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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Piemonte association | Experimental | 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 | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIEMONTE | Drug | Piemonte association 1 coated tablet once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin | Change from baseline in glycated hemoglobin | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events recorded during the study | 150 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur M Kummer, MD, PhD | Contact | +551938879851 | pesquisa.clinica@ncfarma.com.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EMS | Recruiting | Hortolândia | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| PIEMONTE PLACEBO |
| Other |
Placebo of Piemonte association 1 coated tablet once a day |
|
| EMPAGLIFLOZIN | Drug | Empagliflozin 25 mg 1 coated tablet once a day |
|
| PLACEBO EMPAGLIFLOZIN | Other | Placebo of empagliflozin 25 mg 1 coated tablet once a day |
|
| PIOGLITAZONE | Drug | Pioglitazone 30 mg 1 tablet once a day |
|
| PLACEBO PIOGLITAZONE | Other | Placebo of pioglitazone 30 mg 1 tablet once a day |
|
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |