the study

Time frame

150 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMS

Lead sponsor

Source ClinicalTrials.gov

Apply now