Not provided
Not provided
Not provided
Not provided
Not provided
Strategy review
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of Egito association in the treatment of type 2 diabetes mellitus and hypertension
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egito | Experimental | The study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Egito, oral; 1 tablet empagliflozin placebo, oral; 1 tablet telmisartan placebo, oral. |
|
| Empagliflozin + telmisartan | Active Comparator | The patient must take 3 tablets once a day, as follows: 1 tablet Egito placebo, oral; 1 tablet empagliflozin, oral; 1 tablet telmisartan, oral. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Egito | Drug | EGITO Egito coated tablet. EMPAGLIFLOZIN PLACEBO Empagliflozin placebo coated tablet. TELMISARTAN PLACEBO Telmisartan coated tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin | Changes from baseline in glycated hemoglobin | 120 days |
| Systolic blood pressure (SBP) | Changes from baseline in SBP in ambulatory blood pressure monitoring | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events recorded during the study | 150 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Empagliflozin + telmisartan | Drug | Drug: EMPAGLIFLOZIN Empagliflozin 25 mg coated tablet. Drug: TELMISARTAN Telmisartan 40/80 mg coated tablet. EGITO PLACEBO Egito placebo coated tablet. |
|
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |