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

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

Official Title
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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

Conditions
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Type II Diabetes

Intervention / Treatment
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* Drug: PIEMONTE
* Other: PIEMONTE PLACEBO
* Drug: EMPAGLIFLOZIN
* Other: PLACEBO EMPAGLIFLOZIN
* Drug: PIOGLITAZONE
* Other: PLACEBO PIOGLITAZONE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piemonte association<br>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<br>* Piemonte association 1 coated tablet once a day<br>Other: PLACEBO EMPAGLIFLOZIN<br>* Placebo of empagliflozin 25 mg 1 coated tablet once a day<br>Other: PLACEBO PIOGLITAZONE<br>* Placebo of pioglitazone 30 mg 1 tablet once a day<br>|
| Active Comparator: Empagliflozin<br>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<br>* Placebo of Piemonte association 1 coated tablet once a day<br>Drug: EMPAGLIFLOZIN<br>* Empagliflozin 25 mg 1 coated tablet once a day<br>Other: PLACEBO PIOGLITAZONE<br>* Placebo of pioglitazone 30 mg 1 tablet once a day<br>|
| Active Comparator: Pioglitazone<br>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<br>* Placebo of Piemonte association 1 coated tablet once a day<br>Other: PLACEBO EMPAGLIFLOZIN<br>* Placebo of empagliflozin 25 mg 1 coated tablet once a day<br>Drug: PIOGLITAZONE<br>* Pioglitazone 30 mg 1 tablet once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin | Change from baseline in glycated hemoglobin | 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Incidence and severity of adverse events recorded during the study | 150 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type II diabetes mellitus